SystemMedical Affairs

The complete guide · November 2026

Medical insights management, explained.

Every week, the scientists a drug company sends to talk with doctors hear questions the published data does not answer. Medical insights management is how the company's medical team, called medical affairs, collects those questions from every channel, reads them together, and turns the ones that matter into a decision with a person's name on it.

This guide is for medical science liaisons and their managers, medical insights leads and analysts, therapy-area medical directors, medical information and evidence generation leads, medical excellence and operations teams, and anyone choosing software for this work. It covers scientific and practice insights. No background needed.

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A quick example · fictional

Imagine you are the medical insights lead for immunology at a mid-sized biotech, Northwind Bio, whose antibody for ulcerative colitis, a long-term bowel disease, is called Veltrimab. Your field team of 64 logged 1,812 notes this quarter. Doctors' written questions, expert meetings, conferences and surveys add 1,134 more. You used to read them in a spreadsheet and write your report weeks after the quarter closed.

On a Monday in early October, a weekly scan compares the last four weeks with the four before. One theme stands out: patients over 65. A gastroenterologist in Ohio told your colleague: "Show me remission rates in patients over 65 and I'll use it earlier." The main published papers, she said, put all ages together. Doctors in Hamburg and Nagoya ask nearly the same thing.

Your Q2 report · last quarter
Theme
Over 65, for watching
Insights
67 in the quarter
Next step
None decided
This Monday · last four weeks
Mentions
48, then 99
Behind it
9 notes, 3 countries
On file
212 patients aged 65+
+106% in four weekssame question, new paceand the data to answer it already sits in your own studies.

You read the nine notes, check that the rise is more than one busy colleague, and promote the theme to a key insight, which sends it to leadership with a recommendation. Your evidence lead has until January 30 to pool the older patients from your finished trials. Your medical information lead, who answers doctors in writing, updates the reviewed reply on this question by October 31.

What the work catches: a rising question, weeks before the next quarterly read-out would have reported it, with a next step that now has an owner.

Medical insights management guide
Part A · Understand it

What medical affairs teams hear in the field, and how a note becomes a decision

What counts as an insight, where insights come from, who may see them, how they are coded and counted, what goes wrong, and how teams work today, explained without selling anything. If you are new to medical affairs, start here.

01 · In plain words

A question from a Midwest clinic, and the long road to someone who can answer it

A drug company has two kinds of people who visit doctors. Sales representatives talk about what a medicine is approved for. Medical science liaisons, called MSLs, are scientists, often with a doctorate in pharmacy, medicine or the life sciences, who discuss the research. They work for medical affairs, the part of the company that sits between its research teams and the doctors who use its medicines.

Doctors tell MSLs things. A gastroenterologist in Ohio says she starts a drug readily in younger patients and holds back in her patients over 70, because the published trials put all ages together. After the meeting, the MSL types a short note into the company's customer relationship management system, the CRM. That note is the raw material of an insight.

One note means little. The same question from thirty doctors in nine countries means a lot: the company may be holding the data to answer it, or it may need a new study, or its materials may need a new paragraph. Someone has to read all the notes together to see that, often one medical insights lead with a spreadsheet and four other sources: questions sent to medical information (the team that answers doctors in writing), advisory board summaries, notes from medical conferences, called congresses, and surveys.

So the question from Ohio travels slowly. It sits in the CRM, gets a code, joins a slide, and reaches a medical director in a quarterly read-out, weeks after the quarter ended. By then the MSL who logged it may have stopped wondering whether anyone read it. Medical insights management is the discipline, and increasingly the software, that shortens that road and makes sure each theme ends with a decision and an owner. This guide explains how it works and how to judge it.

One age question in a Veltrimab field note, in five steps

  1. The doctor says itAn MSL hears that published results do not report response by age. The conversation is a scientific exchange.
  2. The note is loggedThe MSL writes down what was said, in the doctor's words where possible, the same day.
  3. Notes become a themeSomeone codes and groups notes from every channel, and sees that the question is rising.
  4. A person decidesThe insights lead promotes the theme, keeps watching it, merges it, or rules it out, with a reason.
  5. An owner actsA pooled analysis, an updated standard response, a slide module, a survey question. The MSL sees that it happened.

Step 3 is the subject of this guide. The people, products and figures in this example are fictional.

Unused data, counted notes, a channel leaders miss and no legal definition: four facts about field insights

Most collected data goes unused

In a 2023 survey of 243 medical affairs professionals, 79% said they use less than half of what they collect to generate insights, and 9% said they use almost all of it.1

Counting notes is the common measure

In a survey of 1,023 medical affairs professionals in 63 countries, 53% said their company counts actionable insights submitted. Only 40% measure the quality of those insights, though 67% want to.2

Medical information hears it too

In a survey of 35 US drug companies, 85% of medical information departments said they produce and identify insights.3 Those questions come from doctors the MSL may never meet.

No law defines an insight

The working definitions come from surveys and professional societies, and companies write their own. A team that never agreed on one cannot compare two quarters.1,4

MSL, scientific exchange, standard response and key insight

MSL

Medical science liaison: a scientist employed by a company to discuss research with doctors, kept apart from sales.

Scientific exchange

A conversation about the science of a disease or a medicine, as opposed to promotion. KOLs, or key opinion leaders, are the respected specialists who take part most.

Standard response

A written answer that medical information has already reviewed, ready to send when a doctor asks a common question.

Key insight

A theme a named person has promoted after reading the evidence, sent to leadership with a recommendation attached.

Fourteen terms are defined in the one-page summary.

02 · What an insight is

What separates a medical insight from a field note, a theme and a key insight

In shortA note records what one person heard. An insight is what the organization can now say after analysis and validation, and it could change a plan. A key insight is one that a named person has promoted and sent to leadership. Teams that blur these words end up counting notes and calling the count understanding.

One working definition comes from a 2023 survey by Reuters Health and Within3, which called insights "relevant information which, after analysis and validation, can drive planning, actions, or decisions".1 That sentence has three tests inside it: where the information came from, what was done to it, and what it could change. In the same survey, 41% said their team was aligned on the difference between data and insights, 47% said somewhat, and 11% said there was no clear understanding.1

The wordWhat it meansA sample from the exampleWho it is for
Field noteWhat one person heard, once, with a date and a channel"Show me remission rates in patients over 65 and I'll use it earlier."The MSL and the insights lead
Coded insightThe note with a topic, a sentiment and a doctor segment (the kind of doctor, with no name), under a versioned coding scheme, the team's agreed list of labelsTopic: use in older patients. Sentiment: concern. Segment: community gastroenterologist.Whoever counts and compares
ThemeA group of insights with one meaning, and a statement citing the notes behind it"Patients over 65: dosing and response", 174 insights in the quarterThe insights lead, who decides
Key insightA theme a named person promoted, with a recommendation and ownersThe over-65 theme with a pooled analysis due January 30The medical leadership team
Of a quarter's 2,946 insights, 174 form the over-65 theme, and 9 notes sit behind its alert

The fictional example, Q3. The 2,670 fall into 12 themes; the largest, sequencing, holds 486.

Insights captured, five channels2,946
Grouped into a theme2,670
In the over-65 theme174
Notes cited behind this week's alert9

Fictional example from this guide

Show the numbers
StageCount
Insights captured, five channels2,946
Grouped into a theme2,670
In the over-65 theme174
Notes cited behind this week's alert9

Four tests a real insight passes before it reaches a medical director

  • It has an origin you can check. A date, a channel, a segment, and close to the doctor's own words.
  • Somebody read it against other notes. Is this one doctor, or thirty in three countries? Is one colleague writing most of them?
  • It could change something. Name the plan, study, document or conversation that would differ. If nothing would, keep it as a note.
  • It has a home. A named role owns the next step, or a named person decided there is none.

A note that confirms what the team already believed still counts: a theme that holds steady for four quarters tells leadership something. The Medical Affairs Professional Society (MAPS) and Within3 describe the same two habits in their 2023 white paper. Good teams listen narrowly, for priorities set in advance, and broadly, by asking "Is there anything we're missing?"5 Those priorities are often written as key insight questions: the specific questions whose answers would change a plan.

03 · Five channels

MSL notes, inquiries, advisory boards, congresses, surveys: the bias each channel brings

In shortField notes are the largest channel and the most familiar, but MSLs visit doctors they already know. Medical information hears from doctors the field never meets. Advisory boards and surveys answer what you asked. Reading all five together shows more, but only if they share one coding scheme.

Field notes dominate a quarter's insights, at 62% in the example
MSL notes: 1,812Medical information: 604Advisory boards: 214Congress notes: 178Doctor surveys: 138
2,946insights
  • MSL notes1,812
  • Medical information604
  • Advisory boards214
  • Congress notes178
  • Doctor surveys138

Fictional example from this guide

Show the numbers
PartValue
MSL notes1,812
Medical information604
Advisory boards214
Congress notes178
Doctor surveys138
ChannelWhat it gives youIts biasHow to use it
MSL notesWhy a doctor holds a view, in conversation, in their wordsMSLs see specialists they already know, and some colleagues log more than othersLook at how many colleagues and countries a rise rests on
Medical information inquiriesThe questions doctors chose to send, with hard countsFew words of context. A new standard response can change what gets askedCheck whether a field rumor shows up here too
Advisory boardsConsidered views from a few experts, often ranked or votedSmall rooms. The agenda shapes the answers, and dozens of on-topic statements arrive in a dayWeigh as a few voices, however many statements
Congress notesWhat is new in the field and who is presenting itSpikes around one meeting, led by academic centersName the congress in any comparison between quarters
Doctor surveysA number across a defined sampleOnly answers what you askedTest a theme you already suspect

Teams know the channels sit apart. In a small MAPS member survey from early 2020, insights from different sources were not integrated in 47% of respondents' organizations.6 In the Reuters Health and Within3 survey, 76% said the way they store and share data has created silos, and 81% said their decisions are only sometimes or never informed by all relevant stakeholders.1 Those who said so most often wanted more from patients, specialists and payers.

Patients and specialists top the list of voices missing from insights

Share of those whose insights are only sometimes or never informed by all stakeholders

Patients78%
Specialist physicians or surgeons77%
Payers70%
Nurses49%
Clinical development45%
Family physicians45%
Internal commercial or marketing42%
Regulators40%

Source 1

Show the numbers
ItemValue
Patients78%
Specialist physicians or surgeons77%
Payers70%
Nurses49%
Clinical development45%
Family physicians45%
Internal commercial or marketing42%
Regulators40%

The survey was run with Within3, which sells insights software, so read its framing with that in mind. Its 243 respondents were pharmaceutical, biotech and medical affairs professionals; 70% were directors or more senior.1

04 · The rules

Scientific exchange and unapproved-use questions: the texts in force and in draft, November 2026

In shortNo regulation is written for medical insights. The work is shaped by rules on what a company's statements can prove, by FDA's draft advice on unsolicited questions, by industry codes and by privacy law. FDA's main text on unsolicited requests is still a 2011 draft, and its January 2025 guidance still carries a "not for current implementation" line.

Two terms run through this section. An off-label, or unapproved, use is one the drug's approved label does not cover, such as another condition or dose. A request is unsolicited when the doctor asks unprompted.

The rules around a field conversation have moved slowly, and two key texts stay unsettled
  1. May 2004Warner-Lambert

    More than $430 million over off-label promotion, with "Medical Liaisons" named.

  2. Dec 2011FDA draft on unsolicited requests

    Still a draft today.

  3. Sep 2021Intended-use rule in effect

    A firm's oral or written statements can be evidence.

  4. Jan 2025FDA guidance on unapproved uses; FDA AI draft

    Page still says not for current implementation.

  5. Jan 2026FDA and EMA AI principles

    Ten shared principles.

  6. Jul 2026EU AI Omnibus in force

    High-risk rules move to 2027 and 2028.

Source 7,8,9,10,11,12,13

Show the numbers
WhenWhat
May 2004Warner-Lambert
Dec 2011FDA draft on unsolicited requests
Sep 2021Intended-use rule in effect
Jan 2025FDA guidance on unapproved uses; FDA AI draft
Jan 2026FDA and EMA AI principles
Jul 2026EU AI Omnibus in force
Dec 2027EU Annex III high-risk rules apply
TextStatus, November 2026What it means for insights
21 CFR 201.128, intended usesIn force. The current rule took effect September 1, 2021.9"Oral or written statements" by a firm or its representatives can show what a product is intended for. So a theme about an unapproved use is sensitive in the wrong hands.
FDA draft on unsolicited requestsDraft since December 2011, marked "Not for implementation". These are recommendations.8Responses "should be generated by medical or scientific personnel independent from sales or marketing departments", one to one, to the question asked.
FDA guidance on scientific information on unapproved usesIssued January 2025. The Office of Management and Budget (OMB) approved its paperwork requirements, called information collections, on July 29, 2025. FDA's page and PDF, read November 3, 2026, still say "not for current implementation", and we found no FDA notice lifting that line.10Concerns what firms may send doctors. Its status is mixed: the OMB approval is done, and FDA's line is unchanged.
EFPIA Code 2026 and ABPI Code 2024EFPIA's final consolidated version is dated 2026. ABPI's has been in operation since October 1, 2024.14,15Promotion codes from the European federation of drug makers and the UK's industry association. ABPI says the "legitimate exchange of medical and scientific information" during development is allowed, provided it does not amount to promotion.15
GDPR, the EU's data protection lawIn force. The Digital Omnibus, a proposed package of EU changes, would add Article 25a under the Council's mandate of October 2026; Parliament's position is still ahead.16,17A doctor's name in a note is personal data. Section 05 explains what that asks of you.

How a doctor's unanswered question leaves a field note

An MSL often hears a question that cannot be answered on the spot. FDA's 2011 draft recommends that questions about off-label uses go to the firm's medical or scientific representative or department, with answers limited to the question asked and documented, and with no input from sales and marketing.8

A company can add a clock of its own for getting the question to medical information. The fictional company in this guide uses one business day, and we found no public benchmark for that clock. Medical information sends the written answer, often from a standard response.

Field notes can carry other duties under a company's own written procedures. Those procedures run separately, and this guide does not cover them.

05 · Who may see what

The firewall between medical and brand teams, a doctor's identity, and groups too small to show

In shortInsights flow out of medical affairs, and three limits apply. A theme about an unapproved use stays with medical. A doctor's identity stays in the source system. A count small enough to point at one person folds into "Other". Each limit needs a named approver and a record of what was removed.

Many companies call the first limit a firewall. We found no statute or FDA rule that uses the word, and a 2022 note by the law firm Sidley says "No law or regulation expressly requires" this independence; companies adopt it to reduce risk under the Food, Drug, and Cosmetic Act and the Anti-Kickback Statute.18 So it is company policy, resting on the intended-use rule, on FDA's draft advice that sales and marketing have "no input" on responses to off-label questions, and on industry codes.9,8,14

The history is the reason it exists. In 2004 Warner-Lambert agreed to plead guilty and pay more than $430 million over the marketing of Neurontin. The Justice Department said the company used "Medical Liaisons" who represented themselves, "often falsely", as scientific experts.7 That was a promotion case with no connection to insight reporting. It shows what a blurred line looks like when a regulator reads it years later.

The brand team sees the least, and only a version someone approved

Our reading of typical company policy

Stays outCount onlyDetail removedIn full
Insights leadMedical directorMedical informationBrand teamDoctor's name and contactStays outStays outStays outStays outQuote with city and practiceIn fullIn fullIn fullDetail removedOn-label scientific themeIn fullIn fullIn fullDetail removedUnapproved-use themeIn fullIn fullIn fullStays outA written-answer requestDetail removedDetail removedIn fullStays outA region count under 5In fullIn fullIn fullCount only

Our reading of the sources 8,9,16

Show the numbers
Insights leadMedical directorMedical informationBrand team
Doctor's name and contactStays outStays outStays outStays out
Quote with city and practiceIn fullIn fullIn fullDetail removed
On-label scientific themeIn fullIn fullIn fullDetail removed
Unapproved-use themeIn fullIn fullIn fullStays out
A written-answer requestDetail removedDetail removedIn fullStays out
A region count under 5In fullIn fullIn fullCount only

Your policy may differ. When a doctor asks for a written answer, the reply reaches them through the route your procedure sets, with the contact details kept in the source system.

Why a physician's name is a privacy question under GDPR, and HIPAA is usually a different one

Under GDPR, the EU's data protection law, personal data is any information about an identifiable person, and that includes a doctor named in a note. Replacing the name with a code is pseudonymization, and pseudonymized data that could be linked back still counts as personal data under recital 26.16

The European Data Protection Board adopted draft guidelines on pseudonymisation on January 16, 2025; we found no later adopted version. Its 2026 guidelines on anonymisation are a draft too.19,20 The Council's October 2026 mandate on the Digital Omnibus adds text on pseudonymized data for a party unable to identify the person. It is not law, and Parliament's position and talks are still to come.17

HIPAA, the US health privacy law, protects patients' health information held by covered entities such as providers and insurers, and a drug maker is usually not one. Its de-identification rule has two routes, a documented expert determination or the safe harbor list.21 Patient details do not make an insight better, so the practical rule is the same in both worlds.

In the noteText to checkWhat it saysThe practical rule
A doctor's nameGDPRPersonal data, and a code that could be linked back still counts16Keep names in the source system. Carry specialty, setting and region in the insight record
A patient's detailsHIPAA, for covered entitiesTwo routes to de-identify21Ask people not to write them in a note at all

Hiding a small group of doctors: an unstable count, an identifiable person and where to draw each line

A small count in a report table, called a small cell, has two problems. It is unstable, and it can point at someone. The worked math follows in section 07.

Unstable: fewer than 30

The National Center for Health Statistics suppresses proportions built on fewer than 30 in its survey standards. Those rules were written for national surveys and bind nobody in medical affairs, but they are a published line to borrow.22

Identifiable: a number you set

Three insights in one small market can mean one doctor, so teams can fold counts below a set number into "Other". We found no text that sets that number. The example uses five, and you should write yours down.

06 · Record and coding

The insight record and coding scheme that keep this quarter comparable with the last

In shortEight fields, the same for every channel, make an insight citable. A coding scheme with a version number makes counts comparable. A percentage of agreement between coders flatters the result, so test with a chance-corrected measure, kappa, and test each code group separately.

FieldExampleWhy it is there
Date of the exchangeSep 22Windows count the exchange, and the date it was typed may be days later
ChannelMSL noteShows when a survey or board asked the question directly
Doctor as a segmentCommunity gastroenterologist, high-volume practiceA theme can be built without a name
RegionOhio, United StatesSpread is the best check on a rise
Passage in the doctor's words"Show me remission rates in patients over 65."A later reader can check a code, and find what the first coder missed
Codes and scheme versionUse in older patients; concern; v4Counts compare only inside one scheme
Any requestWritten answer wantedThe question has a clock of its own
Listening priorityUse in special populationsSilence on a priority is a finding too

Topic, sentiment and segment: three code groups and how a scheme decays

Most coding schemes, often called taxonomies, code a topic, a sentiment and a doctor segment. Topic is where the arguments happen. A broad code like "unmet need" absorbs anything, so every code needs a boundary line and an example of something close to it that is left out. Change the scheme and the trend breaks: recode the earlier quarter, or draw a break in the line and say why.

How a 94% agreement figure can mean strong or weak coding

Jacob Cohen objected in 1960 to plain percent agreement because it ignores the agreement two coders reach by chance.23 His kappa takes that out: kappa = (observed agreement − chance agreement) ÷ (1 − chance agreement). Work it through with two invented schemes and the same 94% observed agreement on 200 insights:

The schemeChance agreementKappaReading
Twelve codes, fairly even60%(0.94 − 0.60) ÷ 0.40 = 0.85Strong
One code holds most insights85%(0.94 − 0.85) ÷ 0.15 = 0.60The bottom of what a health setting should accept

Illustrative chance figures. One review, by McHugh, says that any kappa below 0.60 "indicates inadequate agreement", that about half the data may then be incorrect, and that 0.60 to 0.79 is moderate.23

In one study, an AI model's coding of clinician comments cleared a review's 0.60 floor, after calibration

Cohen's kappa on 778 clinician comments, against the minimum McHugh proposes for health research

Reasons for deterioration, after calibration0.76
Care team actions, after calibration0.78
McHugh's minimum for health research0.6

Source 24,23

Show the numbers
ItemValue
Reasons for deterioration, after calibration0.76
Care team actions, after calibration0.78
McHugh's minimum for health research0.6

Those comments were about clinical care at one hospital, and the figure followed careful prompt tuning on a sample. They were not field medical notes. We found no published agreement figure for coding MSL notes.

07 · A rising theme

The arithmetic of a rising question: windows, baselines, denominators and small counts

In shortThis section counts scientific and practice questions that doctors ask. "Doubled" is a claim with four hidden choices: the window, the baseline, the denominator and the size. State all four. Check how many colleagues and countries the rise rests on. A doubling from 48 to 99 is firmer than a doubling from 12 to 25, and both can still be nothing more than a busier field team.

Two true growth figures for the over-65 question

In the example, the over-65 theme has two growth numbers. Four weeks against the four before: (99 − 48) ÷ 48 = +106%, counted in mentions. This quarter against last: (174 − 67) ÷ 67 = +160%, counted in insights. The example's map counts mentions over four weeks, and its quarterly report counts insights. Both growth figures are true, and a report that mixes them cannot be checked.

One theme grew 106% by month and 160% by quarter, on two different windows
Earlier periodLatest period
Mentions, four weeks against four weeks4899
Insights, Q3 against Q267174

Fictional example from this guide

Show the numbers
Earlier periodLatest period
Mentions, four weeks against four weeks4899
Insights, Q3 against Q267174

How firm a doubling is at 99 mentions and at 25

Counts move around by chance. A rough check treats each count as a random number and asks how wide the likely range of the ratio is. It is the ratio, times or divided by e raised to 1.96 × √(1/a + 1/b), where a and b are the two counts.

CountsRatioRough 95% rangeReading
48, then 992.061.46 to 2.91Well above no change
12, then 252.081.05 to 4.14Barely above no change. Why a smallest theme size exists

Our arithmetic. Field notes are no designed sample, so treat this as a rough guide for reading a chart. It does not prove a change in the world.

Mentions per reporting colleague: dividing out a bigger field team

A raw count rises when the team grows, when a country joins or when someone runs a logging campaign. Suppose 20 colleagues logged 48 mentions in the first window (2.4 each) and 40 colleagues logged 99 in the second (2.5 each). The count doubled and the rate per colleague barely moved. Three denominators are worth knowing, and a chart should name the one it uses:

  • Share of all insights in the window shows what the field is spending attention on.
  • Mentions per reporting colleague suits a team that is changing size.
  • Mentions per doctor interaction is the most faithful, if you can get the number from the CRM.
The same doubling disappears once a team doubles too

Invented figures: mentions per reporting colleague

2.4First window, 20 colleagues
2.5Second window, 40 colleagues

Illustrative · replace with your own numbers

Show the numbers
PeriodValue
First window, 20 colleagues2.4
Second window, 40 colleagues2.5

Five checks on a rise before it reaches the Monday meeting

  • Spread. How many colleagues and countries? In the example, the alert rests on nine notes from three countries, and the quarter's theme on 31 MSLs in nine.
  • Source. Did a survey or a board ask about the topic directly? Recording the channel shows that.
  • Calendar. A window holding the main congress will look busy. A baseline should match the window's length, because a long average is smoother and flatters the short window.
  • Scheme. Did the codes change between the two periods?
  • The falls. Look at what dropped as well. A question that halves tells you that an answer reached people, or that nobody asks any more.

How many notes it takes to know a theme exists, and how many to understand it

Qualitative research draws a useful line. In one study of 25 in-depth interviews, the range of issues appeared by the ninth interview, called code saturation. A richly textured understanding took 16 to 24, called meaning saturation.25 Interviews are a different method from field notes, so the numbers do not transfer. The lesson does: nine notes can tell you a question exists. They rarely tell you why doctors hold the view, or what would change it.

Seeing that issues exist took 9 interviews, and a rich understanding took 16 to 24

One study of 25 in-depth interviews, a different method from field notes

Range of issues appears, code saturation9 interviews
Rich understanding begins, meaning saturation16 interviews
Rich understanding reached, upper end24 interviews

Source 25

Show the numbers
ItemValue
Range of issues appears, code saturation9 interviews
Rich understanding begins, meaning saturation16 interviews
Rich understanding reached, upper end24 interviews
08 · From theme to evidence

From a rising question to an evidence gap: what data already on file can answer

In shortA theme that says "doctors want more data" is too vague to act on. A useful one names the decision the evidence would change. Then look for what the company already holds, because a pooled analysis of completed trials costs far less than a new study, and many questions need only a clearer document.

Our sample question has a real-world basis. A systematic review of 222 phase 3 trials in inflammatory bowel disease found that age was an exclusion criterion in 129 of them, or 58%. In the 32 trials that reported the figure, 763 of 14,124 patients, or 5.4%, were older than 65.26 Comorbidities were an exclusion in 76% of trials, mainly kidney, liver and heart disease.26 So a doctor asking how a drug works in her 75-year-old patient may well get no direct answer.

About 5 in 100 trial patients were over 65, in the IBD trials that reported it
5.4 in 100

patients older than 65 in 32 phase 3 inflammatory bowel disease trials (763 of 14,124)

Source 26

Show the numbers
MeasureValue
patients older than 65 in 32 phase 3 inflammatory bowel disease trials (763 of 14,124)5.4 of 100

FDA's labeling rule shows the question is an old one. The "Geriatric use" part of a US label covers people 65 and over. When studies lacked enough older subjects to tell whether they respond differently, the rule requires a statement saying so.27 A drug can be approved for adults generally with that sentence in its label, and doctors with many older patients will still ask.

Four routes out of a theme: document, pooled analysis, real-world study, new trial

An integrated evidence plan brings together evidence work across functions and countries over a product's life. A 2026 account of these plans argues that medical affairs is well placed to lead such planning, in partnership with market access and clinical development.28 A field theme enters that plan as a stated need.

FDA's real-world evidence framework matters here: evidence from traditional clinical trials "will not be considered" real-world evidence, while routine-care data can support it, and routine care is where older and frailer patients are.29 A pooled analysis combines patients from finished trials and reads them again. It is a subgroup finding, with the limits of one: the trials were not designed to answer it, so state it as descriptive unless your statisticians say otherwise.

Start with the cheapest route that would change the decision

Our judgment. Where each route typically sits for a question like the over-65 one

How far it can answer a new question →
Pool what you hold first
Reserve for the big questions
Clear up awareness gaps
Rarely worth it
Standard responseSlide modulePooled analysisReal-world studyNew trial
Time and cost →

Our reading of the sources 28,29

Show the numbers
ItemTime and cost (0–1)How far it can answer a new question (0–1)
Standard response0.100.10
Slide module0.300.22
Pooled analysis0.100.62
Real-world study0.600.56
New trial0.720.68

Many field "needs" turn out to be awareness needs: the answer exists and the doctor has not seen it. Classifying a theme before it reaches a prioritization meeting keeps that meeting short, and it protects the credibility of the gaps that do need money.

09 · What goes wrong

Where insight programs fail, from counting notes to reports that nobody acts on

In shortCompanies measure what is easy: engagements and notes submitted. The people doing the work want quality measured. Most of the failures that follow are failures of ownership and feedback, and they repeat: the same theme returns each quarter, and MSLs stop logging what nobody reads.

Field medical teams count engagements, yet want relationship and insight quality measured

Share of 1,023 respondents: measure used today against measure preferred

Used todayPreferred
KOL engagements counted92%64%
Actionable insights submitted53%63%
Quality of actionable insights40%67%
Quality of relationships with KOLs and doctors37%70%
Involvement in medical strategy31%59%

Source 2

Show the numbers
Used todayPreferred
KOL engagements counted92%64%
Actionable insights submitted53%63%
Quality of actionable insights40%67%
Quality of relationships with KOLs and doctors37%70%
Involvement in medical strategy31%59%

The measurement problem runs deep. In a follow-up paper by the same lead authors, 76% named difficulty defining and measuring the quality of MSL activities as a key challenge, 61% named reliance on quantitative standards that do not reflect MSLs' value, and only 40% said their organization measures MSL impact.30 That paper reports the same number of respondents, 1,023, from a convenience sample recruited through professional networks.

Eight common errors in medical insights work, and why each one happens

Only one of eight common failures starts when the note is written

Our judgment of where each failure starts and where it shows, using the five steps from section 01

Not hereShows hereStarts here
NoteCodingThemeDecisionActionA target on notesStarts hereNot hereShows hereNot hereNot hereTwelve ways of codingNot hereStarts hereShows hereNot hereNot hereThe vivid quoteNot hereNot hereStarts hereShows hereNot hereReporting by volumeNot hereNot hereStarts hereShows hereNot hereA statement nobody can traceNot hereNot hereStarts hereShows hereNot hereUpward onlyNot hereNot hereNot hereNot hereStarts hereNo endingNot hereNot hereShows hereStarts hereNot hereNo feedbackShows hereNot hereNot hereNot hereStarts here

Our reading of the sources 4,5

Show the numbers
NoteCodingThemeDecisionAction
A target on notesStarts hereNot hereShows hereNot hereNot here
Twelve ways of codingNot hereStarts hereShows hereNot hereNot here
The vivid quoteNot hereNot hereStarts hereShows hereNot here
Reporting by volumeNot hereNot hereStarts hereShows hereNot here
A statement nobody can traceNot hereNot hereStarts hereShows hereNot here
Upward onlyNot hereNot hereNot hereNot hereStarts here
No endingNot hereNot hereShows hereStarts hereNot here
No feedbackShows hereNot hereNot hereNot hereStarts here
  • A target on notes submitted. Four short notes then score higher than one good one. Rural territories lose to teaching hospital clusters. The trend line starts to show how the field responds to being measured.
  • Twelve ways of coding one idea. Each MSL's habits, and each country's vocabulary, split a single question into several small ones. MAPS' webinar names inconsistent capture first among its pain points.4
  • The vivid quote as the finding. One memorable remark from a famous name outweighs thirty quiet ones. A theme should carry the quote as one citation among many.
  • Reporting by volume. The largest theme leads every quarter, so the report describes the same stable subject for years, while a smaller question rises unseen.
  • A statement nobody can trace. Someone summarized the notes by hand, and the link from a sentence back to the exchange was lost. A medical director who cannot check a claim discounts it.
  • Upward only. Insights go up to leadership and never sideways or back down. The roundtables behind the MAPS white paper describe siloed systems that need multi-year IT projects to untangle.5
  • No ending. The same theme appears in four reports, each time as "emerging". Four endings cover nearly every case: promote, keep watching on a stated condition, merge, or rule it out.
  • No feedback. MAPS' webinar speakers list, as a pain point, MSLs who feel their insights are "disappearing into a black hole".4 Other roundtable participants report that MSLs see insights as a distraction from their real job.5 When nothing visibly happens, the notes get shorter, then stop.
10 · The stakes and the market

What weak insights cost medical affairs, and how far insights software has spread

In shortSurveys point to launches at risk, wasted budget and data nobody uses. No one publishes a dollar cost of a late insight, or a reliable market size for this software, and we say so. Tools are common and rarely automated: 61% use technology to collect data, and 8% call it highly automated.

185 hours

a month for monthly MSL insight reporting alone, at one top-10 company. A 2022 MSL Journal article cowritten by a software company quotes it from a 2021 item by Within3, which sells insights software. We could not read that item.31

Second-hand, one company
80%

say colleagues from other departments have asked them for insights more often over the prior 18 months.1

Reuters Health and Within3, 2023
21%

have a centralized insights database, in MAPS and Within3 polling; 9% call their process automated enough to be not overly cumbersome.5

MAPS and Within3, 2023
Respondents fear for the launch before anything else when insights fall short

Impact of not getting or not using insights; respondents could select several

Risk to product launch65%
Budget overruns32%
Missed internal deadline32%
Compliance risk24%
Missed regulatory deadline14%

Source 1

Show the numbers
ItemValue
Risk to product launch65%
Budget overruns32%
Missed internal deadline32%
Compliance risk24%
Missed regulatory deadline14%
Four in five teams use less than half of the data they collect

How much collected data is used to generate insights; 243 respondents

Under 5%5 to 20%25 to 50%50 to 75%75 to 100%
Share of respondents14%40%25%12%9%

Source 1

Show the numbers
Under 5%5 to 20%25 to 50%50 to 75%75 to 100%
Share of respondents14%40%25%12%9%

Those are opinions in a survey run with a software vendor, and they measure fear better than loss. No one publishes these figures: insights per MSL, the cost of an insights program, how late a typical theme reaches leadership, how many MSLs work worldwide, and the size of the insights software market. Section 18 shows how to measure your own.

Report rhythm is better known, though from an old and very small sample. In the second of two MAPS member surveys from 2020 (40 responses), an insight review process appeared established in 74% of organizations, usually involving medical directors. Reports went out monthly in 44% and quarterly in 38%. We read a summary of this MAPS page, not its full text.32

Spreadsheets are still in the mix for more than a third of teams

Tools used to generate insights; many teams use several

Use technology to collect data61%
Data visualization product58%
Analytics software49%
Spreadsheets37%
Say the process is highly automated8%

Source 1

Show the numbers
ItemValue
Use technology to collect data61%
Data visualization product58%
Analytics software49%
Spreadsheets37%
Say the process is highly automated8%

Some companies are redrawing field medical roles, as in a 2025 account of a "strategic scientific advisor" at one company, built around early engagement and evidence generation.33

11 · AI's limits

What AI changes in reading field notes, and what regulators say about tools like this

In shortLanguage models can code free text at a useful level once tuned, and can group inquiries by meaning. The evidence is thin and little of it comes from this field. No agreement score tells you whether a theme matters, so that call stays with a person. Most AI rules for drug development do not reach this work directly, and your own policy matters more.

Medical affairs professionals expect AI to matter far more than they use it today

367 people in 48 countries, convenience sample

Say learning about AI is important to stay competitive87%
Expect AI to be impactful in the MSL function74%
Use AI tools for KOL engagements today27%

Source 34

Show the numbers
ItemValue
Say learning about AI is important to stay competitive87%
Expect AI to be impactful in the MSL function74%
Use AI tools for KOL engagements today27%

Policies lag behind those expectations. In that survey only about a third of organizations had policies on AI use by MSLs.34 In a small 2026 survey by a software company, 49% of 79 respondents said they review every AI output by hand; the survey says it was not designed to be statistically representative.35

What the studies of AI coding show, and where they run out

  • Tuned coding can reach useful agreement. On 778 clinician comments from one hospital, a general model reached kappa of 0.76 and 0.78 after careful prompting and calibration on a 20% sample.24
  • Theme finding is uneven. On 40 health text messages, two models matched 5 of 7 themes that human analysts found on their own, and 6 or 7 of 12 when given a framework to code against. On the themes both found, coding agreement with the human coders ran from 36% to 47%. The sample was small and far from field medicine.36
  • Clustering inquiries has been shown. A University of Toronto tool grouped medical information inquiries by meaning, a demonstration of the method that reports no accuracy figure we could quote.37
  • No test on this work. We found no peer-reviewed test of AI theme detection on MSL notes against an expert reference.

Models also drift in ways a test should look for: broad codes collect anything, rare codes get few examples, sentiment is harder across languages, and a model that agrees with itself on two runs has shown only consistency. A confident wrong coder would score well on that.

Which AI rules reach an insights tool, as of November 2026

TextStatusReach
FDA draft on AI for regulatory decision-makingDraft, January 2025Says it does not address AI used for "operational efficiencies", such as internal workflows or drafting a submission, where there is no impact on patient safety, drug quality or study reliability.11 By our reading, an insights tool mostly falls there. An analysis that feeds a submission would need a fresh look.
FDA and EMA shared AI principlesTen principles, January 14, 2026Good practice for AI in medicine development, without binding force on this work.12
EU AI ActRegulation (EU) 2026/1744 in force July 27, 2026. Annex III rules December 2, 2027; Annex I product rules August 2, 2028.13By our reading, an internal insights tool is not on the Annex III high-risk list. Check any use that touches decisions about employees, such as scoring MSLs on their notes.
Draft EU GMP Annex 22 and the draft revision of Annex 11Both still drafts. On November 3, 2026, EudraLex Volume 4 lists no Annex 22 and keeps Annex 11 at its January 2011 revision.38Good manufacturing practice rules. They do not reach a medical affairs report. They are named here so that nobody assumes otherwise.
21 CFR Part 11In forceApplies to electronic records kept under FDA's records requirements or submitted to it.39 A quarterly insights report is usually neither, and your quality team decides. Electronic signatures and an audit trail are good controls either way.

The practical stance follows: treat each output as a claim that a person checks, keep every sentence linked to its source, record who decided what, and write down what the tool may and may not do. A 2026 review of digital medical affairs puts cross-functional collaboration and governance for responsible AI among the conditions for success.40

12 · How teams do it today

Who turns a field note into a decision today, and where an insights lead's quarter goes

In shortSix roles touch an insight. One person usually does most of the reading. A MAPS webinar lists five parts of a working program: collect, analyze, communicate, act, and give feedback at every step. Reading and coding take the largest share of a by-hand quarter on our illustration, and the report arrives weeks after the quarter closes.

From MSL to medical director: the six people who carry a theme

MS

MSL or field medical colleague

Holds the exchange and writes the note the same day, with many other duties around it.

Cares about: seeing that someone read it.
IL

Medical insights lead or analyst

Reads everything, keeps the scheme, writes themes and the report. Often the only person who has read the whole quarter.

Cares about: knowing in September, ahead of the October read-out.
MD

Therapy-area medical director

Sets listening priorities, chairs advisory boards and signs the report.

Cares about: the insight behind each sentence.
MI

Medical information lead

Owns inquiries and standard responses, and answers doctors in writing.

Cares about: a question arriving in its original words.
EG

Evidence generation lead

Turns gaps into analyses and publications.

Cares about: the gap and the data on file, this quarter.
GO

Medical governance

Decides what crosses to brand teams, and keeps the record of why.

Cares about: nothing unapproved leaving medical.
A by-hand quarter runs seven steps, and four of them sit with one insights lead
  1. 1Exchange and note

    The doctor speaks, and the MSL logs it in the CRM.

    MSLSame day
  2. 2Exports pulled

    CRM, medical information, boards, congresses, surveys.

    Insights leadAfter quarter end
  3. 3Read and coded

    By hand, in a spreadsheet, often against a loose scheme.

    Insights leadTwo weeks
  4. 4Grouped and counted

    Themes named, trend counted against last quarter.

    Insights leadOne week
  5. 5Report drafted

    Slides or a document, with sources where time allows.

    Insights leadOne week
  6. 6Reviewed and signed

    Medical director, then a separate brand version.

    Director, governanceDays
  7. 7Actions agreed

    In a meeting, with owners who may or may not accept.

    Leadership teamNext quarter

Illustrative · replace with your own numbers

Show the numbers
StepWhat happensWhoTime
Exchange and noteThe doctor speaks, and the MSL logs it in the CRM.MSLSame day
Exports pulledCRM, medical information, boards, congresses, surveys.Insights leadAfter quarter end
Read and codedBy hand, in a spreadsheet, often against a loose scheme.Insights leadTwo weeks
Grouped and countedThemes named, trend counted against last quarter.Insights leadOne week
Report draftedSlides or a document, with sources where time allows.Insights leadOne week
Reviewed and signedMedical director, then a separate brand version.Director, governanceDays
Actions agreedIn a meeting, with owners who may or may not accept.Leadership teamNext quarter

Where twenty-five working days go in a by-hand insights quarter

Reading and coding take the largest share of a by-hand quarter

Our estimate for one product's quarterly cycle: 25 working days. Replace with your own.

Reading and coding notes8 days
Grouping into themes and counting trend5 days
Writing the report with its sources5 days
Pulling exports from each channel3 days
Linking themes to evidence gaps and the plan2 days
Brand version, approvals and sign-off2 days

Illustrative · replace with your own numbers

Show the numbers
ItemValue
Reading and coding notes8 days
Grouping into themes and counting trend5 days
Writing the report with its sources5 days
Pulling exports from each channel3 days
Linking themes to evidence gaps and the plan2 days
Brand version, approvals and sign-off2 days

These days are spread over the weeks after a quarter closes, in between other work, so the elapsed time runs longer. In the fictional example the team signed its last three reports 41, 38 and 35 days after quarter end.

Even a practiced team signs its quarterly report more than a month after the quarter ends

Days from quarter end to signed report, by hand

41Q4 2025
38Q1 2026
35Q2 2026

Fictional example from this guide

Show the numbers
PeriodValue
Q4 202541
Q1 202638
Q2 202635

Spreadsheets, a CRM module, an outside agency or an insights platform

Spreadsheets and slides

Exports, a shared template and one skilled person. Cheap to start and flexible.

Watch for
One person holding the memory, citations kept by hand, and a scheme that drifts.

CRM insight module

Capture and tagging inside the system MSLs already use.

Watch for
The other four channels stay out, and the follow-through stays manual.

Outside agency

Analysts read and report on a set rhythm.

Watch for
Fresh eyes come at the cost of context. Check privacy terms, and how long a question takes to reach you.

Dedicated insights platform

Several channels, automated tagging, theme views and reports.

Watch for
Whether every theme traces to its notes, and whether a person decides. MAPS' webinar speakers call technology an enabler that cannot replace a framework.4
Part B · See it working

Botminds Medical Insights Management on one quarter at a fictional biotech

Part A described the work without naming a product. This part shows how Botminds does it, at a fictional company, Northwind Bio, with a fictional antibody, Veltrimab, in ulcerative colitis. Every person, theme, note, study code and figure in the screens is sample data. On the screens, HCP means health care professional.

13 · One theme, start to finish

The over-65 question in Botminds, from Monday's theme map to a named owner

In shortMonday's scan shows 48 mentions becoming 99 in four weeks, sourced to nine notes. Priya Ranvelle, the insights lead, reads them, opens the theme, promotes it to a key insight, and four actions go to their owners. The badge on the map now names who owns the next step.

One theme goes from a scan alert to four owned actions, with a person deciding in between
  1. Monday, 6:00 amScan runs

    187 new insights; the over-65 theme is up 106%.

  2. MorningNine notes read

    United States 4, Germany 3, Japan 2.

  3. NextTheme opened

    174 insights, four sub-themes, statement cited.

  4. ThenPromoted

    Key insight, with a note to leadership.

Fictional example from this guide

Show the numbers
WhenWhat
Monday, 6:00 amScan runs
MorningNine notes read
NextTheme opened
ThenPromoted
By Oct 31First action due
1

Twelve themes on one map, sized by mentions and colored by change

Priya's home is a map. Each bubble is a theme, sized by mentions from September 7 to October 4 and colored by the change on the four weeks before. A dashed outline marks a theme that stays medical-only. A small badge on each bubble gives the initials of the person who owns the next step, or "!" when it waits for her. The theme "Patients over 65: dosing and response" has gone from 48 to 99 mentions, +106%.

The theme map. The selected theme's panel shows 99 mentions against 48, the alert sourced to nine notes in three countries, what was done, and who owns the next step.
2

Replaying Monday's scan, last month against this month

Priya can replay the scan. The bubbles start at last month's size and grow to today's, so she sees which theme moved and which only looks large. Sequencing is still the biggest theme at 153 mentions, and it grew 2%. A report written by volume would lead with sequencing again.

The scan, replayed. It states its two windows on the screen, so nobody has to ask.
3

The nine MSL notes behind the alert, each with its place and date

The first question in the room is usually "says who?". The panel answers it with nine notes, each with its segment, place, colleague and date. A doctor in Illinois asks for remission rates in over-65s on steroids. A pharmacist in Ohio asks whether the maintenance interval needs adjusting with reduced kidney function. Priya can see at a glance that several colleagues in three countries logged them. Each note opens its source record, and the doctor stays a segment.

The notes behind it. Short quotes, with region, colleague and date. No doctor's name appears.
4

A theme statement with every sentence cited to its notes

She opens the theme. Four agents built it in 9.6 seconds: 174 insights from five channels, de-identified; coded, with two follow-up requests flagged; grouped into four sub-themes, +160% on Q2; and matched to evidence gap EG-14 and medical plan objective MPO-3. Each numbered citation in the statement opens the insight behind it, with the passage highlighted on the right. A heat table shows where it is heard, month by month.

The theme workspace. Five steps, the cited statement, momentum, channels and regions, with the source note open on the right. The insights lead's step is still waiting.
5

Her decision: key insight, keep watching, merge, or not a theme

An agent, the evidence and plan linker, proposes four actions, each with an owner and date: a pooled response analysis of patients 65 and over from VLT-302, VLT-305 and the extension (Omar Haddad, evidence generation lead, January 30), an MSL slide module (Lena Ortiz, field medical director, November 15), an update to standard response SRL-0412 (Sam Patel, medical information, October 31), and two questions for the Q4 survey (Priya, November 3). The agents suggest a key insight at 91% confidence. The choice is hers, and she can change any owner.

The decision. Proposed actions, the agents' reasoning, four choices, and the theme's activity. Nothing is sent until she chooses.
6

Four actions sent, and a note for the leadership team

She promotes it. A dialog lists the four actions and offers an optional note: "Raised in Q2; doubled this quarter. The pooled analysis can answer it from data we already hold." The company holds 212 patients aged 65 and over across two trials and a long-term extension, 9% of 2,356, so this question can be answered without a new study. The analysis is descriptive, and the statisticians will say how far it goes.

Promote to key insight. Each action goes to its owner, and the step is recorded in the audit trail.
7

The badge on the map changes from "!" to SP

Back on the map, the over-65 bubble no longer waits for her. Its badge reads SP: Sam Patel owns the next step, updating SRL-0412 on use in older patients, due October 31. The panel keeps what was already done: EG-14 logged in Q2 with its priority raised to high, and a Hamburg physician's question sent to medical information as request MIR-2026-08812.

Insight to action on the map. Each bubble now answers "who has this?" without opening anything.
14 · Follow-ups and filters

A physician's written question, a theme nobody owns, and the map cut by channel

In shortThree screens around the main story. A doctor's question the MSL could not answer becomes a drafted request that waits for a person. A theme with no next step shows a dashed badge. A filter resizes every bubble, so the insights lead can test whether a rise lives in one channel.

The Wisconsin question that waits for a person to confirm it

One insight in the theme, INS-30871, records a question the MSL Emily Castellan could not answer in the meeting: how long to wait before judging response in patients over 75. The physician asked for a written answer. The insight coder flagged it and drafted the request with the passage highlighted. The physician's contact stays in the CRM. Priya confirms before 5:00 pm, and medical information sends the answer. The company's rule is one business day.

The drafted request. Nothing leaves until a person confirms.
The note it came from. The insight keeps its place in the theme.

Access delays: done, with a dashed badge and nobody on the next step

Not every bubble ends in an action from medical. The access delays theme carries a dashed badge: its appeal summary is done, and coverage questions sit with market access. The panel says so, and offers an Assign button in case that is wrong. A gap like this is what a quarterly read-out tends to hide.

No open action. The theme is on watch, and the map shows that nobody holds a next step.

MSL notes alone: how the bubbles resize when one channel is filtered

Filter to MSL notes and the over-65 theme shows 58 mentions against 28, +107%. The rise holds with medical information and the other channels taken out, which is what a careful reader wants to see. Filters by region work the same way.

Field notes only. A rise that survives one channel's removal is firmer than one that does not.

All twelve themes in a table, by status, region and evidence gap

The Themes screen lists every theme with its count, its 13-week shape, its change on Q2, its top region, its evidence gap, its progress and its status. It can filter to those needing a decision, and it searches the quotes.

Themes. The largest theme has moved 3%; the over-65 theme, which waits for a decision, has moved 160%.
15 · The report

The Q3 insight report, every sentence cited, and a separate brand version with each removal listed

In shortThe report writer works from Priya's decisions, and undecided themes appear as "for discussion". The firewall guard builds a brand version and lists four removals. Medical governance approves that version, and the medical director signs with the meaning of her signature.

Priya presses "Draft the report". The report writer takes about a minute and produces the medical version: 2,946 insights, 13% more than Q2, grouped into 12 themes, with the over-65 theme first and a recommendation that the leadership team endorse the pooled response analysis. The draft carries 25 citations. Dr. Maya Chen, the medical director, can click any of them to see the note behind a sentence.

The draft. Sections on the left, citations in each sentence, the sign-off chain on the right.

What the brand team may see: four removals with a reason for each

The firewall guard, an agent, builds the brand version from the sharing rules. It removes theme T-11, an unapproved use that stays medical-only. It drops city and practice from quotes. It folds two small region cells into "Other". It leaves out medical information request detail. An item it cannot classify is removed. Nothing reaches the brand team before Dana Okafor, in medical governance, approves it.

The brand version. Each removal is listed with its reason, and the removed theme is marked in place.

Dr. Chen's electronic signature and the meaning she signs

Priya sends the report for sign-off. Dana approves the brand version. Dr. Chen signs with a password and a stated meaning: "I approve this report for the medical leadership team." In the sample data this report closed 7 days after quarter end, against 41, 38 and 35 for the three before. None of that is a customer's result.

The signature. Document, signer and meaning.
Signed and shared. Prepared, approved and signed, in order.
16 · Board, dashboard, settings

The action board, the theme momentum dashboard and the medical rules you set yourself

In shortEvery key insight ends on a board with an owner, through to impact measured. The dashboard ranks themes by change, shows the road from theme to finished action, and tracks time from quarter end to signature. The rules are settings you change, and each change is versioned and recorded.

Insight to action. Five columns, ending in impact measured. A completed sequencing analysis shows that 82% of sequencing inquiries in Q3 were answered with its reprint, in the sample data.
The dashboard. Volume by week and channel, and themes ranked by change. The 97%, 94% and 2.1 days here are the solution's design targets, shown on sample data.
Regions, the road to action, and time to report. After this decision: twelve themes found, ten decided, six key insights, two with an action done. Sample data.
Your rules. The rise that raises an alert, the smallest theme, the coding scheme, and who hears what.
Sharing and sign-off. What leaves medical, who approves it, who signs, and the read-only source connections.
17 · Who decides, and systems

Six agents read and draft while the insights lead, governance and the medical director decide

In shortEach agent has one job and a stated limit. People decide themes, confirm requests, approve the brand version and sign. Insights come in from five read-only sources, and cited themes, owned actions and a signed report come out. Your CRM and medical information system stay the systems of record.

Insight intake

Turns each CRM export row, medical information trend, board summary, congress note and survey result into one record with the doctor as a segment.

Never copies a doctor's name, practice name or contact details into the record.

Insight coder

Applies your coding scheme, and flags any question a doctor wants answered in writing, with a drafted request.

Never sends a request without a person confirming. Uncertain codes go to the insights lead.

Theme clusterer

Groups insights by meaning, names each theme in plain words, tracks it week by week, and picks the notes behind an alert.

Never merges or splits a theme on its own. It proposes, and the insights lead decides.

Evidence and plan linker

Links a theme to your evidence-gap register, your medical plan and the data you hold, and proposes actions with an owner.

Never assigns work. It proposes, and owners accept. It writes no promotional wording.

Report writer

Writes the quarterly report and decision memos from the insights lead's decisions.

Never writes a sentence without a citation. Undecided themes are marked "for discussion".

Firewall guard

Builds the brand version, and lists every removal with its reason.

Never releases on its own. An item it cannot classify is removed, and release needs governance approval.

Who signs what: the insights lead, the owners, governance and the medical director

WhoDecidesWhat the record keeps
Medical insights leadEach theme: key insight, watching, merged, or no theme. Confirms follow-up requests.Decision, reason, time
Action ownersAccept or change each proposed actionOwner, date, stage, impact
Medical governanceApproves the brand versionEvery removal and its reason
Therapy-area medical directorSigns the quarterly report, after a separate person prepared itElectronic signature with its meaning

Controls that support your own compliance and audit work come built in: separate roles for preparing, approving and signing, an audit trail of every agent step and decision, versioned rules, and export of the record. The company behind it is SOC 2 Type II audited and manages information security to ISO 27001. Whether any record falls under Part 11 or similar rules is your quality team's call.

Five insight channels and your evidence register in; cited themes and a signed report out

Five channels

  • CRM insight export of MSL notes
  • Medical information case database
  • Advisory board summaries
  • Congress notes
  • Survey platform export

Your plan and rules

  • Evidence-gap register and medical plan
  • Coding scheme, by version
  • Sharing rules and approvers
Six agents read and draft
The insights lead decides each theme
Every sentence cited to its notes

For medical

  • Theme map, with growth and owners
  • Monday scan with cited sources
  • Signed quarterly report and decision memos

For others

  • Brand version, after approval
  • Requests to medical information, after a person confirms
  • Action board for evidence, medical information and field teams

The CRM, medical information system and registers you keep

Your CRM

Stays the record of each interaction and each doctor's identity. It connects read-only.

Your medical information system

Keeps inquiries, standard responses and its own process for answering.

Your document store

Board summaries and congress notes are read and cited where they live.

Your survey platform

Results arrive as a labeled channel, so a question you asked is never mistaken for one you heard.

Your evidence-gap register and medical plan

Themes link to your gaps and objectives. You keep them.

Design targets, to be measured in your own run: 2.1 days median from a captured insight to its theme, 97% of insights coded by agents, 94% agreement with the insights lead on a 200-insight sample. These are the solution's goals, and none is a customer result.

Part C · Are you ready to automate?

Deciding on medical insights software with your own quarter: late themes, payback and a vendor test

You run medical insights, or field medical, or you hold the budget for medical excellence. This part helps you size the problem from your own data, estimate a return you can defend, check your readiness, question any vendor, including us, and plan a pilot on a quarter you already know.

18 · What late themes cost

What late themes and unread field notes cost you, and how to find your number in a week

In shortNobody publishes the dollar cost of a late insight. The costs you can count are reading hours, evidence work done twice and standard responses updated late. The bigger ones sit outside a spreadsheet: a question left open for a quarter, and MSLs who stop writing. Measure your own in a week, starting with last quarter.

2,220 hours

a year, if your monthly reporting takes the 185 hours quoted for one top-10 company. That is 185 × 12, and the article quoting it calls it more than one full-time employee.31

Our arithmetic; one company, second-hand
67%

of 1,023 medical affairs professionals rate measuring MSL performance difficult or very difficult.30

Dyer and colleagues, 2026
4%

describe their insights generation as highly efficient and in line with a well-defined strategy; 52% say there is room to improve.1

Reuters Health and Within3, 2023
Most respondents say their medical affairs function struggles to use what it collects

Share of 243 medical affairs professionals, 2023

Say storage and sharing create silos76%
Struggle to organize, integrate and use data69%
Need more aligned internal communication66%
Need better insights from what they collect59%
See a need to show faster responses46%

Source 1

Show the numbers
ItemValue
Say storage and sharing create silos76%
Struggle to organize, integrate and use data69%
Need more aligned internal communication66%
Need better insights from what they collect59%
See a need to show faster responses46%

Seven costs of a late medical insight you can size from last quarter's records

CostWhere it hidesHow to find your number in a week
Reading and coding hoursInside one person's calendar, plus helpers at quarter endAsk your insights lead and anyone who helps to list last quarter's hours by task. Multiply by a loaded rate.
Time to a read-outReport dates nobody comparesDays from each of the last four quarter ends to the signed report.
Questions seen latePast reports read only onceTake your last three key insights. When did the first note in each appear? When did leadership first see the theme? The gap is your number.
Themes with no endingRepeat lines in quarterly reportsCount themes described as "emerging" or "watching" in two or more reports with no recorded decision.
Actions with no ownerSlides and meeting minutesTake last year's recommendations. How many had a named owner, a date and a finish? Few teams know.
Written questions held upFree text in CRM notesSample 100 notes. How many hold a question a doctor wanted answered? How long did each take to reach medical information?
Analyses done twiceSeparate requests from global and affiliatesList last year's data-on-file requests and look for the same question asked by two teams.

MSLs who stop writing, doctors who stop asking: losses outside any spreadsheet

The MSL who stops writingA colleague who hears nothing back writes less, so next quarter's count falls for a reason no chart shows.
The physician's patienceA doctor who asked in writing and waited may stop asking.
A confidence cost at the leadership tableOne claim a director could not trace can discount a whole report.
What only the lead remembersA theme's history, raised in Q2 and still open, leaves with the person unless a system carries it.
19 · Your return

What automating insight work pays back: reading days, MSL admin hours and earlier decisions

In shortCount the days your team spends reading, coding and writing, and the time MSLs spend on insight admin. Then count only the hours that will go to other work. Time to a decision matters more, and it is hard to price, so report it next to the money.

Reading and writing

Days back each quarter

Exports, coding, grouping and citations shrink, and the insights lead keeps the judgment.

therapy areas × 4 quarters × days saved × 8 hours × loaded cost
Field time

Less admin for MSLs

Recoding and repeat logging fall. Count only the share that returns to doctors.

MSLs × hours a week × working weeks × share saved × loaded cost
Evidence spend

Fewer analyses run twice

A shared record shows when a question has been asked and answered.

duplicate analyses avoided × cost of one analysis
Speed

Themes seen earlier

Count weeks gained, and report them beside the dollars. Do not price them unless your finance team will sign the method.

days from first note to a decision, before and after

Working the sum for your therapy areas and field team

No published benchmark sets these inputs. All are illustrative, so replace them with your own.

Your insights work
Your field team
Your costs
Illustrative yearly value
Insights team hours freed0
Those hours, valued$0
MSL hours freed (46 working weeks)0
Those hours, valued$0
Value of time, less yearly cost$0

Formulas: therapy areas × 4 × days saved × 8 × cost; MSLs × hours × 46 × share × cost. Freed hours are worth money only if they go to other work. The result can be negative, and that is a useful answer too. Earlier decisions and duplicate analyses are left out.

20 · Readiness check

Score your insights program for automation: definitions, channels, deciders and the firewall

In shortEight questions, each scored 0 to 2, plus one for reflection. Scores of 0 to 6 say explore first, 7 to 11 say run a pilot, and 12 to 16 say you are ready to implement.

1
A shared definition of an insight

Would three colleagues give you the same answer to "what counts as an insight here"?

Why it mattersSoftware counts what you tell it to. Vague words make for confident wrong totals.
A strong answer"Written down, with examples of what does not count."
2
Coding scheme with a version

Is there one scheme across channels and countries, with a version history?

Why it mattersComparing quarters across a changed scheme produces false trends.
A strong answer"Yes, with boundary examples for each code, and we note each change."
3
Five channels within reach

Can you export last quarter's data from the CRM, medical information, boards, congresses and surveys?

Why it mattersA pilot on one channel cannot show you what the channels say together.
A strong answer"All five, with dates and segments, within a week."
4
A named person who decides each theme

When a theme rises, does one role decide its status, with a reason?

Why it mattersA rising count with no decider becomes one more slide.
A strong answer"The insights lead decides, the medical director can overrule, and both are on the record."
5
Listening priorities and key insight questions

Do you have written questions for this year whose answers would change a plan?

Why it mattersA theme is easier to rank against a stated priority, and you can see which priorities nobody has heard about.
A strong answer"Ten or so, reviewed twice a year, known to the field."
6
The medical and brand firewall

Is there a written rule for what crosses to brand teams, and a named approver?

Why it mattersAutomation makes copying easier. Your rules have to be clear enough to run as settings.
A strong answer"Written, with unapproved-use, small-group and doctor-detail rules, and a governance approver."
7
A privacy and AI position

Have privacy and legal reviewed AI reading of field notes, across your regions?

Why it mattersA doctor's name in a note is personal data under GDPR, and a third of organizations in one survey had an AI policy for MSLs.34
A strong answer"Reviewed, with names kept in the source system and a policy MSLs have read."
8
Action follow-through and feedback to MSLs

Can you show last year's key insights with owner, date and finish, and does the field see them?

Why it mattersSoftware can record actions, and only your leaders can make them happen.
A strong answer"A tracked list, reviewed each quarter, with feedback going back to the people who wrote the notes."
9
The Monday question · for reflection

If your medical director asked this Monday, "What are doctors asking about now that they weren't asking in July?", what could you answer before lunch?

Why it mattersYour answer lists the gaps, and some of them are jobs software can take on.
A strong answerA short, specific list: the theme, the notes behind it, what it would change, and who has it.
0–6

Explore

Write a definition and a first scheme, name a decider, and hand-read one month of notes with two people to see where you disagree.

7–11

Ready to pilot

Run a measured pilot on one therapy area and one past quarter, with your own hand-coded sample as the reference.

12–16

Ready to implement

Plan connections to your CRM and medical information system, your sign-off chain, your brand version rules and the rollout by therapy area.

21 · Questions for vendors

Eleven tests for an MSL insights platform, from clicking a citation to seeing the brand view

In shortGood vendors, us included, answer with a screen and a number on your data: a sentence that opens its note, kappa by code group against your own coders, and the view a brand user gets. Warning signs sit beside each answer.

A

Tracing a theme statement back to its field notes

A1

Can I click any sentence in a theme or a report and land on the passage behind it?

Why it mattersWithout that click, checking one claim means searching a CRM export.
Strong answer · warning sign
Yes, on every sentence, with a block on any sentence lacking one.
"The summary lists its sources at the end."
A2

What shows me how many colleagues and countries a rising theme rests on?

Why it mattersForty mentions from four people is four opinions.
Strong answer · warning sign
Shown on the alert, with the notes listed.
A trend line and a percentage alone.
B

Testing AI coding against your own insights lead

B1

What is your chance-corrected agreement, by code group, against our coders on our notes?

Why it mattersPercent agreement flatters an uneven scheme, and an average hides a weak group.23
Strong answer · warning sign
"We will measure it in the pilot, by group, and report rare codes apart."
"Over 95% accurate", with no reference named.
B2

What happens when I change the coding scheme?

Why it mattersA silent change makes a false trend.
Strong answer · warning sign
Versioned, with earlier quarters recoded or the break shown.
"The model learns as it goes."
B3

How do you handle languages other than English?

Why it mattersA theme can split in two because of a translation.
Strong answer · warning sign
Group by meaning, keep the original passage, and test each language.
"We translate everything first," with no check.
C

Keeping themes, doctors and small groups behind the firewall

C1

Show me what a brand user sees, and the list of what was removed.

Why it mattersA firm's statements can show what a product is intended for, so a theme about an unapproved use in the wrong hands is an exposure.9
Strong answer · warning sign
A separate version, every removal listed, released by a named approver, and removal when in doubt.
A role filter on one shared report.
C2

Where do doctors' names and contact details go?

Why it mattersThey are personal data, and pseudonymized data can still be personal data.16
Strong answer · warning sign
They stay in the source system, and the record holds a segment.
"We hash them."
C3

Is our data used to train a model for anyone else?

Why it mattersNotes hold unpublished questions and competitive views.
Strong answer · warning sign
No, in the contract, with where it is processed stated.
"Only in anonymized form."
D

Who decides a theme, who signs, and what the record proves

D1

Can the system change a theme, merge two, or send a request by itself?

Why it mattersA merge changes each trend line it touches, and someone should own that.
Strong answer · warning sign
It proposes, and a person acts, on the record.
"It auto-optimizes themes each week."
D2

What can you export for an internal audit?

Why it mattersYour auditors read records, and a demo tells them nothing.
Strong answer · warning sign
Every step and decision with person, time and version. Roles that keep preparer, approver and signer apart.
"Our product is Part 11 compliant."
D3

Show me an action a year later: who owned it, and what changed?

Why it mattersInsight to action is the part leaders ask about, and the part that is hard to fake.
Strong answer · warning sign
Owner, stage, finish and a stated impact measure.
A count of insights "activated".
22 · A pilot

Replaying a quarter you already know: a ten-week insights pilot with a decision at the end

In shortTake one therapy area and one past quarter. Hand-code a sample first. Run the software on the quarter and compare it with your codes, your report and your memory. Then run live for one month. Decide on numbers you set before you began.

A ten-week pilot tests one past quarter before one live month
Your teamVendor
Name decider; write definition and pass marks
Hand-code 300 notes with two people
Connect read-only exports; load scheme
Replay the past quarter
Compare with your codes and report
Run live for one month
Firewall test with governance
Measure and decide
Week 0246810

Illustrative · replace with your own numbers

Show the numbers
ActivityFromTo
Name decider; write definition and pass marks01
Hand-code 300 notes with two people03
Connect read-only exports; load scheme13
Replay the past quarter35
Compare with your codes and report46
Run live for one month69
Firewall test with governance79
Measure and decide910

Coding agreement, citation checks, planted firewall items: eight pilot measures

MeasureHowSet your bar before you start
Coding agreementKappa against your two coders, by topic, sentiment and segmentAbove 0.60 on every group you will use23
Your own coders' agreementKappa between your two people on the same notesThe ceiling. No tool can beat a reference that disagrees with itself
Citation checkOpen 100 sentences at random. Does the note say that?Every failure read and explained
Themes you found by handAre last quarter's key insights there?All present, in words your director accepts
Themes you missedWhat did it surface that you missed, and is it real?Your lead's judgment, written down
Lead timeFirst note to first alert on the replay, compared with your read-out dateWeeks gained, with no theme lost
Firewall testPlant unapproved-use and small-cell items; check the brand versionZero through, with each removal listed
HoursYour hours log against last quarterYour calculator's assumption, or better
Deeper questions for the steering group
  • Which channel would you turn off if it did not change any decision in the replay?
  • What does a theme need before your director will accept it without reading the notes? How does that change after three quarters?
  • Who reads what fell, as well as what rose?
  • How will MSLs learn that their note was cited? Who tells them if a theme was ruled out?
  • If two affiliates code one question differently, who settles it?
  • Which works council or employee rules apply if you look at notes by colleague? Keep performance scoring out of the pilot unless legal has reviewed it.
23 · MSL insights FAQ

Fourteen answers on MSL insights, emerging themes and who may see them

In shortFourteen short answers. Each stands on its own.

What is medical insights management?

It is how a medical affairs team collects what it hears from doctors, reads it together and turns it into decisions with owners. It covers field notes from medical science liaisons, medical information inquiries, advisory boards, congress notes and surveys. The output is a set of cited themes, a regular report and a list of actions.

What is a medical insight?

A medical insight is relevant information that, after analysis and validation, can drive planning, actions or decisions, in the definition used in a 2023 industry survey. It starts in a real exchange or data source, somebody has read it against other evidence, and something could change because of it. A single remark from one doctor is an observation until then.

What is the difference between an insight and an observation?

An observation is what one person heard once. An insight is what the organization can now say, with its working shown, and it names what would change. Many teams record both and report only the second.

What are key insight questions in medical affairs?

Key insight questions are the specific questions a medical affairs team writes down in advance because their answers would change a plan. They tell MSLs what to listen for. A 2023 MAPS and Within3 white paper pairs this narrow listening with a broad question: "Is there anything we're missing?"

What is a medical insights taxonomy?

A medical insights taxonomy, also called a coding scheme, is the team's agreed list of labels for an insight, usually a topic, a sentiment and a doctor segment. Each code needs a boundary line and an example of something close to it that is left out. Give the list a version number, because counts compare only inside one scheme.

What does an MSL insights management platform do?

It brings notes and other channels into one record, helps code and group them by meaning, shows how themes change over time, and supports a report and an action list. A good one lets you click any sentence and land on the source note. It keeps doctors' identities in the source system, and leaves each decision with a person.

How do you identify emerging themes in field medical notes?

In this work an emerging theme is a scientific or practice question that doctors ask more often. Group notes by meaning, count them inside a fixed window, and compare with a baseline of the same length. Divide by something that accounts for how much listening happened, then check how many colleagues and countries the rise rests on. A team should write down its rule, such as a doubling with at least 25 insights, before it looks.

How do you measure the quality of MSL insights?

Counting submissions rewards volume, though 53% of organizations in one global survey use that measure, and 67% say they would prefer to measure quality. Stronger measures are the share of insights cited in a theme or report, panel review of a random sample, and the time from a note to a decision. The share of themes that end in an owned action is a good test of the whole program.

How many insights should an MSL submit?

We know of no published benchmark, and a target number tends to raise volume and lower quality. Better questions are how many of your declared listening priorities got any coverage this quarter, and how many themes reached a decision with a named owner. Territories differ too much for one number to mean much.

Can brand and commercial teams see medical insights?

A common approach is to allow it only through an approved version that removes unapproved-use themes, doctor detail and small groups. We found no statute or FDA rule that uses the word firewall, and one law firm's 2022 note says no law or regulation expressly requires this independence. It is company policy that rests on the intended-use rule, FDA's draft advice on keeping sales and marketing out of off-label responses, and industry codes.

Can AI analyze MSL notes?

Models can code clinical free text at a useful level after tuning: one study reached kappa of 0.76 and 0.78 on 778 clinician comments. We found no peer-reviewed test on MSL notes, so test on your own quarter against your own coders. Deciding whether a theme matters stays with a person.

Is a doctor's name in an MSL note personal data?

Yes, under GDPR, since it identifies a natural person. Replacing it with a code is pseudonymization, and that data can still count as personal data if it could be linked back. Good practice is to keep names in the CRM and carry specialty, setting and region in the insight record.

Do FDA Part 11 or EU Annex 22 apply to a medical insights report?

Usually not directly. Part 11 applies to electronic records kept under FDA's records requirements or submitted to FDA, and your quality team decides what falls there. Draft Annex 22 is a manufacturing text and was still a draft in November 2026. An audit trail and electronic signatures are good controls in any case.

How long does a quarterly medical insights report take?

We found no public benchmark. One top-10 company is quoted at 185 hours for monthly MSL insight reporting alone, second-hand, through software vendors. In a small 2020 MAPS member survey, 38% of organizations reported quarterly and 44% monthly. Measure the days from your last four quarter ends to signature.

24 · One-page summary

The medical insights cheat sheet: nine steps from note to owner, rule status and a glossary

Print this page

In shortThe whole guide on one screen: the method, the status of the rules, the readiness scale and the terms.

The method
  1. Agree what counts as an insight, and write key insight questions.
  2. Bring five channels into one record, with doctors as segments.
  3. Code under one versioned scheme, and test it with kappa by group.
  4. Group by meaning, and cite the notes behind each statement.
  5. Count in stated windows with a stated denominator; check spread, source, calendar and falls.
  6. Have a named person decide each theme: key insight, watching, merged or no theme.
  7. Link it to the evidence gap, and look at data on file first.
  8. Give every action an owner and date, and tell the field what happened.
  9. Keep unapproved-use themes in medical. Release a brand version only after approval, with removals listed.

Readiness: score 0–2 on eight questions: 0–6 explore · 7–11 pilot · 12–16 implement.

As of November 2026: 21 CFR 201.128 counts oral or written statements · FDA's unsolicited request text is a 2011 draft · the January 2025 guidance on unapproved uses says not for current implementation, though OMB approved its collections in July 2025 · FDA's AI draft does not address operational efficiencies · no law expressly requires a firewall, by one law firm's reading · EU AI Omnibus in force July 27, 2026 · Annex 22 is a draft on manufacturing · the Digital Omnibus on GDPR is not law.

14 terms
MSL
Medical science liaison: a scientist who discusses research with doctors, kept apart from sales.
KOL
Key opinion leader: a respected specialist in a field.
HCP
Health care professional.
CRM
Customer relationship management system, where MSLs log interactions.
Scientific exchange
A conversation about the science, as opposed to promotion.
Medical information
The team that answers doctors' questions in writing.
Standard response
A reviewed written answer to a common question.
Insight
Information that, after analysis and validation, can drive a decision.
Theme
A group of insights with one meaning and a cited statement.
Key insight
A theme a named person promoted, with a recommendation.
Evidence gap
A question that needs new evidence, after mapping what exists.
Firewall
Company rules, set by policy, on what passes from medical to commercial teams.
Kappa
Agreement between coders with chance taken out.
Pseudonymization
Replacing a name with a code, kept separately. Still personal data under GDPR if it can be linked back.
25 · Sources

Sources

Accessed November 2026. Regulatory status statements are as of November 2026.

  1. State of medical affairs insights management. A Reuters Health and Within3 survey of 243 medical affairs professionals, March 2023. Within3 sells insights software. within3.com
  2. Dyer S, Hyder C, Kraemer J. Challenges of Key Performance Indicators and Metrics for Measuring Medical Science Liaison Performance: Insights from a Global Survey. Pharmacy (Basel) 13(2):51, April 2, 2025. pmc.ncbi.nlm.nih.gov
  3. DeLuca MJ, et al. Benchmarking Medical Information Services Beyond the Unsolicited Requests: A phactMI Benchmarking Survey. Ther Innov Regul Sci 59(4):848-858, 2025 (abstract). pubmed.ncbi.nlm.nih.gov
  4. Adams A, Singhvi S. Building a Framework to Manage MSL Insights. Medical Affairs Professional Society webinar slides, 2020. The presenters' views. medicalaffairs.org
  5. Identifying and Addressing "Pain Points" in the Insights Management Process. Medical Affairs Professional Society and Within3 white paper, October 2023. medicalaffairs.org
  6. McLoughlin M, Jonkman M, Zivkov M, et al. Building Medical Insights Capabilities in Medical Affairs Organizations. MAPS Insights Focus Area Working Group white paper, 2022; the members' opinions. medicalaffairs.org
  7. US Department of Justice. Warner-Lambert to Pay $430 Million to Resolve Criminal and Civil Health Care Liability Relating to Off-Label Promotion, May 13, 2004. justice.gov
  8. FDA. Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices. Draft guidance, December 2011, Docket FDA-2011-D-0868. Not for implementation; FDA's page, read November 3, 2026, still lists it as a draft. fda.gov
  9. 21 CFR 201.128, Meaning of "intended uses", 2025 edition (revised as of April 1, 2025). govinfo.gov
  10. FDA. Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products, January 2025, Docket FDA-2008-D-0053. FDA's page and copy still read "not for current implementation" on November 3, 2026. OMB's record for 0910-0686: approved without change July 29, 2025. fda.gov reginfo.gov
  11. FDA. Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. Draft guidance, January 2025, Docket FDA-2024-D-4689; FDA's page still lists it as a draft on November 3, 2026. fda.gov
  12. European Medicines Agency. EMA and FDA set common principles for AI in medicine development, January 14, 2026. ema.europa.eu
  13. European Commission. AI Act regulatory framework page (Regulation (EU) 2024/1689 and Regulation (EU) 2026/1744, in force July 27, 2026). digital-strategy.ec.europa.eu
  14. EFPIA. Code of Practice, final consolidated version 2026. efpia.eu
  15. ABPI. Code of Practice for the Pharmaceutical Industry 2024, in operation October 1, 2024, supplementary information to Clause 3.1. pmcpa.org.uk
  16. Regulation (EU) 2016/679 (GDPR), Articles 4(1), 4(5) and recital 26. publications.europa.eu
  17. Council of the European Union. Digital Omnibus, Council mandate, document 14756/26, October 2026. data.consilium.europa.eu
  18. Sidley Austin. Reexamining Biopharma Medical/Commercial Separation, Law360, October 24, 2022. sidley.com
  19. European Data Protection Board. Guidelines 01/2025 on Pseudonymisation, adopted January 16, 2025, for consultation. edpb.europa.eu
  20. European Data Protection Board. Guidelines 02/2026 on anonymisation, draft, feedback July 8 to October 30, 2026. edpb.europa.eu
  21. 45 CFR 164.514, Other requirements relating to uses and disclosures of protected health information, 2025 edition. govinfo.gov
  22. National Center for Health Statistics. Data Presentation Standards for Proportions. Vital and Health Statistics Series 2, Number 175, 2017. cdc.gov
  23. McHugh ML. Interrater reliability: the kappa statistic. Biochem Med 22(3):276-282, 2012. pmc.ncbi.nlm.nih.gov
  24. Jeong Y, et al. Leveraging ChatGPT for thematic analysis of medical best practice advisory data. JAMIA Open 8(5):ooaf126, October 27, 2025 (abstract). pubmed.ncbi.nlm.nih.gov
  25. Hennink MM, Kaiser BN, Marconi VC. Code Saturation Versus Meaning Saturation: How Many Interviews Are Enough? Qual Health Res 27(4):591-608, 2017 (abstract). pubmed.ncbi.nlm.nih.gov
  26. Vieujean S, et al. Is it time to include older adults in inflammatory bowel disease trials? A call for action. Lancet Healthy Longev 3(5):e356-e366, 2022 (abstract). pubmed.ncbi.nlm.nih.gov
  27. 21 CFR 201.57(c)(9)(v), Geriatric use, 2025 edition (revised as of April 1, 2025). govinfo.gov
  28. Fujii R, et al. Integrated Evidence Generation Planning: Why Medical Affairs is a Critical Partner. Pharmaceut Med 40(5):351-356, 2026 (abstract). pubmed.ncbi.nlm.nih.gov
  29. FDA. Framework for FDA's Real-World Evidence Program, December 2018. fda.gov
  30. Dyer SJ, Hyder C, Kraemer J, Ward P, Dollar L. Measuring the Impact of Medical Science Liaisons: A Global Cross-Sectional Survey. Cureus 18(3):e105099, March 12, 2026 (abstract). pubmed.ncbi.nlm.nih.gov
  31. Within3 post, April 8, 2022, quoting an MSL Journal article of March 2022 by Sorcero and T. Mikhelashvili, itself citing Hill L, Abbadessa M, What is the Insights gap and why should you care?, Medical Affairs Professional Society, October 2021. We could not read that 2021 item. within3.com themsljournal.com
  32. What can we learn from 2 insight surveys of MAPS membership? Medical Affairs Professional Society, Insights Focus Area Working Group, July 1, 2020 (surveys of early 2020; 95 and 40 responses of 3,448 members). We read a summary of this page, and not its full text. medicalaffairs.org
  33. Regadera Anechina L, et al. The Evolution of In-Field Medical Affairs: Introducing the Strategic Scientific Advisor. Pharmaceut Med 39(1):19-27, 2025 (abstract). pubmed.ncbi.nlm.nih.gov
  34. Dyer SJ, Shannon E, Kraemer J. Perceptions, Utilization, and Impact of Artificial Intelligence on Medical Science Liaisons. Cureus 18(4):e107157, April 16, 2026 (abstract). pubmed.ncbi.nlm.nih.gov
  35. BP Logix. 2026 AI in Medical Affairs Industry Benchmark Survey, 79 respondents, February to May 2026. BP Logix sells life sciences software; the survey says it was not designed to be statistically representative. bplogix.com
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  38. PIC/S and European Commission. Draft EU GMP Annex 22, Artificial Intelligence, consultation July 7 to October 7, 2025. EudraLex Volume 4, read November 3, 2026, lists no Annex 22 and Annex 11 at its January 2011 revision. picscheme.org health.ec.europa.eu
  39. 21 CFR 11.1, Scope, 2025 edition (revised as of April 1, 2025). govinfo.gov
  40. Lalwani A, et al. Article on digital change in medical affairs. Pharmaceut Med 40(6):469-483, 2026 (abstract). pubmed.ncbi.nlm.nih.gov
Next step

See it on your own field notes.

Explore the solution, or bring one past quarter of insights, your coding scheme and your evidence-gap register. We will run them, show you which themes rose and when, and let your insights lead check every citation.

botminds.ai The complete guide to medical insights management · November 2026. Northwind Bio, Veltrimab, every person, study code, theme, request number and figure in the example and the screens are fictional. Regulatory status is as of November 2026. This guide covers scientific and practice insights; other duties that attach to field notes sit under a company's own procedures and outside this guide. It is general information and does not give legal advice; check the sources and your own counsel before relying on it.