Every drug in development has rivals: other companies testing medicines for the same patients. Most of what those rivals do becomes public, in a trial record edited on a Tuesday, a row on a web page, one sentence on an investor call. Competitive pipeline tracking is the weekly work of finding those changes in public sources and telling your own program team which ones affect their plans.
This guide is for competitive intelligence leads and analysts, program leads, clinical operations, medical affairs, business development, and the legal and compliance colleagues who ask where the information came from. No background in trial registries needed.
Imagine you run rival tracking at a mid-size drug company, as its competitive intelligence lead. Your psoriasis tablet, IM-7740, is in a mid-stage trial (Phase 2b), with results due in September 2027. The large final-stage trial (Phase 3) is planned to start in the second quarter of 2028. A rival, Arnholt Bio, has a drug called ORX-23 that works the same way in the body, and it has sat in Phase 2 on your slides for months.
On Monday, October 5, 2026, nothing has been announced. But the public record of Arnholt's trial, NCT07166402, reads differently from last week's copy, and the "Phase 3" row on Arnholt's pipeline page is new.
Trial record · last Monday
Status
Not yet recruiting
Study start
October 2026 (estimated)
Primary completion
March 2028 (estimated)
Trial record · this Monday
Status
Recruiting
Study start
October 3, 2026 (actual)
Primary completion
March 2028 (estimated)
First patient is inRival data may come before your Phase 3 startsMarch 2028, when the trial's main data should be complete, falls before the second quarter of 2028, and the two drugs share a mechanism.
Careful tracking catches the edit the week it appears, keeps the old and new text side by side, and gets the question to your program lead while the Phase 3 design can still change.
How rival drug programs become visible in public, how fast each source moves and where the legal line runs
The sources, their clocks, the dates and results people misread, the rules on what you may collect, and how teams work today, explained without selling anything. If you have never opened a trial record, start here.
01 · In plain words
What tracking a rival's pipeline means: finding out what changed, and whether it touches your plan
A drug company's pipeline is the set of medicines it is testing. Each moves through stages: laboratory work, then Phase 1, Phase 2 and Phase 3 trials in people, then a filing with a regulator, then approval. Rival companies are often testing medicines for the same patients at the same time. Who gets there first, and with what results, decides which trials you should run, what you should compare your drug against, and sometimes whether to continue at all.
Companies do not send you a note when something changes. They edit a record on a trial registry, a public database where trials must be listed. They add a row to the pipeline page of their website. They say a sentence on a call with investors. They post an abstract, a short summary of results, for a medical congress. A regulator adds a line to an approval database. Each of these is public, and each lives in a different place on a different schedule.
Somebody has to read all of that and connect it. That person is usually a competitive intelligence analyst (competitive intelligence is often shortened to CI). Traditionally the analyst pastes the findings into a slide deck that a program team reviews every month or quarter. The deck is out of date while it is being built, and months later nobody can say which sentence a claim came from.
Tracking means keeping an accurate, sourced answer to four questions about every rival that matters: what stage it is in, when it next reads out, what it last showed, and what a regulator has done about it. A readout is the moment a trial's main result becomes known. The fifth question is the one people pay for: what this means for us, this week. Software can help with the first four. The fifth stays with people.
The five stages of a rival move, from a public edit to a decision on your program
A rival actsA first patient is dosed, a site opens, a date slips, a filing is accepted.
The act surfaces in publicIn a registry record, a pipeline page, a call, an abstract or an agency database, days or months later.
Someone finds it and checks itCompare against the last copy, merge duplicates, confirm the source. This step is the subject of this guide.
Someone says what it meansA short written view for one program team, with an owner for each action.
Your plan changes, or holdsA trial design, a site list, a comparator, a deal, a stop.
Step 3 is where most of the hours go, and step 4 is where most of the value lies.
Things that surprise people about competitor drug tracking
Most trials appear before the first patient
In our count, about 7 in 10 industry Phase 2 and Phase 3 trials that started in 2024 were posted on ClinicalTrials.gov, the US registry, before their start date.1
A planned date may sit untouched for a year
A trial's estimated finish date falls under a general once-a-year update rule. Only the actual date runs on a 30-day clock.2
A decision date is seldom published by the regulator
A rule of the US Food and Drug Administration (FDA) keeps an unapproved application's existence confidential unless it is already public, so the date people call the PDUFA date, FDA's goal for acting, usually comes from the company.3 FDA can also act well ahead of it.4
The legal limit is about how you learned it
A rival's trial result on its website is fair to read. The same result from a study doctor at a dinner can be a trade secret problem and an insider trading problem.5,6
The words on a competitive landscape: readout, primary completion, top-line and watch list
Readout
The moment a trial's main result becomes known, usually first to the sponsor (the company running the trial) and then to the public.
Primary completion
The date the last participant gave data for the trial's main measure.
Top-line
A sponsor's first short statement of whether a trial met its main goal.
Watch list
The named rival drugs and indications (the diseases a drug is meant to treat) a team follows for one of its own programs.
Registries, company pages, investor calls, congress abstracts and agency databases each answer a different question
In shortAlmost everything in a defensible landscape comes from five public families of source. Only registries run on a legal clock. Company statements come fastest and leave most out. Agency databases are the closest to final. No single source answers all four questions, which is why a landscape built on one of them has holes.
No public source answers every question, so a landscape needs all five
How well each source family answers each question about a rival
RarelySometimesOftenReliably
What stageWhen nextWhat it showedWhat a regulator didTrial registriesReliablyOftenSometimesRarelyPipeline pages and press releasesReliablySometimesOftenSometimesInvestor callsOftenReliablySometimesSometimesCongress abstractsSometimesSometimesReliablyRarelyAgency databasesOftenSometimesSometimesReliably
Our reading of the sources2,7,8,9 · Our judgment from how each source is built. Results do reach registries, on a later clock.
Show the numbers
What stage
When next
What it showed
What a regulator did
Trial registries
Reliably
Often
Sometimes
Rarely
Pipeline pages and press releases
Reliably
Sometimes
Often
Sometimes
Investor calls
Often
Reliably
Sometimes
Sometimes
Congress abstracts
Sometimes
Sometimes
Reliably
Rarely
Agency databases
Often
Sometimes
Sometimes
Reliably
Source
Why it moves
What it is good for
Where it misleads
Trial registries
Legal duty on the sponsor, and the US National Institutes of Health (NIH) has up to 30 days to post a drug trial's registration2,10
Estimated dates may lag by up to a year. A record can be silent on a phase 1 program11
Pipeline pages and press releases
When the company chooses
The company's own statement of phase and plans
A page can change with no notice and no history. In one study of 70 research press releases, 47% carried spin, wording that emphasizes benefit12
Investor calls and filings
Quarterly, or at events. US securities rules push news into public channels13
Timing guidance found nowhere else
Guidance, a company's own stated timing, can move
Congress abstracts and programs
The congress calendar. The European Hematology Association's (EHA) 2026 terms, for one, embargo abstracts from submission until release14
Numbers, and the session date as a readout date
Interim data. Most abstracts never become full papers15
Agency databases
When the agency acts, and in the EU by a monthly list16
Approvals, wording of the indication, review letters17
Short on forward dates. The European Medicines Agency's (EMA) list gives the medicine and indication, and its page lists no applicant field16
The registry you read depends on where the rival runs its trials
ClinicalTrials.gov held 610,050 records on November 3, 2026, the public interface reports.1 It is the largest source, and it is still only one. The World Health Organization lists 18 primary registries in its network, among them the EU's CTIS, Japan's jRCT, China's ChiCTR, Korea's CRiS and India's CTRI, and it says each meets criteria for content, quality and validity.18 A rival running its first trials in Japan or China can be invisible on a watch list built only from the US record.
In the European Union, the Clinical Trials Information System, or CTIS, has run under revised transparency rules since June 18, 2024. Its information must be public unless an exemption applies, such as personal data or commercially confidential information, and the portal shows items such as the EU trial number, the sponsor and the start and end dates of recruitment.7
03 · Registry clocks
The ClinicalTrials.gov update rules: 21 days to register, 30 days for real events, 12 months for everything else
In short42 CFR Part 11 sets deadlines field by field. Fields that mark a real event, such as first patient, a site opening or a trial stopping, carry 30-day clocks. Plans do not. So a status change tells you something happened recently, and an unchanged estimate tells you very little.
Events run on a 30-day clock, while a planned date can wait a year
Longest time the US rule allows, in calendar days
Register, after the first participant enrolls21
Update overall status, with why stopped30
Update each site's status30
Update actual start and primary completion dates30
NIH posts drug trial registration, after submission30
Refresh an estimated date and other fields365
Submit results, after primary completion365
Source19,2,10,20 · Results may be delayed with a certification, for example when seeking approval of a new use.
Show the numbers
What must be sent or posted
Days
Register, after the first participant enrolls
21
Update overall status, with why stopped
30
Update each site's status
30
Update actual start and primary completion dates
30
NIH posts drug trial registration, after submission
30
Refresh an estimated date and other fields
365
Submit results, after primary completion
365
Read the rule as an intelligence problem and it tells you where to look. Study start date, overall recruitment status, individual site status, and the actual primary and study completion dates each have a 30-day duty, and a status of suspended, terminated or withdrawn must come with a stated reason.2 These are the fields worth comparing week by week.
The same section says most other registration information must be updated "not less than once every 12 months".2 An estimated completion date is in that group until the trial actually reaches it. A sponsor that re-plans a readout may have up to a year before the record has to agree, unless the plan changes through a protocol amendment that is communicated to participants, which carries its own 30-day duty.
The trials the US registry rule leaves out, which become blind spots on a landscape
The rule requires four things together for a drug trial: it is interventional (participants are assigned a treatment), its phase is other than phase 1, it studies an FDA-regulated product, and it has a US link such as a US site or a US investigational new drug application.11 So three kinds of program can be missing with no one breaking a rule:
First-in-human work. Phase 1 falls outside the requirement, though many sponsors list voluntarily. Our count shows 30,391 industry-led phase 1 records on the site, leaving out combined phase 1/2 records.1
Trials with no US link. A trial run entirely abroad may sit only on a national registry.18
Non-interventional studies. Observational work that may hint at a sponsor's next move.
How much enforcement stands behind a registry date
Do not treat the clocks as a guarantee. In a widely cited audit, 40.9% of 4,209 trials due to report did so within the one-year deadline, and 63.8% had submitted at any time, as of September 2019; industry sponsors did better than other non-government sponsors.21 FDA's list of Notices of Noncompliance holds 11 letters from April 2021 to October 2026, three of them dated October 2026.22
FDA has posted 11 registry noncompliance notices in six years, three of them in 2026
32021
12022
12023
12024
22025
32026
Source22 · Our tally of the dated list, content current October 30, 2026. 2026 is a part year. The page says FDA could pursue civil money penalties and does not report one.
Show the numbers
Period
Value
2021
3
2022
1
2023
1
2024
1
2025
2
2026
3
04 · What the registry shows
How early rival trials appear on ClinicalTrials.gov, and how stale their planned dates get: our count
In shortWe counted, using the registry's public data on November 3, 2026. Seven in ten industry trials that started in 2024 were visible before their first patient. Among open trials with an estimated finish date, about one in six shows a date already in the past. A record is good early warning and a weak clock.
Seven in ten rival trials are visible before they start
Industry-led Phase 2 and Phase 3 trials with an actual start date in 2024: when each was first posted, against its start date
Before start0 to 21 days after22 to 90 days afterMore than 90 days after
2,033 trials69.7%13%9%
Source1 · Our count. We used 2,033 of the 2,249 trials, those giving an actual start date to the day. Phase 2 here includes combined Phase 1/2 records and Phase 3 includes Phase 2/3 (427 and 96 of the 2,249). Late posting does not show a breach: many trials abroad fall outside the US rule, and the rule counts from enrollment to submission.
Show the numbers
Before start
0 to 21 days after
22 to 90 days after
More than 90 days after
2,033 trials
69.7%
13%
8.3%
9%
Two things follow. If you compare records weekly, you will usually see a rival trial before its first patient, often with planned sites and enrollment attached. And a delay sits between the sponsor and you: first submission to first posting took a median of 7 days in this group, and 26 days at the 90th percentile.1 The first public sign of an event therefore lags the event by days or weeks, even when everyone is on time.
One in six open trial estimates is already in the past
16 in 100
open industry Phase 2 and Phase 3 trials with an estimated primary completion date show a date earlier than November 3, 2026: 1,248 of 7,764
Source1 · Our count. Open means recruiting, active, not yet recruiting or enrolling by invitation. Phase 2 includes combined Phase 1/2 records. A past date may be a late update or a trial that has moved on. Separately, 1,487 of all 8,706 open trials (17%) had no update posted in the prior 12 months.
Show the numbers
Measure
Value
open industry Phase 2 and Phase 3 trials with an estimated primary completion date show a date earlier than November 3, 2026: 1,248 of 7,764
16 of 100
What nobody has settled. We found no independent, peer-reviewed measure of how far estimated primary completion dates move before they settle, and we did not read the registry's version history ourselves, so this guide has no count of its own. One data company's blog reports its daily comparison of tracked records from March 27 to August 7, 2026: 74% of 6,444 completion-date changes moved later, with a median push of 153 days.23 That is a vendor's unreviewed count of movement in one window, and we have not reproduced it.
You can measure your own: each ClinicalTrials.gov record links to its earlier versions through History of Changes.24 Take 30 rival trials that have finished and compare the first estimate with the actual date.
The number of trials to read keeps rising: industry Phase 2 and Phase 3 starts by year
About 2,500 industry Phase 2 and Phase 3 trials carry a 2025 start date, up from about 2,000 in 2016
01,0002,0003,0002,524
20162018202020222024
Source1 · Our count, by start date, ClinicalTrials.gov only, with Phase 1/2 and Phase 2/3 records included. 354 of the 2025 records still mark the start date as estimated. Late registrations can still add to recent years.
Show the numbers
Start year
Trials
2016
1,986
2017
1,949
2018
2,120
2019
2,096
2020
2,202
2021
2,717
2022
2,458
2023
2,337
2024
2,249
2025
2,524
A single indication is small and lumpy by comparison. Trials listing psoriasis as a condition ran from 17 to 48 starts a year over the same ten years, on the same count.1 That is the size of the job for one watch list: a few dozen new records a year, and every existing record to re-read.
05 · Reading a readout date
Primary completion, study completion and top-line: why a rival's readout date is an estimate built on an estimate
In shortCount a readout from primary completion, and check whether the date is marked estimated or actual. The study completion date can sit a year or more later. Then write down what kind of date you hold, because guidance, a congress slot, a goal date and a registry estimate deserve different trust.
The rule defines the completion date, which it also calls the primary completion date, as the date the final subject was examined or treated "for the purposes of final collection of data for the primary outcome", whether the trial finished as planned or was terminated.25 The study completion date adds secondary outcomes and adverse events, up to the last visit.25
A Phase 3 trial with a main measure at week 16 and a year of follow-up after it can report long before it finishes. An analyst who counts from study completion is about a year late.
Every date is labeled estimated or actual. An estimate is the sponsor's plan. Once the trial reaches it, the sponsor must change the date to actual within 30 days and give the actual enrollment.2 That change is itself worth catching: when a date flips to actual, the data exist. The sponsor knows soon after, and the one-year results clock has begun.20
Dates that come early are the least firm, so label which kind you hold
How firm it is →
Firm, but late
Firm and early
Weak and late
Early, but weak
Actual completion dateCongress session dateTarget action dateInvestor guidanceEstimated completion
How early you get it →
Our reading of the sources2,8 · Our judgment. Place your own sources after you have scored a year of them.
Show the numbers
Item
How early you get it (0–1)
How firm it is (0–1)
Actual completion date
0.25
0.75
Congress session date
0.42
0.62
Target action date
0.60
0.50
Investor guidance
0.50
0.30
Estimated completion
0.75
0.16
Working a readout estimate through, with the fictional numbers from the example
Step
ORX-23 in the example
What to write beside it
Start
October 3, 2026 (actual), from the record
A fact, with the version of the record that says so
Primary completion
March 2028 (estimated), from the record
About 18 months away. The sponsor's plan
Top-line
Not stated
Your lag, from your own history of similar trials. No published standard exists
Compare
Your own Phase 3 starts in the second quarter of 2028, by your plan
Rival primary completion comes first, by one to three months
So what
A person decides
Could we see their data before locking our design? Does that change the comparator?
06 · Decision dates
PDUFA date meaning: a goal measured from the 60-day filing date, which FDA can beat, miss or answer with a refusal
In shortThe PDUFA date, named for the Prescription Drug User Fee Act, is FDA's performance goal for one review. It is 10 or 6 months from the 60-day filing date for a new molecular entity or an original biologic. Meeting it means FDA acted, and the action can be a complete response letter, which says FDA cannot approve the application yet. FDA began publishing those letters in 2025 and paused prompt release of new ones in April 2026. A voucher pilot aims for reviews far shorter than the standard clock.
The commitment letter states the goals as portfolio targets: review and act on 90 percent of standard new molecular entity applications and original biologics applications "within 10 months of the 60-day filing date", and 90 percent of priority ones within 6 months.8 A new molecular entity is, broadly, a drug whose active part FDA has not approved before.26 The filing date marks the end of the 60 days FDA has to decide whether an application can be filed.27
Worked through with an invented filing: an application submitted on January 15, 2026 reaches its 60-day filing date on March 16, 2026. The standard goal is then January 16, 2027, and the priority goal is September 16, 2026.
Goal date = submission date + 60 days + 10 months (standard) or 6 months (priority)
In practice the date usually becomes public when the company says so, since FDA's rule keeps an unapproved application's existence confidential unless it is already public.3 A proposed change to that rule is below. Keep the wording: "target action date" is a company's statement of an agency goal, and it can surprise you in two ways: the action can be a complete response letter, and it can come months early.
About one in four new applications still gets a complete response on the first cycle
First-cycle complete response rate for original NDAs and BLAs, by receipt cohort
47%FY2008
22%FY2018
37%FY2020
27%FY2024
Source28 · FDA's paper says approximately 27% for FY2024 in two passages and 28% in one. Average 33.7% over FY2008 to FY2024, range 22% to 50%, as of June 1, 2026. Refused applications excluded.
Show the numbers
Period
Value
FY2008
47%
FY2018
22%
FY2020
37%
FY2024
27%
What changed on rival decision calendars from 2025 to 2027
Review letters went public in 2025 and stalled in 2026, and FDA can review some drugs in months
Jul 10, 2025First review letters go public
FDA posts more than 200 complete response letters for applications later approved.
Sep 4, 2025Letters on unapproved drugs
FDA posts 89 more and says future ones will follow promptly after issue, with company names.
Oct 16, 2025Voucher awards begin
National priority voucher pilot: a target of 1 to 2 months, against 6 months or more.
Apr 2026Prompt release paused
HHS says the effort was temporarily paused after a citizen petition. Letters appear again in July.
Aug 26, 2026An approval far ahead of its goal
An FDA notice records a cancer approval about 6.5 months before the goal date.
Oct 16, 2026Draft PDUFA VIII comments close
The draft of the next user-fee agreement covers fiscal 2028 to 2032 and is due to Congress by January 15, 2027. We found no report of it reaching Congress.
A filing acceptance no longer tells you how long you have, since FDA can act far ahead of the goal date.
A rival's failed review may be readable in FDA's words, redacted, in the openFDA dataset, where earlier you usually had only the company's account.17 Do not rely on its timing, though. A spokesperson for the US health department (HHS) told a trade publication the effort was temporarily paused from April 2026 after a citizen petition, and new letters appeared again that July.31,34 On November 3, 2026 the dataset held 458 letters, last updated August 13, 2026, the newest dated August 7.35
The release rule may change again. A proposed rule to widen the Commissioner's discretion to release such letters, and to drop the presumption that an application's existence is confidential, was scheduled for October 2026; we found none published by November 3.36
A voucher in a rival's hands is a date risk worth its own row, since FDA's page lists award rounds through April 24, 2026.30
Europe works differently. EMA publishes a monthly list of medicines the Committee for Medicinal Products for Human Use is evaluating, with the common name of the active substance and a short summary of the indication, and it adds separate files for extensions of indication.16 The October 2026 list was first published on October 9, 2026.16 A company's name may not be on it, so a tracker must match by substance.
07 · Top-line results
What top-line results and congress abstracts leave out, and how to read a rival's clinical trial results
In shortA top-line release is evidence that a statement was made. When a release comes at least 90 days before the paper, the median gap is about eight months, and the release may be the only account there is. Keep the exact sentence, note what it omits, and let the abstract and the paper correct it. Rival tolerability numbers are clinical trial results and belong in the same table, read with the same care.
246 days
median lead of a press release over the journal paper, among the 17% of 988 drug trials in high-impact journals released at least 90 days early. Industry funding was the strongest predictor.9
Purohit et al., 2023
47%
of 70 press releases on two-arm trials carried spin, wording that emphasizes benefit. Findings were overestimated in 27%. All were indexed in one research news database.12
Yavchitz et al., 2012
37%
of 307,028 meeting abstracts reached full publication in the studies reviewed, across all kinds of research.15
Scherer et al., Cochrane, 2018
Trials reach print more often than other abstracts, yet about a third have not after ten years
Estimated share of meeting abstracts published in full
Randomized and controlled trials, by 10 years68.7%
A form to fill in when a rival reports: claim, source, what is missing
Field
What to record
Why
Exact sentence
Copied word for word, with date and link
"Met its primary endpoint" fits a large effect and a trivial one
Interim or final
As the source says, and the follow-up time
An interim result can shift at the final analysis
Effect and interval
Median in each treatment group (each arm), hazard ratio, confidence interval (the range around the estimate), or "not given"
The blanks are information too
Trial tolerability
The trial's reported rates of severe side effects on each arm, or "not given"
Part of the trial's result, and a bar your own trial may be judged against
Population and comparator
Line of therapy (first treatment or later), any test used to select patients (biomarker), control arm (the comparison group)
Two trials are comparable only as far as these match
Comparing two rival trials side by side is a judgment and should say so
Two trials in adjacent columns invite a head-to-head reading, yet each ran on its own patients with its own control group. Take the fictional abstract later in this guide: median progression-free survival (the time until the disease worsened or the patient died37) of 11.0 against 7.2 months, a hazard ratio of 0.64. A hazard ratio below 1 means fewer events on the new treatment, and within that trial the gap is 3.8 months, our arithmetic.
Set beside another trial with different patients, a different control arm and different follow-up, those numbers show a difference in trials as much as a difference in drugs. Copy the numbers exactly, say so whenever you compute a number the source did not report, and label any cross-trial view as your own reading.
08 · The legal line
Public sources and insider information: what a competitive intelligence team may read, and what it must walk away from
In shortReading what a rival has published is lawful and is the basis of the profession. Getting information by misrepresentation, or from someone breaking a duty of confidence, is not. Unpublished trial results of a listed company are also inside information, and a team that receives them has a securities problem as well as an ethics one. Write the limit down. Ask your counsel about your own case.
The profession's code, from the Strategic Consortium of Intelligence Professionals, is a set of guidelines for setting your own standards. Its seven principles include complying with all applicable laws and disclosing "one's identity and organization" before all interviews.38 Law sits underneath it. US trade secret law treats theft, bribery, misrepresentation, breach of a duty to maintain secrecy and inducing such a breach as improper means, and it carves out reverse engineering, independent derivation and other lawful means.5 Theft of a trade secret is a federal crime.39
Securities law adds a second limit, because a trial result can move a share price. Under US Regulation FD, when a listed company gives material nonpublic information (important news not yet released) to certain market participants, it must make that information public, at once if the disclosure was intentional and promptly if it was not; people who owe a duty of confidence or who agree to confidentiality are excluded.13 That is one reason news comes out on public calls and in filings.
In the EU, inside information is information of a precise nature, not yet public, that would be likely to significantly affect the price of a financial instrument, and unlawful disclosure is banned along with insider dealing.40
Two US cases show how close this sits. In January 2026 the US Securities and Exchange Commission (SEC) charged a biostatistics consultant who, it alleges, learned of positive trial results through his work and bought the sponsor's shares before the announcement; the release reports charges only.6In 2024 a jury found against a biopharma business development head who, using confidential news about his own employer's sale, bought options in a different company in the same field. The court upheld the verdict on September 9, 2024, with a civil penalty of $321,197.40.41 He has since taken it to the Ninth Circuit, a federal appeals court; we found no ruling by November 3, 2026, reading a news listing rather than the docket.42Your watch list names companies whose shares your colleagues could trade.
The risk rises as a source moves from a public page to a person with a duty
Where each way of learning something tends to sit, by legal question
LowWatchHighStop
Trade secretInside informationCompetition lawProfessional ethicsPublic registry or agency databaseLowLowLowLowCompany website, public investor callLowLowLowLowLicensed database of public factsLowLowLowLowConference talk, after the embargo liftsLowLowLowLowHallway talk with a rival's staffWatchWatchHighWatchInterview, identity not disclosedHighWatchWatchStopTrial site staff describing unreported dataHighStopLowStopNew hire from a rival, sharing what they recallStopHighWatchHighDirect swap of plans with a rivalWatchWatchStopHigh
Our reading of the sources38,5,13,43 · Our judgment, not legal advice. Your policy and your counsel decide.
Show the numbers
Trade secret
Inside information
Competition law
Professional ethics
Public registry or agency database
Low
Low
Low
Low
Company website, public investor call
Low
Low
Low
Low
Licensed database of public facts
Low
Low
Low
Low
Conference talk, after the embargo lifts
Low
Low
Low
Low
Hallway talk with a rival's staff
Watch
Watch
High
Watch
Interview, identity not disclosed
High
Watch
Watch
Stop
Trial site staff describing unreported data
High
Stop
Low
Stop
New hire from a rival, sharing what they recall
Stop
High
Watch
High
Direct swap of plans with a rival
Watch
Watch
Stop
High
Competition law: why you read about rivals and never talk to them about plans
The US antitrust agencies withdrew their guidelines on collaboration among competitors on December 11, 2024 and pointed businesses to statutes and case law.44 They asked for comment on possible new guidance on February 23, 2026, and we found none issued by November 3, 2026.45
A 2018 staff note from the Federal Trade Commission (FTC) on pre-merger diligence still gives a plain list of what is sensitive between competitors, "current and future price information, strategic plans, and costs", and says clean teams, the select people allowed to see a counterparty's sensitive data in a deal, should not include people responsible for competitive planning, pricing or strategy.43 That note concerns merger talks, and the logic carries over: public reading is one-way. A conversation with a rival about what either of you plans is a different act.
The written limit a CI policy should carry
A closed list of source families the team may read, with paid sources named.
A ban on pretexting (posing as someone else to get information), undisclosed interviews, and asking site staff or former employees about unreported data.
A named lawyer or compliance officer who hears any unexpected disclosure the same day, and a rule to stop, and to neither forward nor circulate it.
Controlled readership for your own plan dates, which may be inside information about your own company.
The source kept with every claim, which is what makes the other four provable a year later.
09 · Competing for sites
Competitive enrollment: a rival's site list can tell you which of your shortlisted hospitals are about to split their patients
In shortTwo trials recruiting the same patients at one hospital compete for a limited pool. Registries list facilities and each site's status, and the status has a 30-day update clock. Setting a rival's list against your shortlist is cheap, and few teams do it after the site list is approved.
Nearly half of trial sites fall short on enrollment
48 in 100
investigative sites under-enrolled in the 2012 Tufts study of about 16,000 sites. That 48 includes the 11 that enrolled no one
Source46 · Old data, a widely quoted figure. It does not say how much of the shortfall comes from competing trials.
Show the numbers
Measure
Value
investigative sites under-enrolled in the 2012 Tufts study of about 16,000 sites. That 48 includes the 11 that enrolled no one
48 of 100
A 2014 cost review for the US health department put the barrier plainly: "There is competition for limited patient pools for certain conditions, such as rare cancers and multiple sclerosis", and sites "are often selected based on the location of investigators rather than patients".47 No published figure says how much of a site's shortfall comes from a rival trial. Your own data can show it: compare enrollment at shortlisted sites where a rival opened with those where none did.
Our count: how often psoriasis trial sites are shared between sponsors
More than one psoriasis trial site in eight also ran a rival company's trial
Industry Phase 2 and Phase 3 psoriasis trials starting 2023 to 2025: 90 trials, 2,532 distinct facility names
All facilities listed2,532
In two or more of the trials749
In trials of two or more sponsor companies337
In trials of three or more sponsor companies125
Source1 · Our count, exact name and city match after lower-casing. We merged lead sponsor names that plainly belong to one company (345 and 126 before merging), and other affiliates may remain. Spelling differences hide many site matches. Not all overlaps ran at the same time. Trials are those the registry returns for psoriasis, Phase 2 including Phase 1/2.
Show the numbers
Facility names
Count
All facilities listed
2,532
In two or more of the trials
749
In trials of two or more sponsor companies
337
In trials of three or more sponsor companies
125
Late-stage trials are wide enough for the check to matter. Industry Phase 3 trials that started in 2024, counting combined Phase 2/3, listed a median of 19 sites, a quarter listed 74 or more, and 46% ran in two or more countries, on the same count.1 Those numbers come from public records and would take an analyst hours per trial to compare by hand.
10 · Common errors
Ten errors that make a pharma competitive landscape wrong, and why careful people make them
In shortMost errors come from three habits: reading a plan as a fact, losing the sentence a claim came from, and checking too rarely. Those habits grow from hand work under time pressure, and no regulator inspects this work, so nothing catches them.
A difference in patients looks like a difference in drugs
Label it, with populations beside the numbers
A stale site list
A rival opens at your hospital after approval of your list
Re-compare until the site list closes
Fix the frequent, costly errors first: estimates and lost sources
What it costs when it does →
Build a check
Fix first
Live with it
Automate it
Estimate read as factLost sourceMissed registryGoal as approvalOne event as threeStale site list
How often it happens →
Illustrative · replace with your own numbers · Our placement, for discussion. Score your last ten briefs and move the points.
Show the numbers
Item
How often it happens (0–1)
What it costs when it does (0–1)
Estimate read as fact
0.72
0.71
Lost source
0.62
0.54
Missed registry
0.28
0.80
Goal as approval
0.22
0.62
One event as three
0.75
0.20
Stale site list
0.45
0.33
11 · Volume and trend
Why hand-built drug landscapes are breaking: about 23,000 drugs in development, and CI leaders who expect no more people to do the reading
In shortThe pipeline is large and may have stopped growing, depending on who counts. Most assets on any board will never reach approval, so a board needs pruning as well as adding. Most CI leaders expect flat or lower budgets and headcount. No public figure sizes the pharma CI market itself.
22,940
drugs in the global R&D pipeline at the start of 2026, down 3.92%. Citeline, a pharma data company, calls this year's data possibly anomalous after data changes and the trend probably flat.48
Chemistry & Industry, on Citeline
7.9%
of Phase I candidates reached approval, 2011 to 2020, with an average of 10.5 years from Phase I to approval.49
BIO, Informa, QLS
$573M
one firm's estimate of competitive intelligence software across five end-use industries, health care among them, in 2025, forecast at $1,146 million by 2031.50
Ken Research
Of 100 Phase I rivals on a board, about 8 reach approval
Enter Phase I100
Reach Phase II52
Reach Phase III15
Reach filing8.7
Approved7.9
Source49 · Published transition rates 52.0%, 28.9%, 57.8% and 90.6%, 2011 to 2020; the running figures are our arithmetic. Rates vary widely by disease.
Show the numbers
Stage
Count
Enter Phase I
100
Reach Phase II
52
Reach Phase III
15
Reach filing
8.7
Approved
7.9
Read that funnel as a warning about attention. Phase II is the largest hurdle, with 28.9% moving on.49 A board that gives every early rival a row will fill with assets that quietly stop, and sponsors have a 30-day duty to report a stopped status only for trials the rule covers.2,11
The other half of the problem is people and budget. Trinity Life Sciences reports that "the clinical-stage pipeline of new medicines more than doubled between 2019 and 2024", citing PMPRB and ISPOR 2025 data, and that "most pharma CI leaders expect flat or lower budgets and headcount over the next 12 months", citing TGaS Advisors surveys.51 That doubling uses a different count from Citeline's flat total, so treat neither as settled. Both point the same way for a CI team: more to read, and no more people to read it.
12 · AI and its limits
Pharma competitive intelligence with AI: what regulators say, and why outcome numbers still need a person
In shortComparing records, copying sentences and checking databases are repeatable, so they suit software. Measured accuracy is good on background facts and uneven on outcome numbers. Deciding what a change means is a judgment. The main AI rules for drug development were written for other uses, which leaves your own policy and evidence to carry the weight.
A useful test for what to automate: would a second competent person, given the same sources, produce the same output? Comparing two versions of a record passes. So does copying a hazard ratio from a table, if the copy is checked. Deciding whether a rival's Phase 3 start should change your own trial fails it, and the disagreement between two good people is the reason to have them.
Language models read trial background well and outcome numbers unevenly
Share of extractions with no error, lowest and highest of three models, in one sepsis guideline evaluation
Lowest modelHighest model
Background data81.6%92.4%
Outcome data27.8%80.7%
Source52 · Mid-2020s models on trials behind five clinical questions, compared with manual extraction. Missing or wrong values made up most errors; invented output was relatively uncommon. Newer models may differ: test yours on your own sources.
Show the numbers
Lowest model
Highest model
Background data
81.6%
92.4%
Outcome data
27.8%
80.7%
Where the AI rules stand for competitive intelligence, as of November 3, 2026
Text
Status
What it means here
FDA draft guidance on AI for regulatory decision-making
It says it does not address AI "when used for operational efficiencies" that do not affect safety, quality or study reliability. A landscape brief is internal planning
EU AI Act
In force; the AI Omnibus, an amending law effective July 27, 2026, moved Annex III rules to December 2, 202754
Annex III lists high-risk uses. Reading public trial records is not an Annex III use as we read the list. Ask your counsel, and check again if you feed the output into hiring or similar decisions
Draft EU GMP Annex 22
Draft; consultation closed October 7, 2025; not on the EudraLex Volume 4 page55
Written for good manufacturing practice (GMP), the quality rules for making drugs. Competitive reading is outside it, so it neither restricts this work nor lends it any standing
GxP (the good-practice rules), 21 CFR Part 11 (FDA's electronic records rule)
Apply to regulated records
A CI brief is usually not one. If yours feeds a submission, that use carries its own controls, and your quality team decides
Four limits a pipeline-reading system should state out loud
It reads public sources only, and it cannot know what a rival has not published. A quiet month on a board may mean nothing happened or nothing was said.
Copying accuracy needs a test on your own material, since one evaluation on sepsis trials does not transfer to oncology abstracts.
A confidence score is the system's view of itself. Keep a person on anything that will change a decision.
A forecast stays labeled as one, and a model's estimate of a rival's readout should never be written as a date.
13 · How teams do it today
Who builds a competitive landscape in pharma, where the analyst's week goes and how teams resource it
In shortA CI lead and a few analysts read five source families, build a deck, and take it to program teams monthly or quarterly. Most of the hours go to finding and checking. Teams buy a database, outsource to an agency, or read by hand, and most combine them.
Five colleagues around one rival move, and the question each one asks
CI
Competitive intelligence lead
Owns the watch lists, the sources and the policy. Signs what is sent.
"I want Monday for deciding what it means, and less of it spent finding out what happened."
AN
CI analyst
Reads the sources, confirms changes and drafts the view.
"If it isn't sourced, it isn't in the brief."
PL
Program lead
Reads and acts: design, comparator, timing.
"Tell me who reads out before us, and when."
CO
Clinical operations
Runs feasibility and site selection.
"Which of our shortlisted sites is a rival about to open?"
LC
Legal and compliance
Sets the limit and hears anything that crosses it.
"Where did this come from, and who has seen it?"
A rival's move passes through four hand-offs before a program team hears of it
1Rival acts
A first patient, a site, a date.
Rival sponsorDay 0
2It surfaces
A record, a page, a call.
Public sourceDays to weeks
3An analyst finds it
At the next read, not the next day.
CI analystNext refresh
4It goes in the deck
With a line on why it matters.
CI analyst, CI leadHours to days
5The team hears
At the next review, or by email.
Program leadOften the next meeting
Illustrative · replace with your own numbers · A typical pattern, unmeasured. Time your own last ten moves.
Show the numbers
Step
What happens
Who
Time
Rival acts
A first patient, a site, a date.
Rival sponsor
Day 0
It surfaces
A record, a page, a call.
Public source
Days to weeks
An analyst finds it
At the next read, not the next day.
CI analyst
Next refresh
It goes in the deck
With a line on why it matters.
CI analyst, CI lead
Hours to days
The team hears
At the next review, or by email.
Program lead
Often the next meeting
Where a landscape refresh's hours go
Finding and checking take far more hours than writing
One estimated refresh across five watch lists, 32 working hours
Checking trial registries for record changes10 h
Reading releases, pipeline pages and calls7 h
Pulling abstract numbers into a table5 h
Writing, sourcing and sending each brief4 h
Checking US, EU and Japan agency sites3 h
Updating phases and dates in the deck3 h
Illustrative · replace with your own numbers · An estimate. No public benchmark of analyst hours exists. Replace it with one week of your own time.
Show the numbers
Item
Value
Checking trial registries for record changes
10 h
Reading releases, pipeline pages and calls
7 h
Pulling abstract numbers into a table
5 h
Writing, sourcing and sending each brief
4 h
Checking US, EU and Japan agency sites
3 h
Updating phases and dates in the deck
3 h
Database, agency or reading in house: how pharma teams resource pipeline tracking
Way of working
What you get
What you still do
Commercial pipeline database
Standardized assets, mechanisms, phases and links across a whole field, by curators
Decide what it means for your program. Check freshness and trace a claim to its source
Agency or consultants
Depth on a question, congress coverage, extra hands
Hold them to your written limit. The code asks practitioners to promote it with third-party contractors38
Reading by hand, with alerts
Control, low cost, deep knowledge of one field
All of it, and it stops when the analyst is away
Page and registry monitors
A notice that something changed
Reading, merging, judging and writing
Reading software with sign-off
Weekly reads against your watch list, kept versions and drafted briefs
Set the rules, confirm what is significant, and approve what goes out
Wages give a rough floor for the cost of the reading. The broad US occupation closest to this work, Market Research Analysts and Marketing Specialists, had a median wage of $37.87 an hour in 2025, with about 952,700 people employed, which covers far more than pharma.56 A specialist oncology analyst earns more than that, so use your own loaded cost.
Part B · See it working
One Monday through Botminds Competitive Pipeline Tracking, from the watch run to a sent brief
Part A described the work without naming a product. This part shows how Botminds does it, for a fictional sponsor with five watch lists. Every company, medicine, target, trial, registry number, person, date and figure on these screens is sample data, and none describes a real program. The screens are set on Monday, October 5, 2026.
14 · One Monday, start to finish
ORX-23 moves to Phase 3 on the psoriasis race board, with its first patient dosed October 3 and both sources one click away
In shortThis is the example from the top of the page, inside the product. Before anyone is at a desk, six specialist agents, pieces of software that each hold one job, read the public sources for five watch lists. Lena Ortiz, the competitive intelligence lead, opens a board that has already moved, checks each move against its source and decides what matters. The product reads public sources, and people decide what it means.
1
Four watchers read every source before anyone is in
At 6:00 am the weekly run starts on 5 watch lists and 49 assets. The Registry watcher checks 612 trial records and finds 18 changed. The News watcher reads 38 releases and pipeline pages and finds 9 relevant. The Abstract reader goes through 212 abstracts and matches one late-breaker, an abstract submitted after a congress's regular deadline.14 The Approval watcher finds one new US approval.
The Change detector merges 35 findings into 28 changes, 6 of them significant, and the run ends at 6:14 am across 1,284 sources.
Monday's run. The board is still as it stood last week while the watchers run, one line at a time above the lanes.
2
The race board answers who is ahead of IM-7740
Each indication gets a lane. Every rival sits on its phase and your own program is the dark marker. Rows sort by phase and then by next readout, so anyone ahead of you reads from the top down.
In moderate-to-severe plaque psoriasis the header reads 5 ahead of IM-7740 and 6 of 7 read out before us. Beside the lanes, this week's three moves are listed with their sources.
The race board. Dashed arrows show where ORX-23 and SLN-1723 came from. A date in amber has moved.
3
One click shows ORX-23's move with the old and new text
Selecting ORX-23 opens its stage path, the move and a countdown: 18 months to primary completion in March 2028. A note says it shares IM-7740's mechanism, and its Phase 3 data are due before your own Phase 3 is planned to start, in the second quarter of 2028.
Both sources sit below: the registry change from version 2 to version 3, and the pipeline page capture. A reader can open either at the exact passage.
One move, with its sources. The sample compresses the calendar. On the real registry a submission takes time to post (first postings took a median of 7 days, in our count), so an edit about a Saturday start would usually appear later.1
4
A readout moved a month earlier, in one sentence on a call
On an investor call on October 1, Quillon Therapeutics said enrollment finished early, so it now expects top-line data from QUILL-PSO-1 in December, ahead of its earlier guidance of January 2027. QLN-2319's countdown turns amber at 71 days, and the move is listed.
That sentence is the only public source for the new date. The product keeps it word for word, and the date stays labeled as guidance from the sponsor.
A guided date moves. The readout is 9 months before IM-7740's. The source type on this sample reads "Earnings call".
15 · An approval and a new Phase 3
On NX-4127's board: a rival approval that changes the comparator, a first-line Phase 3 and 38 sites on your shortlist
In shortThe sponsor's second watch list follows an invented cancer target, ZK4. Three of this week's 11 changes matter to NX-4127, a Phase 2 drug in biliary tract cancer. First-line means a patient's first treatment, and second-line the one after it. The product shows what changed and proposes why it matters. Lena confirms, and a named analyst stays responsible for the view.
Lanes for one program. Previously treated metastatic biliary cancer: 2 ahead of NX-4127, 4 of 6 read out before us. VNT-224 moved from Filed to Approved, and SLN-0582 moved to Phase 3 with SOLSTICE-BIL, 540 patients.
Before and after, field by field, for the VNT-224 approval
The change feed compares this morning's capture with last Monday's. Status moved from Under review (priority) to Approved in the United States; the indication and a label limited to test-selected patients, with overall survival (the time until death from any cause37) of 12.4 against 6.8 months, appear for the first time. The approval letter and the sponsor's release sit beside the change with the passage marked. The Change detector writes two sentences on why it matters, and Lena has confirmed it.
The change feed. Overall survival here is a trial result copied from the sample's sources. The Abstract reader copies numbers and never computes them.
A mechanism and phase map of 14 watched ZK4 assets
The landscape places each asset by mechanism (how the drug works) against phase, with your own program in dark blue. This week: 11 changes, 3 significant. Rows below carry the lead indication, last change and a threat rating for your program.
The landscape. A view of the same records as the race board, sorted by how the drugs work.
The readout calendar: 59 dates, each with its source
The readouts page holds every expected readout, decision and data release across all boards, split by whether a rival falls before or after your own date. Three rival readouts fall in the next 90 days. Each row names its source type, so a congress session and a guided month look different.
Readouts. Full CORAL-301 data on October 22, week-52 X-ray data on November 14, and QUILL-PSO-1 top-line in December lead the fourth quarter.
A rival's detail. SLN-0582 reads out second-line expansion data six months before NX-4127.
The asset profile. Four changes in 12 weeks, one of them significant, and three trials checked every Monday.
16 · The brief
A one-page brief for the ZK4-B team: 14 claims, each linked to its passage, and nothing sent until Lena approves
In shortThe Brief writer drafts one page per program team: a three-line summary, what changed, what it means with an owner for each action, and what to watch next. The checks sit beside it. A named analyst approves, and the name, the time and the sent version are kept.
1
The brief sits beside its sources
The week 40 ZK4 brief says three things up top: VNT-224 is approved, SLN-0582 is in Phase 3 in the first-line setting where NX-4127 plans its own Phase 3, and WXC-907 met its Phase 3 endpoint (progression-free survival hazard ratio 0.64).
Under each change is a "so what": VNT-224 becomes the likely comparator for any second-line trial of NX-4127, and 38 of SLN-0582's likely sites are on your feasibility shortlist. Priya Ranvelle is to review the second-line Phase 3 design before the November 2 governance meeting, and Jonas Harbeck is to check the 38 shared sites before site selection closes on October 30.
The brief and its sources. Click any number in the brief and its passage opens.
2
Approval names what is still open
Before sending, the screen says 2 changes still need Lena's confirmation, SLN-0582 and PLH-12, and that approving confirms them as written. It lists the 14 readers, from the program lead to clinical operations, regulatory and market access, and how the brief goes out.
Program leads read and ask questions. Only the CI lead or analyst edits and sends.
Approve and send. Your approval is recorded with your name and the time, and the sent version is kept.
3
Sent, with its trail
The activity list records each step: the Change detector found 11 changes, the Brief writer drafted 14 claims, Lena confirmed 9 of 11, then the two others with the brief, and sent it to 14 people at 9:09 am.
Sent, on the record. Five briefs a week come through this same step, one per program team.
Every brief, every week. Earlier that morning Sam Patel approved and sent the Gastric and Lipids briefs. The sample shows 36 of 36 claims sourced this week.
17 · Who reads, who signs
Six reading jobs, one person who decides, the public sources in and the sourced brief out
In shortEach agent holds one narrow job and has a line it never crosses. A person confirms what is significant and approves what is sent. Watch lists, schedule, rules and sources are settings, and each change is saved as a new version on the audit trail.
The one job each pipeline tracking agent holds, and the line it never crosses
Registry watcher
Compares each watched trial record with its last captured version on the US, EU, Japan and China registries: status, phase, start, enrollment, dates, arms and sites, with the exact text before and after.
Never infers a status the record does not state.
News watcher
Reads sponsor press releases, pipeline pages and investor call transcripts, and keeps the exact sentence behind each claim.
Never uses a non-public source.
Abstract reader
Pulls design, population, efficacy results and the trial's reported tolerability results from congress abstracts into one table, and flags interim data.
Never computes a number. It copies them.
Approval watcher
Checks US, EU and Japan agency databases for approvals, filing acceptances and label changes on watched assets.
Never paraphrases an indication.
Change detector
Merges findings into one change per real event, proposes significance from your rules, explains why it matters and updates the board.
Never marks a significant change final. An analyst confirms it, and anything below 85% confidence goes to review.
Brief writer
Drafts the one-page brief for each team and links every claim to its passage.
Never states a forecast as fact, or sends anything.
The limit, stated plainly. The product reads public sources only. It contacts no one, logs in as no one and holds no rival's non-public data. It cannot know what a rival has not said, and it cannot judge whether something a colleague heard in a hallway is inside information. Your policy and your counsel decide that, and nothing outside the source list enters the system. What a change means for your program is a person's call.
What goes in and what comes out of a weekly watch run
Public sources
Trial registries in the US, EU, Japan and China
Press releases and pipeline pages
Investor call transcripts
Congress abstracts and programs
Agency approval databases in the US, EU and Japan
From your company
Your approved development plan dates, for program teams only
Your site feasibility shortlist
Agents read, compare, merge and draftEvery claim tied to the public passage behind it
An analyst confirms and approves
Each source version is kept
Outputs
A race board per indication
A readout calendar with a source for every date
A weekly one-page brief per program team
A change log you can export
On the record
Run history, confirmations, edits and approvals
The sent version of each brief
Retained for 7 years on the audit trail
Where the sample's changes came from over 12 weeks, and the time they took
The dashboard reports the sample's last 12 weeks: 280 changes across 49 watched assets, 45 significant, 46 briefs sent. The by-hand baseline on this screen, 4 days to refresh and 9 days for a move to reach the team, is the sample's own 2025 workload. It is an illustration, and no public benchmark exists.
Half the sample's changes came from trial registries
4source types
Trial registries52%
Press releases and pipeline pages23%
Congress abstracts17%
Agency approvals8%
Fictional example from this guide · Sample data on the dashboard below, last 12 weeks.
Show the numbers
Part
Value
Trial registries
52%
Press releases and pipeline pages
23%
Congress abstracts
17%
Agency approvals
8%
The dashboard. The event-to-team median on this sample is 3.2 days. The design target is 3 days, the same day for approvals.
Your watch lists, your rules: settings a CI lead changes without a release
Watch lists carry their assets, program team, readers and approver. Runs go weekly, twice a week or daily. Delivery is on approval or at noon on Monday, and never before an analyst approves. Same-day alerts cover approvals and major readouts. The significance rules are approvals, filings and label changes; major readouts; phase advances; new trials in your indication; trials stopped; a primary completion date moving more than three months; and sites in your shortlist countries.
Watch lists and schedule. Each change is saved as a new version on the audit trail.
What counts as significant. Approver, reader and admin roles keep editing and sending with the CI team.
Systems a competitive pipeline tracking team plans around
Public registries and agency sitesRead directly, each version kept
Your development planYour own dates, for program teams only
Feasibility tool or trackerYour site shortlist
Licensed pipeline databaseUsed alongside it, within your license
Email and team workspaceWhere the approved brief goes
Identity and audit systemsRoles, two-person approval (maker-checker) and audit export
Botminds is SOC 2 Type II audited and manages information security to ISO 27001. A competitive brief is usually not a GxP record. If yours feeds a regulated process, the controls here support your compliance, and your quality team decides what that use requires.
Part C · Are you ready to automate?
Deciding on pipeline tracking software: what a late landscape costs, what automation returns and how to prove it on your own watch list
You run competitive intelligence, or you lead a program that depends on it, or you must sign off how it is done. This part is written for you: what the work costs today, what automating could return, whether your team is ready, and what to ask any vendor, including us.
18 · What a late landscape costs
A trial designed against yesterday's comparator: the costs of hearing about a rival's move late
In shortAnalyst hours are the visible cost and the smallest. The large costs are decisions made on stale facts: a design that must change, a site list that must be redone, days lost on a trial. Published figures give you the price of a day. You can find your own lag in a week.
$40,000
estimated direct cost of a day of a Phase II or III trial.57
Tufts CSDD, 2024
$500,000
approximate lost sales for a day of delay in the journal article. Tufts' white paper on the same dataset says about $800,000.57,58
Tufts CSDD, 2024
48 in 100
sites under-enrolled in Tufts' 2012 study, including those that enrolled no one.46
Applied Clinical Trials
A refresh could fall from about 32 hours to 36 minutes, with review included
One refresh across five watch lists. Today's hours are an estimate; the automated hours are a design target
By hand (estimate)With agents (design target)
Checking trial registries10 hours0.05 hours
Reading releases, pages and calls7 hours0.05 hours
Pulling abstract numbers5 hours0.05 hours
Writing, sourcing and sending briefs4 hours0.35 hours
Checking agency sites3 hours0.05 hours
Updating phases and dates3 hours0.05 hours
Illustrative · replace with your own numbers · Design targets from the solution, not measured results. Replace them with your own measurement. Time spent on what it means is not on this chart, and should grow.
Show the numbers
By hand (estimate)
With agents (design target)
Checking trial registries
10 hours
0.05 hours
Reading releases, pages and calls
7 hours
0.05 hours
Pulling abstract numbers
5 hours
0.05 hours
Writing, sourcing and sending briefs
4 hours
0.35 hours
Checking agency sites
3 hours
0.05 hours
Updating phases and dates
3 hours
0.05 hours
What nobody publishes. We found no public figure for how late a typical team hears of a rival's move, how many hours a refresh takes, how often a landscape claim is wrong, or what a missed move cost anyone. The vendor figures we saw came without a dataset. Measure your own.
Ten past moves, ten claims and one site list: how to audit your own landscape
Cost
Where it hides
How to find your number in a week
Lag to the team
Between a public date and the next review meeting
List 10 moves. Compare the source's date with the day the program team heard
Analyst hours
Registry checks spread across the week
Ask analysts to log one refresh, by source family
Unsourced claims
Slides copied forward from earlier decks
Pick 10 claims from the last deck. Time how long tracing each takes, and count those you cannot trace
Stale dates
The readout spreadsheet
Check 20 dates against today's record. Count the differences
Site overlap
An approved list nobody compared again
Match your last shortlist against rival records' facilities
Design changes after the fact
Protocol amendments that cite a new standard of care
Ask each program lead for one example, with the date it could first have been known
Losses from late rival news that stay off the spreadsheet
Trust in the functionA program lead who heard it first at a congress stops reading your brief.
Sharper questionsAn analyst who spends Monday finding facts has no time to ask what they imply.
An answer in the roomGovernance meetings where nobody can say which sentence a claim came from.
Knowledge that leavesWhen an analyst moves on, so does the memory of what each rival said last year.
A clean recordBeing able to show counsel, a year later, exactly where a statement came from.
19 · Your return
What sourced weekly tracking returns: hours you can count and trial days that carry most of the value
In shortOn realistic inputs, saved analyst time alone may not pay for software, especially if you move from monthly to weekly reading. The case rests on decisions made sooner. The calculator shows both and tells you how many trial days the software has to save to pay for itself.
Four levers for pipeline tracking, each with its formula
Reading
Fewer hours finding facts
Records compared and sentences kept on a schedule.
Formulas: hours today = lists × refreshes × hours. Hours with review = lists × 52 × review hours. Time saved = (today − with review) × hourly cost, never below zero. Trial days valued = days × cost per day. Days that pay = (cost − time saved) ÷ cost per day.
The $40,000 is Tufts' direct cost estimate for Phase II and III.57 The 6.4 hours is 32 hours across five lists, an estimate. The defaults are not results, and a day saved is hard to prove, so credit only days a program lead will sign for. The broad occupation's median wage is $37.87 an hour for 2025; the $85 assumes a specialist's loaded cost.56
20 · Readiness check
Can your competitive intelligence team automate yet? Eight scored questions on watch lists, limits and approvers
In shortEight questions score 0 to 2, and the last is for reflection. The meter adds up your score as you go. A team becomes ready mostly through work outside any software: a written limit, your own dates in one place and a person with time to approve.
1
A watch list per program
Can you name the rival assets that matter to each development program, and who chose them?
Why it mattersSoftware follows a list. Someone has to own it.
A strong answer"Five lists, 49 assets, each with an owner and a date of last review."
2
A written source limit
Do you have a written policy on what the team may read and what it must walk away from?
Why it mattersLegal asks this first, and a vendor cannot write it for you.
A strong answer"A closed list of source families, reviewed by counsel, with a named person for anything unexpected."
3
Your own dates in one place
Are your own planned readouts in an approved plan that can feed a comparison?
Why it matters"Before us" means nothing without your date, and your date may be sensitive.
A strong answer"The approved development plan holds them, and readers are limited to the program team."
4
An approver with time
Is a named person able to confirm changes and approve a brief every week?
Why it mattersAutomation moves the work to judgment. If no one has time to judge, nothing is sent.
A strong answer"Lead and analyst each hold approval, about an hour on Monday."
5
A baseline
Do you know how long a refresh takes and how long a rival's move takes to reach a team?
Why it mattersWithout it, no one can say what changed.
A strong answer"We timed the last ten moves: public date against the day the team heard."
6
Readers who will act
Do program leads and clinical operations act on landscape news in their own decisions?
Why it mattersA faster brief that nobody reads returns nothing.
A strong answer"Two design changes and a site swap came from it last year."
7
Sources you may use
Have you checked licenses for paid databases, transcripts and congress materials?
Why it mattersPublic to read may still be limited by license or embargo.
A strong answer"Each paid source is listed with what we may store and share internally."
8
Someone to run the pilot
Can CI, one program team and legal give a few hours a week for ten weeks?
Why it mattersA replay of a past period takes human review to mean anything.
A strong answer"Named people, with one watch list chosen."
9
Looking ahead
For reflection only: if your whole team knew every rival's move by Monday noon, with its source, which decision would you take earlier: a comparator, a site list, a go or no-go, a partnering conversation?
What a CI team should do at a score of 0 to 6, 7 to 11 or 12 to 16
0–6
Explore
Write down the watch lists and the source limit, and time ten past moves. That work may pay for itself before you buy anything.
7–11
Ready to pilot
Replay one watch list over 13 past weeks, against what your team actually knew and when.
12–16
Ready to implement
Plan all watch lists, readers, approvers, retention and how the brief reaches each team.
21 · Questions for any vendor
Eleven questions for any pipeline tracking vendor, us included: sources, accuracy and the insider information line
In shortEleven questions, each answerable with evidence. Buyers often judge these tools on coverage in a demonstration, and a program team later judges them on whether it believed the findings. Ask with your counsel in the room, and ask us too.
A
Sources and coverage
A1
Which registries, agencies and congresses do you read, and how is each obtained?
Why it matters"Public sources" hides the gaps.
Strong answerA list by name, with how each is read.
A2
What is outside your coverage, and how would I know?
Why it mattersEvery tool has edges. WHO lists 18 primary registries.18
Strong answerA named list of what is left out, shown on the watch list.
A3
How soon after a source changes do I see it, and how do you know?
Why it mattersNothing can be fresher than the registry's own posting.2,10
Strong answerA test you can run: a record's posted date against your alert date.
B
Evidence and accuracy
B1
Can every claim and date open the passage behind it, as it read that day?
Why it mattersA live link can change or disappear.
Strong answerA captured version, with its date, one click away.
B2
Show me accuracy on outcome numbers in my therapy area.
Why it mattersPublished results vary widely by model on outcome data.52
Strong answerA test on your own abstracts, with errors counted.
B3
How do you merge one event seen in three sources?
Why it mattersDouble counting erodes trust in a list.
Strong answerA rule you can see, with the merged sources shown.
B4
How do you label an estimate, guidance, a goal date and a forecast?
Why it mattersA plan written as a fact is the most common error.
Strong answerDifferent labels, in every view and in the brief.
C
The legal line and control
C1
Do any of your sources require contact with a person, or a login a member of the public could not get?
Why it mattersThis is the question your counsel will ask.
Strong answerNo, with the list to prove it.
C2
What happens if someone uploads something non-public?
Why it mattersInside information spreads by forwarding.
Strong answerA closed source list, roles, and a record of who saw what.
C3
Who may read our own plan dates inside the system?
Why it mattersThey may be inside information about you.
Strong answerProgram team only, with the access on the audit trail.
C4
Can anything reach a reader without a named approval?
Why it mattersThis is where automation can hurt you.
Strong answerNo. The name, the time and the sent version are kept.
22 · How to start
Replay 13 past weeks of one watch list in a ten-week pilot, compare with what your team knew and decide on three numbers
In shortReplay beats a live trial, since you already know what happened. Pick one indication with real activity, freeze what your team knew at the time, run the tool over the same weeks, and score what it caught and what it invented.
Pick one watch list with at least ten rival assets and a program lead who will read the result.
Write today's answer by hand: what you knew 13 weeks ago, and when each thing reached the team.
Agree the limit with counsel: the source list, the readers, and what happens to anything unexpected.
Load your dates and rules, then replay the weeks, with an analyst confirming as they would in real use.
Decide with three numbers: moves caught, lag saved and claims that opened their source correctly.
A ten-week replay ends with a decision on three numbers
Your teamVendor
Baseline ten moves by hand
Agree source limit with counsel
Set watch list, rules and dates
Replay 13 past weeks
Analyst confirms, lead reads
Score and decide
Week 0246810
Illustrative · replace with your own numbers
Show the numbers
Activity
From
To
Baseline ten moves by hand
0
2
Agree source limit with counsel
0
2
Set watch list, rules and dates
1
4
Replay 13 past weeks
4
7
Analyst confirms, lead reads
4
8
Score and decide
8
10
Scoring the watch list replay: moves caught, lag, sourcing, numbers and false alarms
Measure
How
Why
Moves caught
Compare with your baseline list, then review any extra it found
A miss is the costly error
Lag
Source date to the day it would have reached the team, against the actual lag
This is the main value
Claims sourced correctly
Open 50 at random. Does the passage say that?
A link is worth nothing if the passage disagrees
Numbers copied correctly
Check every outcome and tolerability number in the abstract table
Changes marked significant that the analyst rejected
Too many and readers stop reading
Analyst hours
Logged for review each week
Time should move to judgment
The first three rows are the numbers you decide on. The other three show what to fix before you roll out.
Deep questions for the working session
Bring CI, a program lead, clinical operations, legal or compliance, and information security.
Licenses: which paid sources may be stored, summarized and shared internally, and for how long?
Retention: how long do you keep captured versions and sent briefs, and does your legal team agree?
Trading policy: does your insider trading policy cover rivals on a watch list? Who should be on the restricted list?
Deals: when a business development team is in talks with a rival, who decides whether that rival stays on a list, and who may read it?
Contractors: do agencies and consultants work to the same written limit?
Silence: what does your team do when a rival goes quiet, and who writes down that nothing was found?
23 · Common questions
Questions on pharma competitive intelligence, trial registries, PDUFA dates and insider information
In shortEach answer stands alone. For your own case, ask your counsel.
What is competitive pipeline tracking?
Competitive pipeline tracking is following the rival drugs that matter to your development programs, from public sources, and telling each program team what changed and what it means. It covers stage, next readout, latest clinical trial results and regulatory actions. A good tracker keeps the source passage behind every claim.
What is pharma competitive intelligence?
Pharma competitive intelligence is the legal and ethical collection and analysis of information about rival companies, to help a drug company make better decisions. The profession's code asks practitioners to comply with all laws and to disclose their identity before interviews.38 Pipeline tracking is its most regular weekly job.
How do you track competitor clinical trials?
Make a list of rival assets and trials, then compare each public record with your last saved copy on a regular schedule. Add pipeline pages, investor calls, congress programs and agency databases, since a registry alone misses programs. Keep the old and new text of every change, and label estimated dates as estimates.
How often is ClinicalTrials.gov updated by sponsors?
Sponsors must update status, site status, and actual start and completion dates within 30 calendar days of the change, and most other fields at least once every 12 months.2 Trials must be registered within 21 days of first enrollment.19 In our count, about 7 in 10 industry Phase 2 and Phase 3 trials starting in 2024 were posted before they started.1
What is the difference between primary completion date and study completion date?
The primary completion date is when the last participant gives data for the trial's main measure. The study completion date adds secondary measures and adverse events, up to the last visit.25 Estimate a readout from primary completion, since the study completion date can come a year or more later.
What does PDUFA date mean?
A PDUFA date, named for the Prescription Drug User Fee Act, is FDA's goal date for acting on one application: for a new molecular entity or original biologic, 10 months from the 60-day filing date on a standard review and 6 months on a priority review.8 Meeting it means FDA acted, and the action may be a complete response letter, which says FDA cannot approve the application yet. FDA can also act earlier; one August 2026 notice records action about 6.5 months ahead of the goal.4
What are top-line results in a clinical trial?
Top-line results are a sponsor's first short statement of whether a trial met its main goal, usually long before a journal paper. In one review of 988 drug trials, 17% had a press release at least 90 days before the paper, by a median of 246 days.9 Keep the exact sentence and note what it leaves out, such as the effect size.
Is competitive intelligence legal in pharma?
Yes, when it rests on public sources and honest conduct. US law treats misrepresentation, bribery and inducing a breach of confidence as improper means of getting a trade secret, and lawful means such as independent derivation are carved out.5 This is general information, so ask your own counsel about your policy.
Can a competitive intelligence team use insider information?
No. Unpublished results or plans of a listed company can be inside information, and using or passing them on can break securities law in the US and the EU.6,40 If someone offers such information, stop, do not forward it and tell your legal team the same day. Pipeline tracking should run on public sources, and people should decide what those sources mean.
What is competitive enrollment in clinical trials?
The phrase has two uses. Inside one trial, it means sites recruit until a total target is met, without fixed quotas. Between trials, it means two studies chasing the same patients at one hospital, which is the one a tracker can help with, since registries list facilities and each site's status.2
How is pipeline tracking software different from a pharma pipeline database?
A database gives you curated, standardized records across a whole field, and it is hard to replace for broad questions. Tracking software reads the public sources for your watch list on your schedule, keeps each version it read, sets each move against your own dates and drafts your team's view. Many teams use both, within their license terms.
Do AI rules from FDA or the EU apply to competitive intelligence?
Mostly no, because they were written for other uses. FDA's January 2025 draft guidance, still a draft, does not address AI used for operational efficiencies that do not affect patient safety, drug quality or study reliability.53 Draft EU GMP Annex 22 concerns good manufacturing practice. The EU AI Act's Annex III lists high-risk uses, and reading public trial records falls outside that list as we read it.54,55 Ask counsel about your own uses.
How accurate is AI at extracting clinical trial data?
It depends on the data. One 2026 evaluation of three models on trials behind a sepsis guideline found 81.6% to 92.4% of background extractions had no error, and 27.8% to 80.7% for outcome data, with invented output relatively uncommon.52 Test on your own material, and keep a person on numbers that will change a decision.
24 · Summary page
One page to print: how to track a rival's pipeline, where the rules stand in November 2026, and 14 terms
Print this page
In shortThe whole guide on one screen: the method, the status as of November 3, 2026, the readiness bands and the terms.
The method
Write a watch list per program, with an owner.
Write the limit: public sources, named, with a person for anything unexpected.
Compare records against your last saved copy, weekly.
Read pages, calls, congress programs and agency databases, and keep each version.
Merge one event seen in several places, and label each date's kind.
Copy results exactly, and mark interim data and cross-trial views.
A person says what it means and approves before anything is sent.
Readiness, scoring 0–2 on eight questions: 0–6 explore · 7–11 pilot · 12–16 implement.
As of November 3, 2026. In effect: 42 CFR Part 11 (21 days, 30 days, 12 months); PDUFA VII to September 30, 2027; CTIS revised rules since June 18, 2024. Unsettled: FDA review letters, published since July 2025, prompt release paused in April 2026, letters posted again that July, a rule proposal scheduled. Pilot: FDA national priority vouchers. Draft: PDUFA VIII letter, due to Congress by January 15, 2027; FDA AI guidance; EU GMP Annex 22, with Annex 11 still at January 2011. Moved: EU AI Act Annex III rules to December 2, 2027.
14 terms
Pipeline
The medicines a company is testing.
Watch list
The rivals followed for one of your programs.
Readout
When a trial's main result becomes known.
Top-line
A sponsor's first short statement of a result.
Primary completion
Last data for the trial's main measure.
Study completion
Last data for all measures, up to the last visit.
NCT number
A trial's ID on ClinicalTrials.gov.
CTIS
The EU's trial information system.
PDUFA date
FDA's goal date for acting on an application.
Complete response letter
FDA's letter saying it cannot approve yet.
Comparator
What a new drug is tested against.
Hazard ratio
Event rate in one treatment group relative to the other.
Inside information
Precise, non-public and likely to move a share price.
Spin
Wording that makes results look better than they are.
25 · Sources
Sources
Accessed November 2026. Status statements are as of November 3, 2026.
ClinicalTrials.gov public data API, version 2. Records read November 3, 2026; the counts drawn from it in this guide are our own. clinicaltrials.gov
42 CFR 11.64, when information on ClinicalTrials.gov must be updated or corrected. 2025 edition. govinfo.gov
21 CFR 314.430, availability for public disclosure of data and information in an application, paragraphs (b) and (c). law.cornell.edu
US Food and Drug Administration, approval notice in metastatic pancreatic adenocarcinoma, August 26, 2026. fda.gov
18 U.S.C. 1839, definitions, including trade secret and improper means. law.cornell.edu
US Securities and Exchange Commission, Litigation Release No. 26460. January 15, 2026. sec.gov
European Medicines Agency, Clinical Trials Information System (CTIS). Latest update entry July 9, 2026. ema.europa.eu
US Food and Drug Administration, PDUFA Reauthorization Performance Goals and Procedures, Fiscal Years 2023 Through 2027 (PDUFA VII commitment letter). fda.gov
Purohit U, Sacks CA, Raissi A, et al. Press Releases of Drug-Related Randomized Trial Results Prior to Publication in High-Impact Journals. J Gen Intern Med 2023;38:3107-3114. PubMed
42 CFR 11.22, which clinical trials the rule covers. 2025 edition. govinfo.gov
Yavchitz A, Boutron I, Bafeta A, et al. Misrepresentation of randomized controlled trials in press releases and news coverage. PLoS Med 2012;9:e1001308. PubMed
17 CFR 243.100, Regulation FD, general rule on selective disclosure. law.cornell.edu
European Hematology Association, EHA2026 Late-Breaking Abstract Submission terms, abstract embargo policy. March 2026. ehaweb.org
Scherer RW, Meerpohl JJ, Pfeifer N, et al. Full publication of results initially presented in abstracts. Cochrane Database Syst Rev 2018;11:MR000005. PubMed
European Medicines Agency, Medicines for human use under evaluation. List of October 2026, first published October 9, 2026. ema.europa.eu
US Food and Drug Administration, FDA Announces Real-Time Release of Complete Response Letters, Posts Previously Unpublished Batch of 89. September 4, 2025. fda.gov
World Health Organization, Primary Registries in the WHO Registry Network. who.int
42 CFR 11.24, when clinical trial registration information must be submitted. Code of Federal Regulations, 2025 edition. govinfo.gov
42 CFR 11.44, when results must be submitted. 2025 edition. govinfo.gov
DeVito NJ, Bacon S, Goldacre B. Compliance with legal requirement to report clinical trial results on ClinicalTrials.gov: a cohort study. Lancet 2020;395:361-369. PubMed
US Food and Drug Administration, ClinicalTrials.gov Notices of Noncompliance. Content current October 30, 2026. fda.gov
DataLookout, The one-word test for abandoned clinical trials. August 16, 2026. A company's own analysis, not peer reviewed. datalookout.com
National Library of Medicine, ClinicalTrials.gov: Updated Quality Control and Posting Procedures. NLM Technical Bulletin, January to February 2020. nlm.nih.gov
US Food and Drug Administration, Novel Drug Approvals at FDA. fda.gov
21 CFR 314.101, filing an NDA, paragraph (a). law.cornell.edu
US Food and Drug Administration, analysis of first-cycle complete response rates for original NDAs and BLAs, FY2008 to FY2024, data as of June 1, 2026. fda.gov
Holland & Knight, FDA Releases Draft GDUFA and PDUFA Commitment Letters as User Fee Reauthorization Advances. August 18, 2026. hklaw.com
US Food and Drug Administration, Commissioner's National Priority Voucher (CNPV) Pilot Program. Content current October 19, 2026. fda.gov
Applied Clinical Trials, FDA pauses real-time release of drug rejection letters to formalize policy. July 10, 2026. appliedclinicaltrialsonline.com
21 U.S.C. 379h-2(f), reauthorization of the prescription drug user fee program, transmittal to Congress not later than January 15, 2027. law.cornell.edu
US Food and Drug Administration, FDA Embraces Radical Transparency by Publishing Complete Response Letters. July 10, 2025. fda.gov
BioSpace, FDA posts new rejection letters days after confirming pause. July 13, 2026. biospace.com
openFDA, Complete Response Letters dataset. Record count and last-updated date read November 3, 2026. open.fda.gov
Office of Information and Regulatory Affairs, Unified Agenda, RIN 0910-AJ16, Proactive Disclosure of Complete Response Letters. Proposed rule stage, listed for October 2026. reginfo.gov
US Food and Drug Administration, Clinical Trial Endpoints for the Approval of Cancer Drugs and Biologics, guidance for industry. fda.gov
Strategic Consortium of Intelligence Professionals, Code of Ethics and FAQ. scip.world
Regulation (EU) No 596/2014 on market abuse, Articles 7 and 14, Official Journal text. publications.europa.eu
Proskauer, Court Upholds SEC's Victory in Shadow Trading Case (ruling of September 9, 2024). proskauer.com
Law360, case article listing for the 2024 jury case, latest item June 11, 2026. Read as a listing of headlines. law360.com
Federal Trade Commission, Bureau of Competition staff, Avoiding antitrust pitfalls during pre-merger negotiations and due diligence. March 20, 2018. ftc.gov
Federal Trade Commission, FTC and DOJ Withdraw Guidelines for Collaboration Among Competitors. December 11, 2024. ftc.gov
Federal Trade Commission and Department of Justice Antitrust Division, request for public comment on possible guidance on collaborations among competitors. February 23, 2026. ftc.gov
Applied Clinical Trials, Enrollment Performance: Weighing the Facts (on the 2012 Tufts site study). appliedclinicaltrialsonline.com
US Department of Health and Human Services, ASPE, Examination of Clinical Trial Costs and Barriers for Drug Development. July 24, 2014. aspe.hhs.gov
Society of Chemical Industry, Pharma R&D: What's in the pipeline? Chemistry & Industry, issue 5, 2026 (on Citeline's Pharma R&D Annual Review 2026). soci.org
BIO, Informa Pharma Intelligence and QLS Advisors, Clinical Development Success Rates and Contributing Factors 2011-2020. bio.org
Ken Research, Global Competitive Intelligence Software Market report. kenresearch.com
Trinity Life Sciences, How AI is transforming pharmaceutical competitive intelligence (citing TGaS Advisors surveys and PMPRB, ISPOR 2025). trinitylifesciences.com
Oami T, Okada Y, Maeda K, Nakada T. Performance of large language models and prompt engineering strategies for data extraction in systematic reviews. Front Digit Health 2026;8:1799623. PubMed
US Food and Drug Administration, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products. Draft guidance, January 2025. fda.gov
European Commission, AI Act regulatory framework page (AI Omnibus, in force July 27, 2026). digital-strategy.ec.europa.eu
Draft EU GMP Annex 22, Artificial Intelligence. Consultation text, July 7 to October 7, 2025; not on the EudraLex Volume 4 page on November 3, 2026. picscheme.org
O*NET OnLine, Market Research Analysts and Marketing Specialists, 13-1161.00. 2025 wage and employment data. onetonline.org
Smith ZP, DiMasi JA, Getz KA. New Estimates on the Cost of a Delay Day in Drug Development. Ther Innov Regul Sci 2024;58:855-862. PubMed
Tufts Center for the Study of Drug Development, day of delay white paper, August 2024. csdd.tufts.edu
Next step
See it on your own watch list.
Explore the solution, or bring one indication's rivals and your development dates, and we will run a watch list with you, every claim linked to the public passage behind it.
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