Investigator-initiated study management that shows each funded study's drift before a milestone is missed
See one case, screen by screen ↓Built forESR managersGlobal ESR leadsMedical directorsFinance payment approversClinical supply coordinators
ESR managers retype each progress report, shipment and invoice by hand, so a slipping study is found only once a milestone is missed.
Retyped by hand each quarter
Built-in controls
Each funded study shows its drift at the first late report, while there is still time to recover it.
Investigator-initiated study management is the work a sponsor's medical affairs team does after an investigator's study is approved and its contract signed: tracking milestones against the baseline, reading quarterly progress reports, supplying product, paying invoices against the payment schedule, classifying each transfer of value and closing the study. Many teams call it externally sponsored research (ESR) or investigator-sponsored research. Investigator-Initiated Study Management starts at contract signature, when a study approved in Investigator-Initiated Study Review arrives with its baseline, and runs it to its final report: seven agents read each report, shipping reply, invoice and amendment, and a named person confirms and signs.
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Investigator-initiated study management begins the day the research agreement is signed, and it runs for years: a quarterly progress report from each investigator, invoices against the payment schedule, product shipments, amendments, deliverables and publications, and each payment and shipment classified for transparency reporting. Today that runs on spreadsheets, a grants database and email. The ESR manager retypes screened, enrolled, treated and completed from each report, copies ship dates, lots and expiry dates from fulfillment emails, and checks each invoice line by line against a contract PDF.
So drift is found when a milestone is already missed, and by then the final study report, the manuscripts and the registry results are late too. Milestone invoices arrive before the milestone, duplicates get paid, product requests go by email to three different teams, a lot that expires before the study's last visit is found at the site, and transfers of value are classified at year end from finance extracts. Each therapy area needs its own mandatory fields and steps, so teams work around one form in spreadsheets.
Our estimate for one study in one quarter, by hand and with the agents, where the ESR manager confirms and approves instead of typing. Not measured in the working solution.
One investigator-initiated study tests weekly home self-injection of a study drug in 24 adults with IgA nephropathy over 52 weeks, at one medical center. It was approved in study review, and from contract signature it runs here, against its baseline. Its third-quarter progress report has just arrived. Here is what happens next, screen by screen, in the working solution.
A worked example on sample data. Names, IDs and figures on the screens and in this section come from the demo.
The ESR manager opens the portfolio: 38 active investigator-initiated studies, one thin row each. Hollow marks are the baselined milestones, solid marks the actual or forecast ones, and the gap between them is the drift in weeks. Two studies sit in At risk and ten in Drifting, each band with one line from the agents on why. Needs you lists 4 reports to confirm, 3 shipments, 6 invoices, one amendment, one close-out, and a new study just arrived from review at contract signature with its baseline.
“Third quarter: 34 of your 38 reports are in and read. The study’s report has just arrived: 9 enrolled against 16 planned.”
The study's 3-page progress report arrives through the investigator portal, uploaded by the study coordinator. The quarterly report reader reads the enrollment table (screened 14, enrolled 9, treated 9, completed 2), each figure cited to page 2, open on the left. Against the plan of 16 enrolled by quarter end, the study is 7 behind. At 1.17 patients a month over two quarters, last patient in is forecast 30 weeks late, with a range around it, and the study moves from Drifting to At risk: seven steps in 6.4 seconds.
“Drifting → At risk · rule: more than 12 weeks late on last patient in.”
The relabeling vendor confirms dispatch of 40 vials of the study drug, sent through the vendor because the site's pharmacy cannot apply study labels. The supply tracer reads the dispatch email and packing list and fills ship date, quantity, lot, expiry, courier tracking, temperature logger and labels, each cited, nothing typed. It records the transfer of value, 40 vials × $4,850 = $194,000 of in-kind research support, and flags the lot.
“The lot expires 7 weeks before the study’s forecast last patient last visit.”
The ESR manager clicks Ask for a later lot. The supply tracer drafts and sends the request to the vendor, reads the reply and refills the record with a new lot whose expiry falls after the study's forecast last visit. The flag clears, and the ESR manager confirms the shipment record. Nothing was typed by hand.
“The new lot outlasts the study. Flag cleared.”
The ESR manager confirms the quarter's figures and approves the drafted recovery plan with one electronic signature. Five actions, each with an owner and a date: a second site with its own investigator; referral letters to 6 community nephrology clinics; protocol amendment 2 to widen kidney function to eGFR ≥ 30, sent to the IRB; a monthly call; and milestone 3, $96,000, held until the second site is open. The drafted message to the investigator waits for the ESR manager to edit and send through the portal.
“Figures confirmed and recovery plan approved by the ESR manager · meaning: Approved · milestone 3 held.”
The site's invoice asks $26,800, the per-patient fee for the 4 patients enrolled in the quarter. The invoice matcher ties it to the contract's $6,700 per enrolled patient and to the report the ESR manager confirmed, checks the $33,500 already paid against the $160,800 cap, and classifies it as a research payment for Open Payments, in the current program year, with the site's investigator named as principal investigator. The ESR manager reviews it; the finance payments approver approves it as the second person, and it goes to accounts payable by API in the afternoon run.
The invoice matcher's guardrail: “Never approves a payment.” Unearned milestones are held, and a person rejects a duplicate.
Another study's protocol amendment 3 extends follow-up from 12 to 24 months. The amendment reader compares it with the baseline and proposes the re-baseline: last patient last visit and the final study report each move a year later, and a secondary manuscript is added. The budget rises $84,000 to $674,000. That is 14.2%, above the 10% rule, so a contract amendment is raised, and product rises by 288 bottles, flagged to the clinical supply coordinator.
The amendment reader drafts a re-baseline and does not apply it: the ESR manager proposes it, and the global ESR lead approves.
A pediatric study enrolled 3 of 20 children in 22 months and missed two recovery plans, and its investigator agrees to close early. The close-out assembler builds the case: enrollment against plan, the two recovery attempts, the spend ($186,400 paid of $512,000, a final payment of $18,200, $307,400 released) and the product: 60 bottles shipped, 22 dispensed, 12 needed to finish, 26 to destroy at the site with a certificate. The ESR manager prepared it and cannot sign; the medical director has signed, and the global ESR lead signs next.
“Recommended: early close. No new patients; the 3 enrolled children finish their 52 weeks.”
The deliverables tracker lists 17 deliverables due in the next 120 days (interim reports, abstracts, posters, manuscripts, final study reports and registry results) and 2 overdue. It reads one completed study's 84-page final study report against the protocol's report content and finds 11 of 12 sections: the month-24 eGFR slope table is missing. That study's ClinicalTrials.gov results fall due under 42 CFR 11.44, and as an ESR collaboration its co-authorship obligations are tracked too.
The tracker does not accept a deliverable itself: the choice is “Ask for the missing table” or “Accept with a note”.
Each step by people and agents is on the audit trail: who, what, when, on which study, the meaning of each signature and the evidence behind it. The QA auditor exports an inspection pack for the study from its start to today: the audit trail in CSV and PDF, the electronic signature manifest with meanings, the source documents the agents cited, agent and model versions per run, the configuration versions in force, and roles and access during the period.
“For FDA and EMA inspections, internal audit and partner audits. The pack is hashed (SHA-256).”
One funded study from contract to final report, for five roles, then and now.
Reports, shipping replies, invoices and amendments are read as they arrive, and each study is forecast and its recovery drafted; the ESR manager confirms, and finance, supply and the study's leads sign as second persons.
Reads each investigator's quarterly progress report from the portal, extracts screened, enrolled, treated, completed and discontinued with the page cited, compares them with the baselined plan, forecasts last patient in with an 80% range, sets the band and drafts the recovery conversation and plan.
Checks each product request against the approved total and what has shipped, routes it to R&D clinical supply, the commercial order desk or the relabeling vendor by supply type, fills ship date, quantity, lot, expiry, tracking and logger from the fulfillment reply, flags a lot that expires before the forecast last visit, and chases the receipt.
Ties each invoice line to the research agreement's payment schedule and to the evidence that earns it, checks what is already paid, the cap and duplicates, and classifies the transfer of value for Open Payments and EFPIA.
Compares a protocol or contract amendment with the study's baseline and proposes the re-baseline of milestones, budget, product and deliverables, flagging when a contract amendment is needed.
When a study cannot recover, builds the early close or termination case: enrollment history, recovery attempts, spend to date, product to reconcile or destroy, final payment, registry update and notices.
Tracks interim reports, abstracts, posters, final study reports, manuscripts and registry results against their due dates, reads each final study report for completeness against the protocol, and tracks collaboration obligations.
At go-live, maps a legacy portfolio file's columns to fields, validates each row against its business unit's mandatory fields and checks for duplicates, and prepares a dry run for a person.
Confirms; second persons sign.
Ask which studies will miss their final report, how much product is left to ship, which invoices are waiting on evidence or which reports are missing. Each answer names the studies and points to the source behind it. These answers use the sample data.
Which studies will miss their final study report date?
Three of your studies. The IgA nephropathy study is forecast 30 weeks past its final study report date. The pediatric study has 3 of 20 enrolled, and an early close is proposed. A third study has two quarterly reports missing, last forecast +16 weeks. Across the whole portfolio, 34 studies are At risk, 21 of them for enrollment.
How much product is left to ship for this study?
The study has 1,560 vials approved, 320 received in 8 shipments, 40 packed to ship tomorrow, and 1,200 left. The packed shipment now carries the later lot, which outlasts the study's forecast last visit.
Which invoices are waiting on evidence?
Two of your six. One study's milestone 4 invoice, $54,000: its third-quarter report shows 22 of 24 enrolled, so last patient in is not yet earned. A completed study's milestone 6 invoice, $72,000: its final study report has 11 of 12 sections. The site invoice for the IgA nephropathy study is now earned, since its report is confirmed.
Which third-quarter reports are still missing?
Four of your 38, due in two days. One of them also missed the second quarter and was escalated to the medical director. Reminders went out through the portal five days ago; the next goes on the due date.
From the working solution, on its sample data. Pick one to see it large.
The rules the agents apply, and the fields and steps each business unit requires, are settings. Each change is versioned in the audit trail, and a new field configuration is approved by a second administrator.
| Setting | Default | Choose from |
|---|---|---|
| Drift bands | On track within 4 weeks · Drifting 5–12 · At risk over 12 weeks, or a forecast past a deliverable date | 4 / 12 weeks · 6 / 16 weeks |
| Quarterly report due | 30 days after quarter end | 15 days · 30 days · 45 days |
| Report reminders | Day 0 and 7, escalate to the medical director on day 14 | Day 0 and 7, escalate day 14 · Day 0, escalate day 7 |
| Bulk confirm threshold | 0.95 — reports matching plan within 10% may be confirmed together | 0.90 · 0.95 · 0.98 |
| Lot expiry | On — a shipped lot must outlast the study's forecast last patient last visit | On · Off |
| Receipt chase | 5 days | 3 days · 5 days · 7 days |
| Contract amendment | When an amendment moves the budget by more than 10% | 5% · 10% · 15% |
| Product value for transparency | Wholesale acquisition cost | Wholesale acquisition cost · Standard cost |
Each figure carries its label: a target the solution is built to, an estimate, a typical published result, or a proven one.
“demo” = seen in the working solution, on its sample studies · “target” = the design goal, measured in the live solution · “estimated” = our estimate, not measured · “typical” and “published” = published figures (Carlisle et al., 2,579 phase 2–3 trials closed in 2011). Context on research payments and results: 42 CFR 403.904 (CMS Open Payments), EFPIA Disclosure Code, 42 CFR 11.44, Regulation (EU) 536/2014 Art. 37, ICH E6(R3). Names on the screens are sample data.
Investigator-initiated study management is the work a sponsor's medical affairs team does after an investigator's study is approved and its contract signed: tracking milestones against the baseline, reading quarterly progress reports, supplying product, paying invoices against the payment schedule, classifying each transfer of value and closing the study. Many teams call it externally sponsored research (ESR) or investigator-sponsored research. Investigator-Initiated Study Management starts at contract signature, when a study approved in Investigator-Initiated Study Review arrives with its baseline, and runs it to its final report: seven agents read each report, shipping reply, invoice and amendment, and a named person confirms and signs.
Each active study is one row on the portfolio river. Hollow marks are the baselined milestones (contract signed, first patient in, interim, last patient in, last patient last visit, final study report, manuscript) and solid marks the actual or forecast ones; the gap is the drift in weeks. Studies sit in three bands, On track within 4 weeks, Drifting 5–12 and At risk over 12 weeks or with a forecast past a deliverable date, each with a cited reason.
Yes. When a quarterly progress report arrives through the investigator portal, the quarterly report reader extracts screened, enrolled, treated, completed and discontinued and the screen-failure reasons, each cited to its page. It compares enrollment with the baselined plan, forecasts last patient in with an 80% range and drafts a recovery plan for a study At risk. The ESR manager confirms the figures; missing reports get reminders on day 0 and day 7 and escalate to the medical director on day 14.
The supply tracer checks each product request against the approved total and what has shipped, and routes it to R&D clinical supply, the commercial order desk or the relabeling vendor by supply type. It reads the dispatch email and packing list, fills ship date, quantity, lot, expiry, tracking and temperature logger, each cited, and flags a lot that expires before the study's forecast last patient last visit. The supply coordinator approves each shipment as the second person, and the investigator acknowledges receipt in the portal.
The invoice matcher ties each invoice line to the research agreement's payment schedule and to the evidence that earns it (a confirmed quarterly report, an accepted deliverable, a signed amendment) and checks what is already paid, the cap and duplicates. It classifies each payment and product shipment as a transfer of value: Open Payments category, form, recipient, principal investigator and program year, or EFPIA R&D for EU sites. The ESR manager reviews, finance approves as the second person, and approved payments go to accounts payable by API or SFTP CSV.
The amendment reader compares a protocol or contract amendment with the baseline and proposes new milestones, budget, product and deliverable dates, each cited to the amendment; a budget move above 10% raises a contract amendment. The ESR manager proposes and the global ESR lead approves. When a study cannot recover, the close-out assembler builds the early close or termination case, and it closes with two signatures, the medical director's and the global ESR lead's; the person who prepared it cannot sign.
No. The agents read, match, forecast and draft, and make no decisions. They do not change a baseline, approve or release a payment, ship product, send a message to an investigator or close a study. A reading below a confidence of 0.95 goes to a person, each decision is an electronic signature with its meaning, and the person who prepares an item does not approve it.
Your existing portfolio comes in from a flat file: the portfolio import mapper maps the columns, checks each row against its business unit's mandatory fields and for duplicates, and a person approves the import after a dry run. The Agentic Solution Engine builds and deploys the solution from your requirements and documents (your research agreements and payment schedules, each business unit's fields and steps, and a sample of past quarterly reports, shipping replies and invoices), and it goes live once each quality check has passed. We will walk you through it on your own studies first.
Every field insight becomes a cited theme within days, with an owner for the next step.
1-min demoMedical Inquiry Intake & TriageEvery question routed, and hidden complaints reach quality in one business day.
1-min demoMLR Review AutomationEvery claim checked against its reference before committee.
1-min demoWe'll run Investigator-Initiated Study Management on a sample of your own quarterly reports, shipping replies and invoices.