Clinical trial agreement negotiation that answers every site redline from your playbook
Every site redline answered from the playbook, signed in 45 days
See one case, screen by screen ↓Software that takes a site's redline of the clinical trial agreement from the inbox to a response: every change read against the CTA template and the sponsor's negotiation playbook, checked against precedent, the consent form and the fair-market-value benchmark, and answered. Clinical Trial Agreement Negotiation adds six agents that place each change on the fallback ladder, accept what sits inside the contracts manager's authority with the playbook line cited, draft counters and route only out-of-policy clauses to legal.
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Every redline round lands on a clinical contracts manager as a Word file full of tracked changes and margin comments. Each change has to be read against the CTA template and the negotiation playbook — preferred position, fallback 1, fallback 2, walk-away — then checked against what the same institution signed last time, the approved consent form for subject-injury wording, and the fair-market-value benchmark for anything touching payment. That is hours of reading per round, before a single reply is drafted.
Meanwhile the changes the playbook already allows — a 5-year confidentiality term, the institution's own state law, a reference to its HIPAA authorization — wait in the same legal queue as the indemnity edits that genuinely need a lawyer. Each round adds a week or two, concessions drift from one site to the next with no record of why, and an unsigned agreement is a selected site that cannot enrol.
Estimated split of the contracts manager's working hours for one 20-change redline round, by hand and with the solution.
Six specialist agents place every change on the playbook ladder; the contracts manager confirms counters and legal decides only the out-of-policy clauses.
Marlowe University Hospital in Columbus, Ohio — PI Dr. Elena Varga — is a site for VLT-302, Northwind Bio's Phase 3 psoriasis study. On day 19 of a 45-day target, its round 2 redline arrives. Here is what happens next, screen by screen, in the working solution.
Rachel Kim, Marlowe's negotiator, sends Marlowe_VLT-302_CTA_round2_redline.docx: 22 pages, 19 tracked changes and 12 comments. Priya sees every change as the site made it — section, page, the struck and inserted text and Rachel's margin comment — beside an empty playbook ladder. Her authority is set to accept automatically up to Fallback 2.
“Inside this line a change is accepted with its playbook citation. Counters wait for you; no approved position goes to legal.”
The redline reader maps the 19 changes and 12 comments to template v2026.1. The playbook checker places all 19 on the ladder: 13 on an approved fallback, 4 past it but answerable with one, 2 with no approved position. The precedent finder pulls the CRV-118 agreement Marlowe signed on Mar 14, 2024 — 5 matching clauses. The protocol and consent checker matches §10.2 and §10.3 to Marlowe's consent form v3.0 and protocol §10.4, and the budget checker finds no Exhibit B fee changed.
Each agent's step is shown as it runs, with what it found and how long it took.
A 19-cell strip colours the whole redline by outcome. Seventeen of the 19 changes resolve at an approved position — accepted up to Fallback 2, counters at Fallback 1 or 2. Each accepted row quotes the playbook line and its rule: payment within 30 days and a 5% holdback is Fallback 1 of PAY-04; the 5-year confidentiality term is Fallback 1 of CON-02 and was also signed with Marlowe in 2024.
“13 accepted with citations · 4 for you · 2 to legal”
Dropping the insurance-first condition is Fallback 1 of INJ-01 — “Sponsor pays without first billing the subject's insurance…” — and Marlowe signed the same in 2024. Covering injury from the two study-only punch biopsies is Fallback 2. Marlowe keeping inventions made independently of the study drug and protocol is Fallback 1 of IP-01. Every automatic acceptance has an Undo.
Rachel Kim: “Our IRB will not approve consent language that leaves participants billing their own insurer first.”
§9.1 deletes the protocol-deviation carve-out, and no approved position deletes it. The recommendation for Omar Haddad: counter with Fallback 1 — keep the carve-out, but not for deviations made to protect a Study Subject's safety, the exact wording Marlowe signed for CRV-118. §9.2 adds “solely” and “gross”, which would make the sponsor pay for Marlowe's own ordinary negligence.
“IND-02 · Walk-away: Sponsor never indemnifies Institution for its own negligence or misconduct, and never accepts uncapped consequential damages.”
Publication: Marlowe cut review from 60 to 30 days and removed the patent delay; the counter is 45 days plus the 60-day patent delay — Fallback 1, and what Marlowe signed in 2024. Monitoring goes back to 10 business days' notice with remote source review kept; insurance accepts $10M per occurrence but offers a certificate of insurance instead of naming Marlowe as an additional insured; the $7,500 wind-down fee applies only if the study ends within 6 months of the first subject's enrolment. Priya confirms each one.
The board lists every clause with its state, the six that need judgement first, and the precedent used: 5 of the 19 changes match what Marlowe already signed — confidentiality, indemnity, subject injury, publication and governing law. The activity panel shows each agent step and each round since the template went out on Aug 30.
“19 changes from Marlowe — 13 accepted inside your authority, 4 for you, 2 with legal”
Omar's exceptions queue holds only what falls outside the playbook, from every site. For Marlowe §9.2 he sees the site's text, the IND-02 walk-away line and the recommendation — hold the negligence exclusion and offer mutual indemnity, each party for its own negligence (Fallback 2). He can approve the recommendation, hold our position or approve the site's text, and leave a note for the contracts manager.
“Decided as Omar Haddad · recorded with name, date and time”
The response redline shows the changes accepted clean and the sponsor's changes tracked, with a margin note on each. The cover email to Rachel Kim, copied to Dr. Elena Varga and Sam Patel, says 13 changes are accepted as written, 4 clauses carry wording that matches CRV-118, and 2 items are under internal review with a reply by Oct 10. The .docx response and the Exhibit B budget are attached.
“Nothing reaches the site until you send it. Every comment cites the playbook or an agreement Marlowe already signed.”
The signature runway shows each agreement's days since the template went out, coloured by who held the pen — sponsor, site, legal or budget, signature — against the dashed 45-day target. Marlowe is on day 19, our move; Copperline Cancer Institute, round 4 of CRV-118, is the one past the target on day 52.
The same redline, seen by the four people who carry it — what their week looked like, and what it looks like now.
Six specialist agents place every change on the playbook ladder; the contracts manager confirms counters and legal decides only the out-of-policy clauses.
Reads the site's Word redline exactly as sent — tracked changes and margin comments — and maps every change to a template clause, keeping the site's comment with it.
Places every change on the position ladder — preferred, fallback 1, fallback 2, walk-away — and applies the country rules for the UK model agreement, the French convention unique, Germany, Japan and the US.
Finds what the sponsor signed with the same institution or network before, clause by clause, and highlights the signed text.
Checks subject-injury, record, sample and data clauses against the protocol and the site's approved consent form.
Compares fees and payment terms with the fair-market-value benchmark and routes anything outside the range to the budget owner.
Drafts the reply for each clause, routes exceptions to their owners, then builds the response redline and cover email from the decisions.
Confirms counters; legal decides the rest. The agents propose; a named person decides.
Ask about any site agreement, clause or precedent in plain words. Every answer points to the playbook line or the signed agreement it came from.
Which agreements are waiting on us?
Four agreements are your move today: Marlowe (round 2 redline, 19 changes, day 19), Saint-Clair (legal decided — apply it, day 29), Fernhill (1 clause to decide, day 22) and San Aurelio (3 clauses to decide, day 8). Saint-Clair is closest to the 45-day target — one click applies Omar's decision.
What did we agree with Marlowe on publication in 2024?
In the CRV-118 agreement signed on Mar 14, 2024, Marlowe accepted a 45-day review before submission and kept our 60-day patent delay. Their round 2 redline asks for 30 days and no patent delay — the drafted reply goes back to the 2024 terms, which is also Fallback 1 in the playbook.
Why did the two indemnity edits go to legal?
Both §9 edits fall outside every approved position. §9.1 deletes the protocol-deviation carve-out — every rung of IND-02 keeps it. §9.2 adds “solely” and “gross”, which would make us pay for Marlowe's own ordinary negligence — that is the walk-away. Omar Haddad has both, each with a recommendation; for §9.1 it is the wording Marlowe signed in 2024.
Which sites will miss the 45-day target?
Two open agreements are past or close to it: Copperline on day 52, with the site reviewing our IP counter, and Rheinfeld on day 34, with its liability cap at legal. Approving the Rheinfeld recommendation today keeps it inside the target; Copperline needs a call with the site's technology transfer office.
13 screens from the working solution, on its sample data. Pick one to see it large.
What the agents may settle, who decides the rest and how the clocks run are settings, set by your contracting team.
| Setting | Default | Choose from |
|---|---|---|
| Accept automatically when the site's text sits on | Up to Fallback 2 | Up to Fallback 2 · Up to Fallback 1 · Nothing automatic |
| Past the walk-away, or no approved position | Always the legal owner | Always legal, with the playbook line quoted and a recommendation |
| Decision owners | Legal: Omar Haddad · Budget: Lena Ortiz · Medical: Dr. Maya Chen | A named person for legal, budget, medical and the playbook |
| Target, template to signature | 45 days | Step up or down; agreements past it turn red on the runway |
| Remind the site after | 10 days | Days the site holds the pen before a reminder email is drafted |
| Accept changes we already signed with this site | On | Matches an agreement signed with the same institution in the last 24 months · Off |
| Send a clause rejected twice to legal | On | On · Off |
| Signing order | Institution, then Northwind Bio | Institution, then Northwind Bio · Northwind Bio, then institution |
Every figure is labelled: 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 redline · “target” = the design goal, measured in the live solution · “estimated” = our estimate · “typical” = published figures (CTSA prospective study of 29 US academic institutions — median 39 days to final negotiation, 91 to execution; NCURA 2025 — 90+ days industry average). People, sponsors, sites, studies and documents named on this page are fictional — characters and sample data in the working solution.
Software that takes a site's redline of the clinical trial agreement from the inbox to a response: every change read against the CTA template and the sponsor's negotiation playbook, checked against precedent, the consent form and the fair-market-value benchmark, and answered. Clinical Trial Agreement Negotiation adds six agents that place each change on the fallback ladder, accept what sits inside the contracts manager's authority with the playbook line cited, draft counters and route only out-of-policy clauses to legal.
Each change is placed on the playbook ladder for its clause family — preferred, fallback 1, fallback 2, walk-away. A change that sits on an approved fallback inside the authority you set (nothing, Fallback 1 or Fallback 2) is accepted with its rule quoted, and can be undone. Nothing goes back to the site until a contracts manager sends the response.
Only changes past the walk-away or with no approved position, such as an indemnity edit that deletes the protocol-deviation carve-out. The legal owner gets the clause, the site's ask, the walk-away quoted and a recommendation with precedent. A clause the site rejects in two rounds can also be sent to legal, by setting.
Yes. The precedent finder looks up executed agreements with the same institution or network, clause by clause, and shows the signed text and signature date. Only fully signed agreements count, and counters can go back to the terms the site already accepted.
Yes. The protocol and consent checker compares subject-injury, record, sample and data clauses with the protocol and the site's IRB-approved consent form, flags any promise the form does not make, and sends wording conflicts to the medical owner. Fees and payment terms are checked against the fair-market-value benchmark.
The playbook carries country rules the agents apply before any clause is classified: for the UK model agreement they check that only the appendices changed and route any edit to legal; for France only the annexes of the convention unique are negotiated; German liability caps and Japanese controlling-language requests go to legal.
Yes. The agents accept only inside the authority you set and never send anything to a site. The contracts manager confirms every counter and sends every response, decision owners decide everything outside the playbook, and only the playbook owner can approve a new fallback.
The Agentic Solution Engine builds and deploys it from your requirements and documents — your CTA templates, negotiation playbook and a sample of past redlines and executed agreements — and it goes live once every quality gate has passed. We will walk you through it on your own redlines first.
A checked first-draft protocol in days, in your approved language.
1-min demoeTMF Quality CheckAn inspection-ready trial master file every day, each site scored on what is due today.
1-min demoClinical Study Report AuthoringResults drafted within days of database lock, linked to tables.
1-min demoWe'll run Clinical Trial Agreement Negotiation on your own playbook and a sample of your past site redlines.