Sponsored Research
AI Contract Review for Research Institutions
Every clinical trial agreement, reviewed to your positions, before you sign
ReviewPro evaluates each incoming sponsor and CRO agreement against your institution’s positions, in minutes, inside Microsoft Word.
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At an academic medical center or a research hospital, no study enrolls a subject until its clinical trial agreement is signed, and the office that reviews those agreements is measured on how quickly that happens.
The agreement arrives from the sponsor or the CRO, drafted to protect the study, the drug, and the data. The terms that protect the institution are the site’s to ask for. Under an activation deadline, they are the ones a reviewer reaches last: publication rights, who pays when a subject is injured, and what the institution has agreed to that its compliance office would not allow.
LegalSifter ReviewPro
Your positions applied to the sponsor’s paper
ReviewPro returns a structured first-pass redline on each incoming agreement, applying your positions on the human-subjects terms, the publication and data terms, and the risk and payment terms that set the site’s exposure.
Your contracts and legal teams review the exceptions rather than the queue.
Clinical trial agreement · Sponsored research review
The Clinical Trial Agreement Checklist
The sponsor or CRO writes the agreement to protect the study, the drug, and the data. These are the terms to require and to reject before your site signs, read from the side that treats the subjects and stands behind the research.
Protecting the subjects and the science
IRB approval
The study proceeds only under your IRB’s prior and ongoing approval.
Watch for: Language that lets the study start, or continue, without your IRB’s review governing.
Informed consent
Consent obtained under IRB approval and applicable law, with the sponsor limited to review and comment.
Watch for: A sponsor given control over the consent form or process, rather than a right to review and comment.
Safety reporting
The sponsor promptly reports safety findings to you, and you may independently communicate them to subjects.
Watch for: One-way reporting, or a bar on telling subjects what you learn about their safety.
Subject injuries
The sponsor bears the cost of trial-related injury to subjects.
Watch for: Known-risk, negligence, or insurance-based exclusions that quietly shift injury costs onto your institution.
No guarantee of results
Nothing obligating you to guarantee outcomes or warrant that the study will achieve any result.
Watch for: A warranty of results, enrollment targets treated as promises, or any guarantee of the science.
Who owns the work, and who can publish
Publication rights
You and the investigator keep the right to publish, with sponsor review limited to a defined window to flag confidential information or request a patent-filing delay.
Watch for: Sponsor consent or approval to publish, indefinite review periods, or a right to suppress results.
Study data ownership and use
Even where the sponsor owns the data, you retain access and use for research, education, publication, and patient care.
Watch for: Sponsor ownership with no reserved license back to you, leaving you unable to use your own site’s data.
Intellectual property
The sponsor owns inventions built on its drug, device, or confidential information; you keep an internal-use license and your pre-existing intellectual property.
Watch for: A sweeping assignment of all inventions, or terms that capture your background intellectual property and know-how.
The risk you carry and the money
Indemnification
The sponsor indemnifies you for claims arising from the study and its use of the data, carved back only for your negligence or willful misconduct, and you owe no indemnity beyond the same.
Watch for: A one-way indemnity running only from you, or a duty to indemnify the sponsor for risks inherent in its own protocol.
Sponsor insurance
The sponsor maintains insurance or financial responsibility sufficient to cover liabilities arising from the study.
Watch for: A sponsor that carries nothing, or shifts the burden of proof of coverage entirely onto you.
Limitation of liability
No cap on the sponsor’s liability for subject injury or its indemnity obligations. A mutual waiver of consequential damages is expected and fine.
Watch for: A cap that reaches the sponsor’s exposure for subject injury or indemnity, especially one that binds only you.
Fair market value
Payments consistent with fair market value and not contingent on enrollment numbers or study outcomes.
Watch for: Per-subject bonuses, outcome-based payments, or terms that read as inducement rather than fair compensation.
Termination payment
On termination, the sponsor reimburses costs incurred and non-cancellable obligations.
Watch for: Termination for convenience with no reimbursement, leaving your site holding committed and unrecoverable costs.
Two playbooks written for the institution
Clinical Trial Agreement — Institution reviews a sponsor’s agreement against the positions above. Clinical Trial Agreement: CRO — Institution adds the terms that matter when a contract research organization issues the paper on the sponsor’s behalf, so obligations belonging to the sponsor hold even though the sponsor did not sign the page.
Both are configurable. Start from the proven positions and tune them to your institution’s own policies and risk posture with Playbook Customization.
ReviewPro is not legal advice. Confirm positions with your counsel and your institution’s research-compliance office.
What changes for your institution
Subject-injury cost kept with the sponsor
ReviewPro flags the known-risk, negligence, and insurance-based exclusions that move the expense of trial-related harm onto the institution, and the caps that reach the sponsor’s exposure for it.
Publication rights and data access preserved
The playbook holds the terms that make the work worth doing: the institution and the investigator keep the right to publish, sponsor review is limited to a defined window, and even sponsor-owned data returns to the site for research, education, publication, and patient care.
One institutional standard across every study
Every agreement is evaluated against the same positions, so a multi-site system or a site network holds one standard rather than whatever each study’s reviewer remembered to check.
Activation that does not mean signing blind
A contracts analyst gets a guarded first pass, with guidance on what to accept, counter, and escalate, before the agreement reaches the general counsel’s office or research compliance.
Agreements you cannot redline
A sponsor’s non-negotiable template, a cooperative-group agreement, and flow-down terms from a CRO often arrive on paper the site cannot change.
ReviewPro still shows which of your positions the agreement departs from, so the institution knows what it is accepting before it activates.
Contract-specific AI, refined over more than a decade
ReviewPro runs inside Microsoft Word, where your reviewers already work, with no separate interface and no upload. Each redline carries the reasoning behind it.
- 95%+ first-pass redline accuracy
- Under 5 min per first-pass review
- Microsoft Word and Google Docs
Clinical Trial Agreement FAQ
Does ReviewPro replace our contracts office or our counsel?
No. It runs the first pass against your positions and flags what needs a decision. Subject injury, indemnity, intellectual property, publication, and payment terms that fall outside your positions route to the people who own them.
Can we tailor the positions to our institution’s policies?
Yes. The clinical trial positions are proven and ready to apply, and building your institution’s own positions into the playbook is a setup step we do with you.
Does ReviewPro make a compliance determination on fair market value?
No. It flags payment terms that are not consistent with fair market value or that read as contingent on enrollment or outcomes. Whether an arrangement meets the institution’s compliance obligations is a judgment for your research-compliance office and your counsel.
What happens when the sponsor will not move the terms?
The review still matters. ReviewPro shows which positions the agreement departs from, so the institution decides with the exposure in front of it rather than discovering it later.
How does this fit the systems we already run?
ReviewPro reviews the agreement before it is signed, inside the document. It does not replace the systems that run the study once the agreement is executed.
See ReviewPro on your next clinical trial agreement
Bring a sponsor or CRO agreement your office reviews often and we will run it against the matching playbook.
ReviewPro is not legal advice. Confirm positions with your counsel and your institution’s research-compliance office.