From synopsis to full protocol, without rewriting everything
The protocol extends the synopsis: same objectives, same endpoints, sections expanded with the rigor expected by the research office and the ethics committee.
How it works
Guided expansion, not a copy/paste
- 1
Validated synopsis as input
The protocol generation starts from a synopsis marked as complete: it sets the objectives, the design and the population.
- 2
Expansion driven by classification
The AI selects the right template — RIPH 1, 2, 3 or non-interventional — and fills in the regulatory, statistical and operational sections.
- 3
Word export with research office template
Ready-to-share .docx: universal ICH-GCP sections, plus the institution-specific blocks when your research office template is provided.
What you get
The protocol as a natural extension of the synopsis
Synopsis ↔ protocol consistency
Editing an objective in the synopsis updates the protocol accordingly — no more silent drift between the two documents.
Template adapted to classification
RIPH 1 (drug), RIPH 2 (device), RIPH 3 (non-product), non-interventional: each classification triggers the right protocol skeleton.
Regulatory sections served
Pharmacovigilance, adverse events, monitoring committee, ethics committee and regulator submissions: the technical blocks come pre-filled and sourced.
Editable Word export
Structured .docx, bilingual EN/FR, that fits inside the research office templates provided by your institution (Team and DRCI plans).
Frequently asked questions
What you should know before generating a protocol
Do I need a completed synopsis to generate the protocol?
Yes. The synopsis is the structural backbone of the protocol: as long as it is in draft, the generate button stays locked. You can return to the synopsis at any time, the protocol updates accordingly.
Does the protocol respect my hospital's internal templates?
Universal ICH-GCP sections are always present. To integrate an institution-specific template (Bordeaux, AP-HP, GHICL...), your research office shares its skeleton with us via the Team or DRCI licence and we instantiate it on the platform.
How is the regulatory classification determined?
The AI proposes a classification (RIPH 1/2/3 or non-interventional) from the synopsis and justifies it against the French Loi Jardé. The final decision belongs to the sponsor and the ethics committee — the tool exposes the reasoning to make that conversation easier.
Does the protocol cover retrospective studies on data?
Yes. The non-interventional template (RNIPH) is supported, with the expected CNIL/MR-004 elements. The module is currently being refined with a research office project lead specialised in retrospective studies.
From synopsis to protocol, without rewriting everything
Trigger protocol generation from a completed synopsis. You stay in control of every section, the AI drafts the rigor expected by reviewers.