Terms of Use
Last updated: 20 May 2026 (version 2.0).
1. Purpose
These Terms of Use (the "Terms") govern access to and use of the Protocolis platform (hereinafter "the Service") published by the entity described in the legal notice (hereinafter "the Publisher").
Any use of the Service implies full and unreserved acceptance of these Terms and of the privacy policy.
2. Description of the Service
Protocolis is a software platform that assists with the drafting and qualification of academic clinical research documents, aimed at professionals (investigators, research offices, methodologists, sponsors). The Service includes the following modules:
- AI Synopsis — conversational assistance for drafting clinical study synopses
- Protocol generation — production of a complete protocol from a validated synopsis, using templates by regulatory category (RIPH 1, 2, 3) and by institution
- Regulatory chat — Q&A assistant sourced from official public regulatory references (CNIL, Jardé Act, ICH E6, French Public Health Code, EU Regulation 536/2014)
- Regulatory qualification — automated analysis of an imported synopsis or protocol (PDF / Word) to determine its RIPH category and the checklist of associated formalities (ethics committee, ANSM, CNIL, ClinicalTrials.gov)
3. Beta phase
The Service is currently offered as a free beta. Features may evolve, be modified or suspended without notice. The transition to a paid commercial offering is planned for July 2026; the User will be informed at least 30 days in advance before any billing.
During the beta phase, the Service is provided "as is" with no guarantee of continuity or performance. The Publisher endeavours to ensure availability of the Service but undertakes no obligation of result.
4. Service access and account creation
Access to the Service requires the creation of a personal account using an email address and a password. The User undertakes to provide accurate information and to keep their data up to date in case of changes.
The User is solely responsible for the confidentiality of their credentials. Any action carried out from their account is deemed to originate from them. In case of suspected compromise, the User must immediately inform the Publisher at contact@protocolis.fr.
The Service is reserved for clinical research and healthcare professionals. The User undertakes not to create an account on behalf of a third party or to transfer their credentials.
5. Prices and billing (from July 2026)
From the end of the beta phase, the Service is offered according to a price list detailed on the pricing page. Payments are handled by our provider Stripe Payments Europe, Ltd.. Card details are never stored by the Publisher.
The specific conditions applicable to paid plans (commitment period, termination conditions, SLA) are specified at the time of subscription.
6. User responsibilities
The User undertakes to:
- Use the Service in accordance with its professional purpose and these Terms
- Not enter or upload any personal data relating to a patient (name, surname, national ID, identifying health data). The Service is exclusively intended for the design of clinical studies, upstream of any patient data collection.
- Verify the accuracy of AI-generated content before any use, submission or publication
- Respect the intellectual property rights of third parties (citations, bibliographic references)
- Not attempt to circumvent security measures, not carry out reverse engineering, not overload the APIs beyond reasonable use
7. Limitation of the Publisher's liability
Protocolis is a tool that ASSISTS with drafting and qualification. The outputs of the Service in no way replace the professional judgement and responsibility of the User.
In particular, the Service cannot replace:
- The clinical judgement of the investigating physician
- The expertise of the methodologist or biostatistician
- The final regulatory qualification, which is the responsibility of the sponsor, the research office, the Ethics Committee (CPP) and, where applicable, the ANSM
- Peer review and validation by research bodies
RIPH classifications (1, 2, 3, RNIPH), formality checklists, and the drafting of methodology or statistical analysis plans are AI-assisted proposals. The User retains full responsibility for validating and using them. The Publisher cannot be held liable for any classification error, omission or inaccuracy in the outputs of the Service, nor for any consequences (ethics committee refusal, ANSM review delay, etc.) that may result.
The Publisher's liability shall in no event exceed, towards any User, the amount actually paid by that User over the last 12 months (zero during the beta phase).
8. Personal data
The processing of personal data by the Publisher is described in detail in the privacy policy. That policy lists the processors (Anthropic for AI, OpenAI for embeddings, Resend for emails, Umami for statistics, Airtable for the CRM, Stripe for upcoming payments), the non-EU transfers governed by the Standard Contractual Clauses, and the retention periods.
By using the Service, the User acknowledges having read the privacy policy.
9. Use of artificial intelligence
The Service integrates the Claude language model (published by Anthropic, PBC) for guided drafting and classification. Conversations, synopses, protocols and uploaded documents are sent to the Anthropic API for the sole purpose of generating the requested output.
Anthropic contractually undertakes, under its enterprise API offering, not to reuse customer data to train its models. This data is retained by Anthropic only temporarily, to the extent necessary for abuse detection, in accordance with its commercial terms.
10. Sharing between Users
A User may, on their own initiative, share a study with one or more collaborators (for example their research office). Sharing is explicit, initiated by the User through an email invitation. Sharing may be revoked at any time.
When a collaborator accepts an invitation, they gain read/write access to the shared study. Every shared user remains subject to these Terms and to the privacy policy.
11. Intellectual property
11.1. Content produced by the User
The synopses, protocols and documents produced via the Service belong to their author (the User). The User grants the Publisher, free of charge, a limited, non-exclusive and non-transferable licence to store, technically reproduce and process them, for the sole purpose of providing the Service. This licence ends when the account or the study is deleted.
11.2. Platform and trademarks
All elements composing the Service (software, architectures, trademarks, illustrations, editorial content) remain the exclusive property of the Publisher. Any unauthorised reproduction is forbidden.
12. Suspension and termination
The User may delete their account at any time from the settings page of their personal area. Deletion is final and immediate: all data (studies, conversations, protocols) is erased, in accordance with article 17 of the GDPR. A copy of your data may be obtained beforehand by writing to contact@protocolis.fr (portability, article 20 of the GDPR).
The Publisher reserves the right to suspend or terminate an account in case of serious breach of these Terms, after prior notification where circumstances permit. In case of manifest abuse (security breach, circumvention, unlawful content), suspension may be immediate.
13. Availability, maintenance and force majeure
The Service is provided on a best-effort basis. Interruptions may occur for maintenance; the Publisher endeavours to schedule them outside working hours and to notify Users.
The Publisher cannot be held liable for any failure due to a force majeure event within the meaning of article 1218 of the French Civil Code, or to a failure of a processor beyond its control.
14. Changes to the Terms
The Publisher reserves the right to modify these Terms. Any substantial change is notified to the User at least 15 days before it takes effect, by email or by notification within the Service. Continued use after that date constitutes acceptance of the new version.
15. Applicable law and jurisdiction
These Terms are governed by French law. Failing an amicable agreement, any dispute concerning their interpretation or performance shall be brought before the competent courts of the Lille district (France), subject to mandatory provisions applicable to consumers.
16. Contact
For any question: contact@protocolis.fr