AI Platform for Clinical, Cosmetic and Medical Device Study Protocol Design

Synthetrial’s protocol design platform uses artificial intelligence to generate a complete and structured first draft of a pharmaceutical, cosmetic or medical device study protocol within minutes.

Based on an initial description of the product and study objectives, the platform proposes the main protocol sections, including objectives, study population, eligibility criteria, endpoints, methodological design, procedures, assessment schedule and statistical planning.

The platform also contextualizes the proposed design using information from previous studies in the same therapeutic area, product category or indication. This enables teams to:

• Reduce the time required to prepare initial protocol versions.

• Review designs and criteria used in previous studies.

• Compare endpoints, populations and methodological approaches.

• Define efficacy, safety, tolerability and performance assessments.

• Identify potential inconsistencies or missing elements.

• Evaluate alternative designs before finalizing the protocol.

• Facilitate collaboration between clinical, scientific, statistical and operational teams.

The platform can support the design of pharmaceutical clinical trials, cosmetic efficacy and safety studies, and medical device investigations. It does not replace expert or regulatory review but provides a comprehensive and structured starting point that accelerates iterations and improves consistency.

It is designed for pharmaceutical, biotechnology, cosmetics and medical device companies, as well as CROs, testing laboratories, investigators and study sponsors.