Kayentis has launched an AI-powered eConsent module designed to improve patient understanding of clinical trials and simplify consent management for sponsors and sites.

Kayentis has launched an electronic informed consent (eConsent) module integrated into its electronic Clinical Outcome Assessment (eCOA) platform, expanding its clinical trial technology offering beyond patient data collection.

The new module is designed to address longstanding concerns about participant understanding during the informed consent process. Research has shown that many clinical trial participants struggle to fully understand information presented in consent forms, particularly around study risks, randomisation and the investigational nature of treatments.

The company said its AI-powered system converts traditional consent documents into an interactive digital format incorporating multimedia content, accessibility features and comprehension checks.

According to Kayentis, participants can access videos explaining study procedures, use an interactive glossary to explore unfamiliar terms and complete questions designed to assess understanding before consent is given.

The company also said the technology aims to reduce administrative complexity associated with consent management in multinational clinical trials. Sponsors frequently need to manage multiple document versions, translations, ethics committee updates and re-consent requirements across different countries.

Guillaume Juge, chief executive officer at Kayentis, said: “We believe better participant engagement shouldn’t come at the cost of added complexity for sponsors and sites. Our eConsent module integrates seamlessly into existing workflows, providing an intuitive participant experience without requiring process changes or additional systems.”

The module is available through the existing Kayentis eCOA platform and supports on-site, remote and hybrid consent models. The company said it is compliant with 21 CFR Part 11 requirements for electronic records and signatures and can integrate with Interactive Response Technology systems used in clinical research.

Sergio Caldarelli, eConsent product manager at Kayentis, said: “Kayentis’ eConsent enables the rapid transformation of existing consent forms into an engaging digital experience.”

He added: “By instantaneously transforming conventional PDF consent forms into dynamic eConsent formats, our AI-powered configuration tool automates content extraction and the integration of multimedia and interactive features, significantly reducing setup time for sponsors and sites.”

Kayentis said the platform is intended for use across therapeutic areas and study types and is designed to support global clinical trial programmes. The company expects initial deployments during the second half of 2026, with wider adoption anticipated in 2027.

The launch reflects growing interest across the clinical research sector in digital consent technologies that aim to improve participant engagement while helping sponsors meet increasing regulatory and ethics committee expectations around informed consent quality.