Designed to bridge gap between comprehension and consent, Kayentis’ AI-enabled eConsent solution turns complex 30- to 50-page consent forms into simplified, multimedia guided experience, while reducing operational burden for sites and sponsors
Launch extends Kayentis’ patient-centric vision beyond data collection to very first interaction in clinical trial — informed consent process – making consent management easier for patients, sites and sponsors
Meylan, France, June 24, 2026 – Kayentis, a global leader in electronic Clinical Outcome Assessment (eCOA), today announces the launch of its interactive clinical trial consent module embedded into its eCOA platform. Designed to enhance understanding of clinical trial participation before enrollment, Kayentis’ AI-powered eConsent solution is also built to accelerate the transition from paper-based consent into a digital user-friendly experience.
Peer-reviewed research has shown that clinical trial participants tend to understand only a fraction of the information presented on consent forms, particularly around risk, randomization and the investigational nature of treatments. This gap between comprehension and consent may affect participant confidence and engagement, contributing to sponsors facing higher dropout rates, increased study complaints, and growing regulatory and ethics committee expectations around patient understanding.
Moreover, managing informed consent is one of the most critical and highly fragmented processes for sponsors in global clinical trials; where management of country-specific localization, translations, ethics committee-driven updates and re-consent workflows across multiple geographies are key requirements.
Building on its extensive experience in delivering patient-centric technologies, Kayentis improves patient understanding while reducing operational burden for sites – helping sponsors and CROs modernize informed consent faster, more efficiently and with greater impact on trial quality.
Kayentis’ AI-powered eConsent solution seamlessly transforms traditional consent forms into a multimedia guided experience, so that participants have a better grasp of study procedures, risks, benefits and commitments prior to giving consent. Patients can watch videos, explore unfamiliar terms through an interactive glossary, follow highlighted key information during consent discussions, test their understanding with comprehension questions and personalize the experience with accessibility settings on the device of their choice.
Guillaume Juge
CEO at Kayentis
“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.”
Available within Kayentis’ eCOA platform, the module offers sites a unified intuitive experience for managing consent, from initial enrollment through to re-consent. Built on the same principles of simplicity and ease-of-use that have made Kayentis’ eCOA highly rated by sites, this next-generation eConsent solution:
- Supports on-site remote and hybrid consent models (including paper back-up)
- Meets requirements for secure electronic records and signatures (21 CFR Part 11 compliant)
- Is designed for global deployment
- Integrates easily with any IRT systems (Interactive Response Technology) to connect solutions and simplify the end-to-end process
Sergio Caldarelli
eConsent Product Manager at Kayentis
“Kayentis’ eConsent enables the rapid transformation of existing consent forms into an engaging digital experience.
By instantaneously transforming conventional PDF consent forms into dynamic eConsent formats, our AI-powered configuration tool automates content extraction, significantly reducing setup time for sponsors and sites.”
Kayentis eConsent provides sponsors and CROs (Clinical Research Organizations) with a solution that can be deployed across any study type or therapeutic area, on a global scale. It accelerates implementation timelines, while simplifying the creation of re-consent materials, adaptations and translations that align with regional regulatory requirements, thus improving operational efficiency across the study lifecycle.
Initial study deployments of this next-generation eConsent solution are planned for the second half of 2026, with broader market rollout and adoption expected to accelerate in 2027.
Looking ahead, Kayentis sees informed consent evolving beyond a study-specific process toward a sponsor-centric approach. The company aims to further enhance its configuration capabilities to help sponsors manage consent templates and adaptations consistently across multiple studies, while preserving their existing governance models.
About Kayentis
Kayentis is a global leader in electronic Clinical Outcome Assessment (eCOA) and Decentralized Clinical Trial solutions. For over 20 years, it has partnered with pharma, biotechs and CROs in streamlining data collection and enhancing data quality across clinical trials worldwide. To date, Kayentis has supported more than 400 clinical trials in over 90 countries. Its expertise spans all clinical phases (I–IV) and more than 200 indications across 20+ therapeutic areas, delivering a comprehensive, science-driven and patient-centric suite of services. Operating across the US, Europe and Asia, Kayentis is recognized for its commitment to quality, innovation and operational excellence. With a 95.9% client recommendation rate in 2026, consistently rating above 90% over the past five years, Kayentis continuously adapts its solutions to meet the growing complexity of clinical trials and to improve outcomes for sponsors, sites and patients alike.
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