HealthXL and a consortium of representative stakeholders from across the digital health ecosystem are working to advance the understanding and adoption of digital health products used in clinical trials.
To reduce variable implementations of similar quality standards, the group began in Q4 2020 to work towards an open-source industry guidance questionnaire to cover essential operational due diligence. In the intervening six months, this group has convened to create an open-source operational due diligence guidance to facilitate vendor qualification.
With a standardized template, vendors will have a response package prepared with the majority of expected documentation in a format that sponsors are ready to accept and review. While this framework is meant to serve as a guidance for industry, it can easily be adapted to suit individual needs and specifications and can also be adapted for usage in non-clinical trials and other cases
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*This document is a recommendation / guide / best - case scenario, non binding. We have excluded clinical evidence generation guidance and in depth IT system evaluation
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An open-source guidance to facilitate vendor qualification for clinical trials
Authors
*All the authors participated in this pre-competitive working group as
individuals, not representing their company's views on the matter.
Chandana Fitzgerald
JJ Ferrer
Philip-Moritz Russmeyer
Chief Medical Officer, HealthXL
Executive Director, Head of Digital Strategy Oncology at Bayer Pharmaceutical
Founder & CEO at FITFILE
Lorcan Walsh
Digital Endpoint Capability Centre Lead at Novartis
Erwin De beuckelaer
Tim Ruckh
Elisa Frenz
Kris Karson
Director Innovative Capabilities at Janssen
Co-Founder & CEO at Phebe Health
Associate Director, devices and sensors at AstraZeneca
HealthXL Consultant
Peer Review by
Rachel Chasse
Director of Innovation at the Digital Medicine Society - DiMe
Shwen Gwee
VP and Head of Global Digital Strategy at Bristol Myers Squibb
Benjamin Vandendriessche
Hiromasa Mori
Head of Early Asset Technologies at UCB
Chief Medical Officer at Byteflies
Digital Health Vendor Assessment For Clinical Trials
Watch our latest webinar, where the group walked us through the guide