Digital Health Vendor Assessment for Clinical Trials

An open-source guide to facilitate vendor qualification for clinical trials

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Authors

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In this blog we present an open-source guide, the output of a pre-competitive working group:

Erwin De beuckelaer (Director Innovative Capabilities at Janssen)

JJ Ferrer (Executive Director, Head of Digital Strategy Oncology at Bayer Pharmaceuticals)

Kris Karson (Co-Founder & CEO at Phebe Health)

Lorcan Walsh (Digital Endpoint Capability Centre Lead at Novartis)

Philip-Moritz Russmeyer (Founder & CEO at FITFILE)

Rachel Chasse (Director of Innovation at the Digital Medicine Society - DiMe)

Shwen Gwee (VP and Head of Global Digital Strategy at Bristol Myers Squibb)

Tim Ruckh (Associate Director, devices and sensors at AstraZeneca)

Elisa Frenz (HealthXL Consultant)

Chandana Fitzgerald (Chief Medical Officer at HealthXL).

The guide has been peer reviewed by:

Hiromasa Mori (Head of Early Asset Technologies at UCB)

Benjamin Vandendriessche (Chief Medical Officer at Byteflies)

*All the authors participated in this pre-competitive working group as individuals, not representing their company's views on the matter.

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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 that would cover essential operational due diligence. In the intervening six months, this group has convened to create an open-source operational due diligence guide to facilitate vendor qualification*. Using 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 guide 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.

Click on the button below to download the 'Digital Health Vendor Assessment for Clinical Trials' guide

‍*This document is a Recommendation / Guide / Best-case scenario, non binding. We have excluded clinical evidence generation guidance and in-depth IT system evaluation.

Watch our latest webinar, where the group walked us through the guide:

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Digital Health Vendor Assessment for Clinical Trials