Copyright 2021 HealthXL

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 

Fill the form to download your free 63-page Guidance on 'Digital Health Vendor Assessment for Clinical Trials'

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

Get your free 63-page guidance document now

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


*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