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September 9, 2021

Digital Health Vendor Assessment for Clinical Trials

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Digital Health Vendor Assessment for Clinical Trials

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

Authors

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.

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:


We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

Request an Introduction

We can provide an introduction on your behalf so that you can contact them directly with any questions/queries on this topic. Simply click on the link below to request an introduction.

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Featuring
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Sprint: Prescription DTx - Commercialization Models & Adoption

21st September @ 10:45AM EDT

Join this series of 2 meetings to discuss with other senior leaders Commercialization Models & Adoption in Prescription DTx. Limited spaces available so apply now to secure your place in the conversation.

Featuring
Lee Shapiro
Lee Shapiro
Managing Partner, 7wire Ventures
Michael Pace
Michael Pace
Founder and President at PalmHealth.co
Featuring
Lee Shapiro
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Managing Partner, 7wire Ventures
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DTx - Medtech partnerships

23rd September @ 10:45AM EDT

Join us in this informal conversation with senior leaders how DTx companies should think about Medtech as the appropriate partner and vice versa. Apply now to connect with peers and network with new people.

Featuring
Lisa Suennen
Lisa Suennen
Group Leader, Manatt Ventures
Sean Cheng
Sean Cheng
VC Investor, Philips Ventures
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Lisa Suennen
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Group Leader, Manatt Ventures
Sean Cheng
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VC Investor, Philips Ventures
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DTx in Mental Health: Scaling access to care - Fireside chat with Big Health Co-founder & CEO Peter Hames

23rd September @ 10:00AM EDT

Do you want to learn from one of the top DTx companies in mental health? Join us in this exclusive fireside chat with Peter Hames, co-Founder and CEO at Big Health, where we will talk about the early days of DTx in mental health, Big Health’s differentiated commercialization models, industry leading clinical evidence and the significant opportunity to address the mental health crisis by expanding access to mental health care.

Featuring
Peter Hames
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Co-Founder & CEO of Big Health
Martin Kelly
Martin Kelly
Co-founder & CEO, HealthXL
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Peter Hames
Peter Hames
Co-Founder & CEO of Big Health
Martin Kelly
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