Project Scope |
Scope is limited to digital biomarkers usage in Clinical TrialsThe project will introduce and identify the current state of topics relating to the usage of digital health technologies in clinical trials and regulatory submissions:
The project will also provide a common platform to discuss regulatory guidance around DHT. |
Problem Statement |
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Digital biomarkers |
cannot be explained without providing context to the larger eco-system of digital health technology (DHT). Digital health technology has been growing rapidly in recent years, and this trend is expected to continue. The COVID-19 pandemic has also accelerated the adoption of digital health technologies as people have become more accustomed to receiving healthcare services remotely. |
Problem Impact |
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We are requesting to change the Digital Biomarker Working Group project with Digital Health Technology. Navigating the regulatory landscape for digital health technologies can be challenging. Companies need to be proactive in understanding the regulatory requirements that apply to their products and work closely with regulators to ensure they are meeting these requirements in a timely and efficient manner. |
Project Leads | |
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Vijay Pasapula |
, Cerus |
VPasapula@cerus.com | |
Unnat Patel |
, AnalysisMate |
unnat.patel@analysismate.com |
Nicola Newton, PHUSE Project Assistant |
Proposing to broaden scope to "Digital Health Technologies"
Q2 2023
Recruit additional members through call for volunteers
Q2 2023
Present poster at PHUSE/FDA CSS 2023
Q3 2023
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In the process of expanding scope to "Digital Health Technologies".
Sanofi
Subhayan Das
Zahra Karimaddini
Q3 2024 |
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Objectives & Deliverables | Timelines |
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Produce a poster / paper for US Connect | Q1 2024 |
Produce a White Paper | Q3 2024 |
Deliver a presentation at a PHUSE Single Day Event on DHTs | Q3 2023 |