Resources for clinical innovation

Your source of practical guides, expert webinars, interesting articles, industry events and opinion pieces to accelerate digital endpoint research and collaboration

Digital measures readiness diagnostic

The Gap Map

A free self-assessment across seven areas - from how a measure gets chosen through to whether the next program can reuse what the last one built. 

  • Ten minutes, free to use, no login
  • A report on screen and as a PDF,
    showing where you stand and what to do first
  • Your answers stay yours unless you choose to share them
Start the diagnostic Find out more
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All categories Articles Case studies Digital endpoints Digital Measurement Solution Events Nocturnal Monitoring Opinion Piece Physical Activity Regulatory ROI Sleep Quality speech/cognition
Articles Regulatory

From grey zone to guideline: what ICH E6(R3) Annex 2 means for digital health technologies

On 3 June 2026, decentralised trials, pragmatic designs and real-world data got their own good clinical practice rulebook. For the wearables, sensors and apps that power modern trials, it is a...
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Mireille Muller
Regulatory

Is Your Technology a Medical Device?

Why is this important? Understanding if your digital health technology (DHT) qualifies as a medical device is essential for determining its regulatory pathway, market access strategy and compliance...
Team DEEP Measures
Regulatory

The Measure Comes First: Rethinking Validation for Digital Health Technology

Start with the measure, not the digital health technology (DHT) Define the measure first: its Context of Use (the population, the concept of interest, and the decision it must support) dictates what...
Team DEEP Measures
Regulatory

We answered the FDA’s RFI on digital health technologies - here’s what we said, and why it matters to you.

The short version On March 31, 2026, the FDA issued a Request for Information (RFI) - Advancing the Use of Digital Health Technologies in Clinical Investigations for Drugs and Biological Products...
Team DEEP Measures
Case studies Sleep Quality Nocturnal Monitoring Regulatory

Build Once, Use Everywhere: How the DEEP–EMA Pilot Reimagines Digital Measure Qualification

What if digital measures could be defined once, reused across technologies, and seamlessly extended to new clinical contexts? The DEEP–EFPIA–EMA pilot offers the first real‑world glimpse of how that...
Team DEEP Measures
Digital endpoints Case studies Regulatory

From Measurement Concept to Submission-Ready Data: A CDISC Standards Proof of Concept

The DEEP Stack model was designed to structure digital measures from concept through to clinical evidence. But how well does that structure translate into the data standards required for regulatory...
Team DEEP Measures