Articles tagged with “digital-health-technologies”

FDA Digitally Derived Measures in Clinical Trials

A 2026 evidence matrix for FDA digitally derived measures, covering endpoint roles, verification, validation, missingness, change control, and a stride-length example.

24 min read

9/19/2026

fda digitally derived measures digital endpoints clinical trials digital biomarkers sensor-based endpoints analytical validation clinical validation digital health technologies change control

ICH E6(R3) Annex 2: DCT, Pragmatic & RWD Crosswalk

A 2026 implementation crosswalk for ICH E6(R3) Annex 2, covering the 15 January 2027 EU date, remote consent, DHT and EHR controls, RWD fitness, and control ownership.

22 min read

9/19/2026

ich e6(r3) annex 2 decentralized clinical trials pragmatic clinical trials real world data good clinical practice digital health technologies clinical data governance eclinical architecture rwd fitness for purpose

FDA AI Guidance 2026: Drug Manufacturing & Digital Health

Analyze the FDA CDER 2026 guidance pipeline for artificial intelligence in drug manufacturing and digital health technologies in pharmaceutical development.

35 min read

4/10/2026

fda guidance artificial intelligence drug manufacturing digital health technologies cder 2026 pharma regulatory frame initiative machine learning

Decentralized Clinical Trials: Platform & Software Guide

A comprehensive guide to decentralized clinical trials (DCTs). Review hybrid trial technologies, compare software platforms, and explore implementation steps.

30 min read

3/5/2026

decentralized clinical trials dct software clinical trial platforms hybrid trials remote data collection digital health technologies econsent