ICH E6(R3)
Good Clinical Practice as revised in 2025: data governance, computerised systems, and the sponsor's oversight of the vendors who operate them. It can reach a device the trial merely relies on, not only devices the trial is investigating — a case many programmes have not yet assessed.
ALCOA+ on the Device: Device-Side Data Integrity in GCP
When a device captures trial data — a handset, a wearable, a home instrument or the gateway that relays them — attribution, time and protection against alteration are decided on the device, and no validated database can decide them later.
Open the paper →Consent on a Screen: The Regulatory Anatomy of eConsent
Why electronic informed consent sits across electronic signature, data protection and GCP / ethics — all at once — and why acceptance is not universal.
Open the paper →DeviceFit — fit-for-purpose validation
Technical, clinical and operational validation aligned to ISO 14971, IEC 62366-1, FDA QSR, EU MDR Annex I and ICH-GCP.
Open the paper →QMS Integration: Embedding DHT Controls across Sponsor and Vendor Quality Systems
Why the seam between GCP, ISO 13485 and software-lifecycle quality systems is where DHT control is won or lost.
Open the paper →Quality & Regulatory Assurance — service brochure
Quality and regulatory assurance — QMS design, regulatory strategy and ongoing compliance support for life-science organisations.
Open the paper →The Sponsor’s Accountability Map
A companion reading from the sponsor’s seat — what you can delegate the work of, and what you answer for regardless
Open the paper →You Can Delegate the Work, Not the Accountability: Vendor Qualification and Oversight under ICH E6(R3)
The sponsor’s duty to qualify and oversee its DHT vendors — distinct from who holds the economic-operator role.
Open the paper →ALCOA++ in the Age of Digital Health Technologies (Part 5/8)
Can your audit trail reconstruct every DHT data transformation from source to submission? Are firmware, algorithms, and databases synchronised under one…
Read the article →BYOD/eCOA in 2026: Timestamp Drift, Part 11/GDPR, and Audit Trails No One Wants to Own
What is “timestamp drift,” and how can a few minutes of clock deviation invalidate your eCOA endpoint data? Who actually owns the audit trail when…
Read the article →Best Practices for Usability Testing in DHTs
What makes usability testing a regulatory requirement for DHTs? How can poor usability compromise data integrity in decentralised trials? What are the most…
Read the article →Endpoints and Algorithms: How Firmware Can Break Your Study (Part 4/8)
Can a single firmware update, algorithm change or data-sync failure invalidate months of trial data? How did the FDA’s DHT guidances change who answers for endpoint traceability and version control?
Read the article →From Compliance Burden to Competitive Edge: How DHT Readiness Can Shorten the Path Through Review
Can building DHT compliance into trial design, rather than adding it later, mean fewer regulator questions and less rework? Is your compliance programme adding time to your timelines—or saving it?
Read the article →ICH GCP E6 (R3): When Digital Health Became Everyone’s Responsibility
For years, Digital Health Technologies sat in an awkward middle ground in clinical trials. Sponsors relied on them but didn’t always own them.
Read the article →ICH GCP E6 Is Changing — And Digital Health Technologies Are at the Centre
For years, Digital Health Technologies lived slightly outside the GCP spotlight. Useful? Yes. Innovative? Absolutely. GCP-critical? Not always. ICH GCP E6 (R3) changes that.
Read the article →Meet the New Digital Health Reality: How to Make Your DHT Trials Regulator-Ready in 2026
Will your digital endpoints still hold up under regulatory scrutiny in 2026? Could you explain your DHT data pipeline to an inspector—without guessing? Are…
Read the article →Reverse Logistics: Recovering DHTs Without Breaking Data Chains
How can sponsors eliminate “data breaks” across global DHT logistics networks? What are regulators expecting in traceability documentation under MDR and GCP?…
Read the article →Sponsor Oversight of Digital Health Technologies in Decentralised Clinical Trials: A Regulatory Guide
How do sponsors avoid becoming “accidental manufacturers” when deploying wearables in trials? What happens if a consumer-grade DHT fails to meet regulatory…
Read the article →The 2024 FDA DCT Guidance Decoded: 9 Operational Traps Sponsors Still Fall Into
What hidden operational traps are still tripping sponsors under the 2024 FDA DCT guidance? How can sponsors maintain investigator oversight across…
Read the article →The DHT Compliance Wake-Up Call: Why “Digital-Ready” Isn’t “Regulator-Ready” Anymore
Could you reconstruct any digital endpoint in your trial for an inspector—without opening PowerPoint? Is your DHT compliance actually regulator-ready, or…
Read the article →The DHT-Ready QMS: Integrating Device, Data, and Clinical Quality into One System (Part 2/8)
Does your QMS include design-history and validation records for every DHT you use? Are firmware, algorithms, and human-factors results governed under change…
Read the article →When a Digital Health Tool Becomes a Medical Device: The Hidden Regulatory Roles No One Told You About
If your digital health tool is already collecting endpoint data, are you absolutely sure regulators don’t see it as a medical device? Who’s carrying the…
Read the article →“It’s Just a Phone”
Did you know a consumer smartphone can trigger four separate regulatory frameworks the moment it touches a clinical endpoint? Why do so many sponsors fail…
Read the article →A document appears here because it names ICH E6(R3) in its own text. Nothing is inferred: this is what we have actually written about it.