Data Management Dataset-JSON, USDM and IDMP arrive in the same quarter The XPT transport, the document-shaped protocol and the unstructured product dictionary are all being replaced at once — and the migration paths do not line up.
Data Management FDA says yes to R, no to your Docker image Pilot 4's review letter, J&J's hybrid pipeline, and a Pinnacle 21 gap together draw the real 2026 boundary between what R submissions can do and what reviewers can actually open.
Data Management CDISC's quiet pivot from files to a data-centric stack Dataset-JSON now ships with an API standard. The interesting question is whether the metadata underneath is consistent enough for anything to actually query it.
Medical Writing CONSORT, SPIRIT, and ICMJE All Update at Once — Your Templates Can't Keep Up Three foundational reporting standards refreshed inside a year, and none of them harmonises with ICH E3. The confluence is the problem — not any single checklist change.
Data Management CDISC's Expanding Perimeter Is Outrunning Its Implementation Ecosystem SDTM was built for interventional trials; FDA is now formalising its use for observational data, while Dataset-JSON v1.1 awaits regulatory acceptance it doesn't yet have.
Medical Writing CONSORT 2025's New Statistical Items Land in Statisticians' Laps Four reporting standards updated in thirteen months — the operational squeeze falls hardest on the SAP, the missing-data section, and the TLF shell your team built to CONSORT 2010.
Data Management FDA's R Pilot Review Letters: The Honest Gap Between Proof-of-Concept and Reviewer-Ready FDA's formal review letters for Pilots 4 and 5 are the first detailed public account of which R submission tooling the agency's IT environment can actually run today.