A dated timeline, reviewed monthly
Editorially owned. Each entry needs a primary-source link and a date before it's added — this is a status tracker, not a marketing claim.
ICH E6(R3) finalized
The revised Good Clinical Practice guideline puts sponsor oversight of delegated activities squarely back on the sponsor — the basis for the CRO/vendor oversight decision on our Biotech & Pharma page.
FDA–EMA AI principles
Joint FDA–EMA principles on AI in the drug development lifecycle set shared expectations for context-of-use and human oversight — the frame our Technology & AI Vendors work is built on.
FDA launches Real-Time Clinical Trials (RTCT)
Proof-of-concept trials and a Request for Information move the industry from periodic data batches toward continuous signal flow. The initiative's two most visible champions have since left FDA — RTCT is an accelerant for the direction of travel, not a settled program.
ICH M11 finalized
The harmonized protocol template and technical specification standardizes protocol structure — the basis for the structured-protocol option on our Protocol & Trial Design work.
Operation TrialBlazer & the Expedited IND proposal
HHS launches Operation TrialBlazer, including a proposed Expedited IND pilot in which CROs and medical centers could pre-review Phase 1 protocols, alongside a draft master-protocols framework.
Last reviewed: September 2026. This tracker never implies AyurDatta is a pilot participant or a Qualified Research Institution.
Three seats, three sets of stakes
Sponsors
Data flows and signal definitions need to be agreed before continuous review is possible — and a named physician still has to make the call on what a real-time signal means.
See Biotech & Pharma →CROs
A Qualified Research Institution role under Expedited IND would need on-demand physician-level protocol and IND review — capability most CROs don't carry in-house today.
See CRO & FSP enablement →Technology & AI vendors
Continuous data flow raises the bar on validated, human-overseen AI — the FDA–EMA principles are the standard your buyers will hold you to.
See Technology & AI Vendors →Six questions to answer before you need to
- ✓Do you know where every safety-relevant data flow originates and where it lands?
- ✓Are your signal definitions (CRS, ICANS, DLTs, or equivalent) agreed and documented before the first patient is dosed?
- ✓Is a named, credentialed physician assigned to review flagged signals — not just a team?
- ✓Does every material decision generate an audit trail as it happens, not reconstructed later?
- ✓Are your eClinical decisions being made at IND, not bolted on after protocol lock?
- ✓Is your protocol structured to ICH M11, or will it need retrofitting for the next submission?
Answer honestly and want a graded view? Take the Readiness Check →
Read the briefing, and where we've gone on the record
Continuous by Design
FDA's Real-Time Clinical Trials initiative: the history, the industry response, and AyurDatta's four-pillar readiness framework with a 90-day action plan.
Download the briefing →Our comment to FDA
Submitted June 25, 2026 in response to Docket FDA-2026-N-4390 — why every AI-assisted safety output needs a matching, documented human decision.
Read our comment to FDA →The obligation was never the pilot's to carry.
Sponsor accountability and documented physician judgment remain your obligation regardless of which pilots run, which proposals advance, or which champions move on. That is the constant this entire hub is built around.