Good Clinical Practice is on the Verixa roadmap
Clinical quality — protocol deviations, site oversight, and clinical data integrity — is where the AI evidence gap is widest. It is on the Verixa roadmap, not in Phase 1.
GCP is a roadmap commitment, not a live module. Verixa Phase 1 ships GMP Core today; GCP is planned for 2028+ and built on customer pull, not founder push.
The regulatory context we are designing for
CROs and sponsors operate primarily under GCP, and ICH E6(R3) raises the bar on risk-based quality and data integrity across sites. Verixa Phase 1 focuses on GMP Core; GCP is planned for Phase 3 (2028+), built when design-partner pull justifies the engineering investment.
ICH E6(R3)
Good Clinical Practice — risk-based quality and data integrity across trial conduct.
FDA 21 CFR Part 312
Investigational New Drug application requirements.
EU CTR 536/2014
European Clinical Trials Regulation.
ICH E8(R1)
General considerations for clinical studies and quality by design.
The Phase 1 foundations GCP will build on
The GMP Core architecture — schema-level audit trail, MIRA advisory + HITL, and the G-7 evidence pack — is designed to extend into GCP. None of it claims GCP coverage today.
Planned · not yet built
Good Clinical Practice
Schema-level audit trail
The schema-level audit trail — model version, prompt hash, retrieved evidence, HITL decision — extends to protocol-deviation and monitoring records.
MIRA advisory + HITL
MIRA’s advisory + human-in-the-loop pattern carries over: it can surface site-monitoring gaps for a qualified human to disposition.
G-7 evidence pack
The G-7 evidence-pack structure generalises from a GMP workflow to a clinical-quality workflow.
Per-tenant isolation & e-sign
Per-tenant data isolation and the e-signature audit objects apply to clinical records unchanged.
Live in Phase 1
GMP Core foundation
Every foundation above is already live and load-bearing in GMP Core. GCP reuses this architecture — it adds no GCP coverage today.
Express interest in the GCP roadmap
GCP is targeted for Phase 3 (2028+), pending customer pull. Express interest to help shape the GCP roadmap and to be considered first when the clinical-quality cohort opens.
Expressing interest is lead capture for a future phase — it is not an order, a demo request, or a claim that GCP is available.