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 current module. Verixa Phase 1 focuses on GMP Core today; GCP is planned for 2028+ and built on customer pull, not founder push.
Clinical-stage biotechs carrying an active US IND/NDA path, and CROs running multi-sponsor portfolios — organizations where clinical quality evidence must satisfy a sponsor, an IRB and an inspector at the same time, and where AI assistance in quality work needs a provable human boundary before any regulator asks.
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.
What this demands of a quality system
Protocol deviations managed as quality events — captured, classified by impact on subject safety and data integrity, investigated and closed with evidence — not logged in a spreadsheet per study.
TMF completeness that is provably current — not reconstructed the month before an inspection.
Sponsor / CRO / site oversight — documented, risk-based oversight of work performed by parties you don’t control, with accountability that survives handoffs.
Data integrity across systems — ALCOA+ applied across EDC, eTMF, safety and quality systems that were never designed to agree with each other.
The Phase 1 foundations GCP will build on
The Phase 1 GMP Core architecture — schema-level audit trail, MIRA advisory + HITL, and Evidence & Validation — 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.
Evidence & Validation
The Evidence & Validation 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 (controls under verification) apply to clinical records unchanged.
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.
On the GCP roadmap — planned, not yet built
These are design intentions for the GCP roadmap, phrased as intent — not capability claims. Nothing here is available today; each is built only when design-partner pull justifies the engineering.
Clinical quality events and protocol deviation workflows on the governed spine.
Study-level oversight and escalation paths for sponsor/CRO/site accountability.
TMF-readiness evidence on the sealed-pack model.
AI assistance governed exactly as in GMP Core: advisory, labelled, never autonomous in GxP-critical decisions.
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.