Governance and oversight for trials
Clinical research teams already hold participant data in their own clinical data and trial management systems. CGRC AI sits alongside them as the governance layer. It does not hold participant-level data. It tracks the oversight around the trial, so quality, risk and approvals can be seen and evidenced in one place.
What it covers
- Trial register. Protocol, phase, sponsor, indication, status and linked controls, with essential documents attached as evidence.
- Sites. Site status, principal investigator, activation, enrolment target and actual counts, and ethics approval references with expiry dates. Approvals past their expiry date appear as overdue items.
- Protocol deviations. Minor, major and critical deviations with dates, root cause, corrective action, whether they were reported to the ethics committee, and follow-up actions.
- Monitoring visits. Initiation, routine and close-out visits with findings and follow-up.
- Risk-based quality management. Fields to record critical-to-quality factors, risk assessment and the use of decentralised elements, in line with the direction of ICH E6(R3).
- Approvals with proof of who signed. A signer is asked to confirm their identity again at the moment of signing, and the signature is tied to the exact content of the record at that time. Any later change to the record is visible.
- AI systems register. An inventory of the AI systems an organisation uses or builds, with risk tier, human oversight and review dates, useful as AI regulation develops.
What we do and do not claim
CGRC AI provides the software capabilities that electronic signature rules look for, such as re-authentication, a signature tied to record content and a full audit trail. It does not make an organisation compliant. Validation, procedures and training remain the organisation's responsibility, and we say so plainly. We hold no formal certifications yet.
AI that helps and people who decide
The AI can draft a deviation record from a description, summarise a trial's oversight picture and point to earlier similar cases. It always shows what it used, and a person approves every change.
Common questions
Does CGRC AI hold clinical trial participant data?
No. It is for governance and oversight. Enrolment is recorded as plain counts, never as participant records.
Does it replace our clinical trial management system?
No. It sits alongside it as the governance and oversight layer.
Are the electronic signatures compliant with 21 CFR Part 11?
CGRC AI provides capabilities that such rules look for, including re-authentication at signing and a signature tied to record content. Compliance also depends on your own validation, procedures and training, so we do not claim compliance on your behalf.
Is CGRC AI certified?
Not yet. CGRC AI is at pilot stage and holds no formal certifications.
Related pages
Interested in being a pilot partner? Get in touch and we will arrange a conversation.
Last updated 12 October 2026.