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This page details how Loopa gives sponsors continuous compliance visibility across vendors and protocols. Tell us a bit about yourself and we'll unlock it instantly.
This page details how Loopa gives sponsors continuous compliance visibility across vendors and protocols. Tell us a bit about yourself and we'll unlock it instantly.
Continuous oversight for clinical trials. From source document to EDC to audit-ready report.
The cost of monitoring scales linearly. The cost of missing a deviation compounds.
From document ingestion to audit-ready reporting. Each stage maps to specific ICH E6(R3) and ALCOA+ requirements.
Upload a protocol PDF. The AI extracts clinical requirements and parses the Schedule of Events into a structured visit-by-assessment matrix.
A 5-step evidence-anchored RAG pipeline scores every source document against protocol requirements. Low-confidence items route to human review with mandatory evidence citations.
Direct API integration with Medidata RAVE and Oracle InForm compares source data against EDC entries automatically. The same source-to-CRF reconciliation a CRA performs on-site, running continuously.
The AI classifies each finding as Critical, Major, or Minor based on impact to Critical to Quality factors. Risk proportionality, not uniform escalation.
Auto-generated deviation records link each finding to the affected CtQ factor, study, site, patient, and visit. Each record carries a regulatory citation index mapped to R3, ALCOA+, and 21 CFR Part 11.
Conditional CAPA triggers based on deviation severity and recurrence patterns. Human overrides require a documented rationale; both assessments remain in the audit trail.
One-click export of every finding, deviation, CAPA, and resolution status across the study. Inspection-ready at any point, not assembled retroactively before a submission.
The complete monitoring workflow: source-to-protocol scoring, source-to-EDC reconciliation, and audit-ready reporting. Continuous. Automated. Inspection-ready.
ICH E6(R3) Section 3.11.4.2 explicitly validates centralized monitoring as the sole oversight method for a clinical trial. Loopa is that infrastructure.
ICH E6(R3) was finalized in January 2025, with the EU effective date of July 2025 and FDA final guidance published September 2025. It is the most significant overhaul of Good Clinical Practice in nearly 30 years.
R3 shifts from a rules-based, prescriptive framework to a principles-based, outcomes-focused approach. Quality by Design replaces quality by inspection.
For the first time, R3 explicitly validates centralized monitoring as the sole oversight method for a clinical trial (Section 3.11.4.2). It also creates a standalone Data Governance section (Section 4) requiring audit trails, UTC timestamps, role-based access controls, and system validation.
Every record in the Loopa platform meets all nine ALCOA+ data integrity principles: Attributable, Legible, Contemporaneous, Original, Accurate, Complete, Consistent, Enduring, and Available.
| Loopa Capability | R3 Section | ALCOA+ Principles |
|---|---|---|
| Protocol-aware AI compliance scoring | Principle 8, Section 3.9.3 | Accurate, Complete |
| Source-to-EDC data reconciliation | Section 3.11.4.2, Section 4 | Consistent, Accurate |
| Findings severity classification | Principles 6 and 7, Section 3.4 | Accurate |
| Full audit trail on all actions | Section 4.2 | Attributable, Complete |
| UTC server-side timestamps | Section 4.2 | Contemporaneous |
| Role-based access and tenant isolation | Section 4.3 | Attributable, Available |
| Source document preservation | Section 4.1 | Original, Enduring |
| Cross-site pattern detection | Section 3.11.4.2 | Consistent |
| Audit-readiness report export | Section 3.11.4.6.c | Available, Complete |
Same oversight. A fraction of the cost.
Estimates based on $80 per patient visit reviewed and an average of 6 subjects reviewed per CRO monitoring visit. Actual costs vary by protocol complexity, therapeutic area, and monitoring plan.
We built Loopa for a specific problem we lived with firsthand. If you are running trials and want to see what continuous compliance intelligence looks like on your data, we would like to show you.
Everything on this page is shared in confidence.