Platform updates, milestone announcements, and notes from the team. Updated as things happen.
Latest
After two years of iterative development across nine versions, Clinly v9 is the first release we consider production-ready for real study use. This version includes the full automated protocol extraction engine, HITL review workflow, visit matrix, immutable PostgreSQL audit trail, and regulatory export engine — all tested on real protocols.
9
Major versions since 2023
12+
Real protocols validated
87.8%
First-pass extraction accuracy
The platform is available for pilot customers now. Book a demo call → Or explore the live demo →
Update history
Q1 2026
Studies configured in Clinly can now be exported directly as Rave ALS (Architect Loader Spreadsheet) format, enabling CROs that run Medidata Rave as their primary EDC to use Clinly for protocol parsing and then import into their existing infrastructure.
Electronic signatures for CDM review actions — including HITL sign-off and data lock — are now fully implemented and aligned with 21 CFR Part 11 requirements. Each signature is cryptographically bound to its record and logged in the append-only audit trail.
We're in active conversations with CROs about paid pilot engagements for Q2 2026. These are pre-revenue discussions — nothing signed yet — but they're based on live platform demonstrations using real protocol documents the CROs provided. See traction details →
Q4 2025
The extraction engine was tested across therapeutic areas beyond the initial oncology focus — including cardiology (hypertension, heart failure) and CNS (depression, Alzheimer's). Accuracy held above 85% first-pass across all three areas, with CDISC domain coverage extending to MH, PR, and SU domains.
The audit log was moved from application-level logging to PostgreSQL trigger-based enforcement. This means the application cannot suppress, modify, or delete audit entries — they're written below the application layer. A key milestone for regulatory defensibility.
The backend was unified under a single Node.js/TypeScript service, replacing the fragmented v8 architecture. This enabled consistent auth middleware, structured API contracts, and a reliable foundation for the e-signature and audit trail work that followed.
Earlier milestones
v7 + v8: Visit matrix visualisation, multi-arm protocol support, SDTM domain mapping expanded to 7 domains (DM, AE, VS, CM, LB, EX, DS).
v5 + v6: First working extraction engine validated on a real 248-page Phase III oncology protocol. CRF library and query management system built.
v3 + v4: CDISC CDASH domain structure implemented. First database schema capable of representing a real clinical trial's data model.
v1 + v2: Initial concept and prototype. Identified the core problem from firsthand industry experience: EDC setup as a structural bottleneck in clinical trial startup.
Live milestones — updated as they happen.
We send occasional updates when meaningful things happen — new features, pilot results, and honest reflections on what we're learning. No marketing drip.
Or reach us directly at hello@clinly.app