Protocol v2.3. The one before the last amendment. In the shared drive. Or was it the inbox? Or the folder someone renamed? Regulatory inspection in 48 hours.
Ariadne Locker is a fully validated electronic data capture and study management platform — built for teams who need more than a legacy EDC but can't afford six months of IT validation. Patient eConsent, block randomisation, multi-site management, and a tamper-evident audit trail that satisfies GCP, 21 CFR Part 11, and regulatory inspection — without writing a single line of code. Data flows in directly from Sculptor.
Locker gives every study document a permanent, versioned home — and makes sure your team can find it when it matters most.
Store all study documents in one place — protocols, amendments, consent forms, investigator brochures, regulatory correspondence — with role-based access control.
Every document version tracked with upload timestamp, user identity, and mandatory change reason. The right version is always findable; old versions are never deleted.
Data collected in Ariadne Sculptor flows directly into Locker. eCRF datasets automatically linked to the corresponding study record — no manual transfer.
Capture electronic signatures at the point of document upload. Chain of custody established from day one. 21 CFR Part 11 compliant.
Search across document names, metadata, and content. Find what you need in seconds. Filters by study, site, document type, date, and status.
Generate a complete, formatted inspection pack with one click. Documents collated, versioned, and timestamped — ready for regulatory auditors.
Investigators, coordinators, monitors, and sponsors each see only what they should. Study-level and site-level access controls with full audit trail.
Export study data in FHIR R4 format. Integrates with downstream regulatory and clinical data systems without custom ETL.
Built for regulated environments. Audit trail, e-signatures, version control, and access logs satisfy GCP, ICH E6(R2), and 21 CFR Part 11 requirements.
Book a 30-minute demo and we'll walk through your study document workflow — or open Locker directly and start organising your first study today.
£2,400/yr · up to 5 users · Sculptor + Locker bundle £4,200/yr (save £600)