Legacy eCRF platforms take months to validate, cost a fortune to change, and still somehow require a paper backup. Teams give up and use spreadsheets. Data ends up in inboxes.
Ariadne Sculptor is a compliance-ready eCRF builder your team can actually use. Drag-and-drop form design, 21 CFR Part 11 audit trail, electronic signatures, FHIR R4 export — built for Medical Affairs and clinical research teams without a dedicated IT function.
Sculptor takes your team from blank-page form design to validated, inspection-ready data collection — without involving IT at any stage.
Build case report forms visually without writing a line of code. Add fields, sections, branching logic, and validation rules with a clean drag-and-drop interface.
Pre-built ICH E6(R2) compliant templates for consent, adverse events, concomitant medications, protocol deviations, and more. Ready to deploy in minutes.
Electronic records, e-signatures, and audit trails that satisfy FDA 21 CFR Part 11 and GAMP 5 requirements. Built-in from day one — not bolted on.
Capture legally valid electronic signatures from investigators, coordinators, and approvers. Sign-off workflows configurable per form and per role.
Show or hide questions based on previous answers. Build adaptive forms that reduce data entry burden and prevent impossible responses.
Every form version tracked with timestamps, change reasons, and user attribution. Roll back at any time. Full change history available for regulatory inspection.
Export collected data in FHIR R4 format or as a standard JSON pipeline. Integrates with downstream clinical systems without custom ETL.
Data collected in Sculptor flows directly into Ariadne Locker. Clinical datasets attached automatically to the corresponding study record.
Row-level security scopes all data to your institution. No cross-tenant access. GDPR-compliant with EU data residency.
Book a 30-minute demo and we'll walk through your data collection use case — or open Sculptor directly and start building your first form today.
£2,400/yr · up to 5 users · Sculptor + Locker bundle £4,200/yr (save £600)