For sponsors and R&D
Avoidable amendments start as unsourced assumptions. Antevra makes every claim cited and every decision owned, and gives you data to build on months earlier.
Running BE/BA studies instead? See For BE/BA CROs.
What each role gets
- Clinical development lead
- A source-linked register of the protocol’s facts and assumptions, each with an evidence status, an owner and a decision.
- Biostatistician
- Conflict detection across sources, and a dataset to dry-run the analysis on.
- Statistical programming lead
- An SDTM-shaped synthetic dataset, with a validation report and full traceability, before first patient in.
- Data manager
- The traceability chain: protocol sentence → design value → CRF field → SDTM variable.
- Regulatory, QA, AI governance
- Append-only decisions, immutable source revisions, and a dossier recording which model ran each stage.