Consent is the single most frequent cause of inspection findings. By fixing consent first, Oshimed transforms your most significant regulatory risk into your strongest operational asset.

1. Audit-Ready Proofs: Eliminating Regulatory Exposure

Remove the largest and quickest source of regulatory risk through immutable, time-stamped records of ICF versions and signatures. This ensures fewer findings and significantly faster, stress-free inspections.

2. Protocol Control: Preventing Downstream Breaches

Stop errors before they happen. By enforcing digital safeguards, critical steps—such as randomization and IMP dispensing—only proceed once all consent prerequisites are validated, effectively blocking downstream compliance breaches.

3. Operational Efficiency: Rapid ROI & Site Acceptance

Deliver rapid pilots that prove immediate value. By reducing source checks, queries, and corrective actions, Oshimed generates real savings in monitoring costs and streamlines the workflow for site staff, ensuring high adoption rates.

4. Privacy by Design: Total Compliance & Competitive Edge

Secure patient trust and CRO competitiveness. Patient data remains pseudonymized under strict site/IEC control, ensuring full GDPR compliance while providing a clear technological advantage in the clinical trial market.