Compliance & Risk Management
Regulatory Affairs, QA & Risk-Sharing
Audit-ready in every market you enter — and a partner that shares the risk.
Regulatory strategy, an independently structured QMS, and a Risk-Sharing Program that targets every trial-related cause of failure.
What’s included
- Regulatory strategy, submissions and agency interactions; EC/IRB approvals
- Independently structured QMS: data integrity, process standardization, risk-based audits
- Pharmacovigilance and safety (ADR) reporting
- Shared-risk, milestone-based costing — and private co-investment in clinical development for the right programs
Why CEBIS
Only ~14% of drugs entering clinical trials win FDA approval. Our Risk-Sharing Program addresses every trial-related cause of failure — poor study design, ineffective site selection, eligibility, low recruitment, low retention, poor execution and poor risk management — each with a defined CEBIS solution. Quality is an independently structured system, so audits confirm what’s already true, and project information is kept in CTIS, accessible to the sponsor at any time.