Patient safety is one of the most important components of drug development. Identifying the safety profile and assessing risk/benefit of a new compound in a timely and responsible manner contribute to the protection of patients’ and public health. Complying with the quickly evolving legal requirements for pharmacovigilance is essential.
ODC’s safety specialists have thorough knowledge of regulatory requirements across geographies and provide a broad spectrum of high standard pharmacovigilance services, using fully validated 21-CFR part 11 and E2B compliant safety database systems to collect, analyze, and report safety information.
Our safety experts provide the following services:
- Optimize the design of safety-related eCRFs and protocol sections
- Function as the Responsible Person (RP) for EudraVigilance (EU)
- Process incoming serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs)
- Issue queries as needed
- Preparation of CIOMS and Medwatch forms
- Set-up of Safety Management Plan
- Global expedited case reporting (EU and U.S.)
- Aggregate report preparation and reporting (e.g., DSUR, semi-annual line listings)
- Monthly compliance and status reporting
- SAE reconciliation
- Unblinding services
- Global safety database setup and maintenance
- Registering sponsors with EudraVigilance