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.
Allucent’s safety specialists have intimate knowledge of regulatory requirements across geographies, and provide a broad spectrum of pharmacovigilance services. We use ArisGlobal LifeSphere, a fully validated safety database systems compliant with 21-CFR part 11 and E2B(R3), to collect, analyze, and report safety information.
Our safety experts provide the following services:
- Optimized design of safety-related eCRFs and protocol sections
- Triage and processing of incoming serious adverse events (SAEs) and suspected unexpected serious adverse reactions (SUSARs)
- Narrative writing and issuance of queries as needed
- Preparation of CIOMS and Medwatch forms
- Global expedited case reporting (EU and U.S.)
- Aggregated report preparation and reporting (e.g., DSUR, semiannual line listings)
- Monthly compliance and status reporting
- SAE reconciliation
- Unblinding services
- Global safety database setup and maintenance
- Sponsor registration with EudraVigilance
- XEVMPD entry and maintenance
- Please note: Allucent pharmacovigilance managers are certified by EMA as EVWEB and XEVMPD users in the EudraVigilance system.
- We will function as the Responsible Person (RP) for EudraVigilance (EU) and Regulatory Contact (U.S.), if required.
- Controlled real-time access to the safety database for authorized sponsor representatives
- Safety Gateway option: direct communication between clinical database (if Medidata Rave is used) and safety database; no need for duplication of data entry and SAE reconciliation