Pharmacovigilance
Through our in-house capabilities we can provide pharmacovigilance (PV) services for your programs. Whether you require basic event reporting or “full service” PV capabilities, WEP has the expertise to support your monitoring and reporting needs.
The WEP Pharmacovigilance (PV) team has over a decade of experience providing PV services for Clinical Trials, Expanded Access Programs, and other Post-Trial Access Programs.
We understand that finding a trusted and cost-effective partner for your safety reporting is of great importance. We work closely with each of our Sponsors to understand their unique needs and design tailored safety management plans (SMPs) that are end-to-end and fully compliant:
- Across all our programs, our approach is pragmatic, flexible and efficient
- Our PV solutions are delivered keeping the patients, physicians and Sponsor as the primary focuses
- We ensure SMPs adhere to the standards required by all regulatory agencies in scope
Why work with WEP
- Cost-effective solution
- Automatic data transfer
- Reduced data entry effort
- Reduced burden to site
How We Manage Our PV Programs
- Prepare and finalize Safety Management Plan (SMP)
- Set-up program-specific Argus enterprise
- Support program start-up meetings
- Determine program-specific Regulatory submission requirements
- Receive and process SAEs
- Provide safety updates / listings on a regular basis
- SAE reconciliation between Argus and EDC
- Support program meetings
- Annual/Periodic Reporting (DSUR, Line Listings, etc.)
- Track safety submissions
- Finalize / Close SAEs
- Final SAE reconciliation
- File final safety documents in program eTMF
- Provide program safety data to Sponsor
WEP Full-Service Pharmacovigilance
- Provide Safety Database (Argus version 8.2.3.1) Pending update Summer 2024
- PV Project Management
- Initial and follow-up SAE case processing and review
- Medical Review and Follow up SAEs
- ICSR/SUSAR Case Finalization and Submission
- Safety Report Tracking
- DSUR Listing/Reports
- Clinical/Safety Database Reconciliation
- Monthly Safety Listings