Pharmacovigilance
Through our in-house expertise and capabilities, we can provide pharmacovigilance services for your programs. We offer end-to-end solutions to help you navigate the complex landscape of drug safety across every stage of the clinical development journey, including:
Phase 1-4 Clinical Trials
Expanded Access Programs
Post-Trail Access Programs
We integrate cutting-edge technology and deep regulatory knowledge to deliver timely and accurate insights to support your monitoring and reporting needs.
Our pharmacovigilance (PV) team works closely each Sponsor 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
Our Pharmacovigilance Services
- Provide Safety Database (Argus version 8.2.3.1)
- 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