Pharmacovigilance
Through our in-house capabilities and partnerships with a select group of external companies, WEP Clinical 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.
BASIC ADVERSE EVENT REPORTING
Collect drug safety reports and perform an initial assessment of severity and urgency
- Follow up with physicians and provide additional support
- Cascade completed reports to sponsors/manufacturers
FULL SERVICE:
ADR case processing with medical review
Reporting & submissions for drugs, vaccines, medical device, cosmetics & nutritionals
Production, generation & submission of regulatory & aggregate reports (PBRERs, PADERs, SBRs, ASRs & DSURs)
Drug safety literature review
Provision and support with EU-QPPV services
Signal detection- benefit-risk evaluation
Risk management plans/ REMS
Medical writing services
Clinical trial drug safety protocol support
Safety database build & validation
Through our in-house capabilities and partnerships with a select group of external companies, WEP Clinical 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.
BASIC ADVERSE EVENT REPORTING
Collect drug safety reports and perform an initial assessment of severity and urgency
- Follow up with physicians and provide additional support
- Cascade completed reports to sponsors/manufacturers
FULL SERVICE:
ADR case processing with medical review
Reporting & submissions for drugs, vaccines, medical device, cosmetics & nutritionals
Production, generation & submission of regulatory & aggregate reports (PBRERs, PADERs, SBRs, ASRs & DSURs)
Drug safety literature review
Provision and support with EU-QPPV services
Signal detection- benefit-risk evaluation
Risk management plans/ REMS
Medical writing services
Clinical trial drug safety protocol support
Safety database build & validation