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
- ADR case processing with medical review
- Drug safety literature review
- Provision and support with EU-QPPV services
- Signal detection- benefit-risk evaluation
- Reporting & submissions for drugs, vaccines, medical device, cosmetics & nutritionals
- Production and submission of reports inlcuding PBRERs, PADERs, SBRs, ASRs & DSURs
- Risk management plans/ REMS
- Medical writing services
- Clinical trial drug safety protocol support
- Safety database build & validation
- Expertise handling country-specific PV requirements for Expanded Access Programs
NEED MORE INFORMATION?
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