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

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