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Pharmacovigilance 2018-03-28T14:56:01+00:00

Pharmacovigilance

Through our in-house capabilities and partnerships with a select group of external companies, WEP Clinical can provide bespoke pharmacovigilance (PV) services for your programs. Whether you require a reactive, “light touch” approach with simple event reporting or a more proactive, “full service” approach with broader event collection and processing activities, 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 doctor 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

If you would like more detailed information about our pharmacovigilance services please contact us at:

Pharmacovigilance
Pharmacovigliance