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Pharmacovigilance

 
Veeda Oncology can provide global pharmacovigilance/surveillance to assist in the development of new oncology therapies. Our safety team is experienced in pharmacovigilance activities in global studies.
 
We offer:
 
  • Design of Serious Adverse Event (SAE) forms for collection of data

  • Development of pharmacovigilance plans and input in the safety section of protocols

  • Processing of SAEs including medical review to determine reportability

  • Preparation and distribution of safety reports (MedWatch, CIOMS) including submission to regulatory authorities, if required

  • Preparation/writing of SAE narratives

  • Ongoing review of safety data

  • Periodic Safety Update Reports (PSURS) and annual reports

  • AE-SAE reconciliation of safety and clinical databases

  • Monitoring for trends in safety
Our medical/pharmacovigilance coverage is available 24 hours per day, 7 days per week.
 
 
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