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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.
 
To know more about Veeda services or if you have any query please click here to contact us
 
To know more how veeda’s expertise and experience for Pharmacovigilance can help you, please be in touch with us using this form
 
 
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