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| 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. |
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| We offer: |
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- 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
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| Our medical/pharmacovigilance coverage is available 24 hours per day, 7 days per week. |
