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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. |
