Pharmacovigilance activities
We offer high responsive, customised pharmacovigilance services which are industry-standard compliant,
ranging from small studies to complex, large multinational clinical studies and registries.
Our pharmacovigilance services can be deployed individually or as a package.
SOCAR offers the following pharmacovigilance services:
- Design, development and implementation of the (serious) adverse event database
- Data entry of (Serious) Adverse Events reports for trials using paper CRFs
- Query resolution and management
- Quality Assurance and Quality Control
- Patient narrative development
- Evaluation of medical integrity and completeness of the reported event
- Coding and validation of coding using MedDRA
- Periodic safety update reports
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