PV team of C&R Research provides client-tailored PV services from clinical phase to post-approval. With over 20 years’ experiences in clinical development, we integrated our professionalism of safety information management.
Pharmacovigilance System Establishment
- Pharmacovigilance Consulting
- Development and Maintenance of Pharmacovigilance-SOP
- Management and Maintenance of Safety Database
- Safety Database reconciliation
- Pharmacovigilance Training
- SMP (Safety Management Plan)
- RMP (Risk Management Plan)
- DSUR (Development Safety Update Report), PSUR (Periodic Safety Update Reports)
- PBRER (Periodic Benefit-Risk Evaluation Report)
Clinical & Post-Approved Safety Data Management
- Receipt and validation of SAE Report and ICSR
- SUSAR (Suspected Unexpected Serious Adverse Reaction) Handling
- Preparation of CIOMS I report
- ICSR (Individual Case Safety Report) Management
- MFDS, KIDS and Headquarter Reporting
- Medical Review
Overall PV service portfolio
PV team provides optimized solutions to meet the client demands throughout the product lifecycle. Development of PV- SOPs, management of safety information and PV writing service.
Retention of experiences and expertise
PV team provides a wide range of high-quality PV services in full compliance with local and global regulatory requirements. We have comprehensive knowledge in clinical trials with years of experiences and in-depth expertise on medicinal products and medical devices, as well as practical experiences in safety information management.
With 24-hour availability, PV team works closely with clients to facilitate the efficient communication.
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