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About service

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
  • Pharmacovigilance Training

Pharmacovigilance Writing

  • SMP (Safety Management Plan)
  • RMP (Risk Management Plan)
  • DSUR (Development Safety Update Report), PSUR (Periodic Safety Update Reports)
  • PBRER (Periodic Benefit-Risk Evaluation Report)
  • Post Marketing Study Protocol & CSR generation

Clinical & Post-Approved Safety Data Management

  • Safety Database reconciliation
  • Receipt and validation of SAE Report and ICSR
  • SUSAR (Suspected Unexpected Serious Adverse Reaction) Handling
  • Preparation of CIOMS I / MedWatch report
  • 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.

Efficient communication

With 24-hour availability, PV team works closely with clients to facilitate the efficient communication.

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