Pharmacovigilance & Medical Safety
Accurate and comprehensive pharmacovigilance systems and pharmacoepidemiology activities throughout the entire product life cycle are essential to protect patients and public health.
Symyoo’s pharmacovigilance and pharmacoepidemiology (PV&PE) team has spent multiple years working in the pharmaceutical company and has first-hand knowledge of regulatory requirements and therapeutic experience. Symyoo’s PV & PE team offers high-quality services to support thorough examination and quality control of all safety reports as well as comprehensive assessment of risk-benefit of drug use and is dedicated to ensure that projects comply with changing regulatory environments.
Prevention, Detection and Assessment of Adverse Effects
Symyoo serves to organize and coordinate Data Monitoring Committee (DMC) or Data and Safety Monitoring Board (DSMB) with qualified members, including physicians, biostatisticians, clinical operations representatives, data manager, and/or safety surveillance experts.
The DMC or DSMB adds to the objectivity and credibility of clinical trials and serves the independent certification on issues such as adjudication of efficacy endpoints, conduct of planned interim analyses, and safety monitoring.
- Clinical Safety Risk-Benefit Analysis and Monitoring Plan
- Regulatory and IRB Affairs for Pharmacoepidemiology Studies
- Management and Reporting of (Serious) Adverse Events
- Periodic/Final Safety Report Writing
- Post-Marketing Surveillance (PMS)
MEDICAL SAFETY AND
- Medical Safety Management
- Independent DMC/DSMB Charter Service and Committee Composition
- DMC/DSMB Meeting Coordination