Patient safety is a critical component to clinical trials. Monitoring the safety signals throughout the whole drug development process and real life use is a key process to ensure patient safety.
FMD K&L’s safety system is based on the industry leading Argus system. We can also establish B2B connection to our sponsor’s safety system and perform the services using our sponsor’s system. We have a pool of highly experienced physicians and case processors that can thoroughly process the safety events, perform seriousness / causality / expectedness assessments, and explore safety trends and signals.
Our safety process has successfully passed the audit from many major pharmaceutical and device companies. The key safety processes include:
- Case Entry and Quality Control
- Narrative Writing
- Medical Review
- SAE Reconciliation
- World-wide Case Submission