DP Clinical offers comprehensive pharmacovigilance services for Phase I- III clinical trials (investigational products and medical devices). Our services are fully compliant with US FDA regulatory standards (21 CFR Part 11) and our validated safety database meets ICH E2B Guidelines for Clinical Safety Data Management. Our experienced Pharmacovigilance team and Medical Monitors are committed to providing quality driven pharmacovigilance support to meet the needs of your clinical study.
DP Clinical’s pharmacovigilance services include:
- Medical Monitoring by a Safety Physician
- Medical coding and coding review of adverse events and medications (MedDRA and WHO Drug)
- Establishment of Data Safety Monitoring Board (DSMB), including charter development, meeting coordination, and safety monitoring reporting
- Set up and maintenance of the Safety Database including reconciliation with clinical database
- Development of Safety Management Plan and Serious Adverse Event Reporting forms per protocol
- Preparation of Individual Case Safety Report (ICSR) processing of SAEs
- Preparation of medical narratives including SUSAR narratives
- Preparation of IND Safety Report (MedWatch, CIOMS) and submission
- Preparation of Development Safety Update Report (DSUR) and Annual Reports
