Pharmacovigilance and Safety

Pharmacovigilance and Safety 2018-10-11T17:43:02+00:00

The DP Clinical pharmacovigilance and safety team offers SAE review and the creation of 21 CFR Part 11-compliant materials for submission to regulatory authorities and Data Safety Monitoring Boards (DSMBs). We can provide full safety support or work with your safety team to meet study needs.

DP Clinical provides the following pharmacovigilance and safety services:

  • Medical Monitoring
  • Coding of adverse events and medications (MedDRA and WHO Drug)
  • Review and management of suspected/reported Serious Adverse Events (SAEs)
  • Preparation of MedWatch and CIOMS forms
  • Preparation of safety narratives
  • Individual Case Safety Report (ICSR) processing for SAEs
  • Management of adjudication and Data Safety Monitoring Committees