Clinical Services > Drug Safety

Drug Safety

 

Our strategic relationship with Drug Safety Management partners that enable us to provide the highest quality deliverables across a wide array of clinical services.

Through our preferred partners, we offer drug safety services including Serious Adverse Event (SAE) collection and reporting, subject safety narrative preparation, safety database, safety database reconciliation, and safety data review. In addition, we provide Investigator and Ethics Committee safety notifications, as well as annual reporting services such as IND, EU ASR, and DSURs.

 

Key advantages to partnering with PRC Clinical for Drug Safety include:

  • Experienced Drug Safety staff
  • Development of Safety Monitoring Plan
  • SAE notifications to sites and sponsor within 24 hours
  • Development of Safety Narrative Template
  • Full SOPs (Standard Operating Procedures)

 

Drug Safety Management Services for your clinical trials include:

  • Serious Adverse Event (SAE) collection and reporting
  • Subject Narratives
  • Safety Database
  • Database Reconciliation
  • Safety Data Review
  • Investigator and Ethic Committee safety notifications
  • Annual reporting (IND, EU ASR, and DSURs)