Patient Safety in Clinical Trials

PPD’s clinical development group gives clients access to a dedicated pharmacovigilance team, customized to specific project needs to help you respond to increasingly complex regulatory standards.

Our experienced staff works to evolve your safety monitoring and safety reporting practices as regulatory needs change, allowing you to evaluate and manage risk over the lifetime of your product. With a highly-skilled team of medical and safety professionals with both regulatory and safety experience, we provide safety coverage 24 hours a day, seven days a week.

PPD’s robust five-tier quality program ensures the highest levels of safety services for your drug safety and development programs. At the same time, we give you access to innovative technology and technical capabilities spanning the full range of clinical trial pharmacovigilance practices.

Full Product Lifecycle Approach

PPD offers a comprehensive and flexible suite of pharmacovigilance services throughout the lifecycle of a clinical trial:

  • Program development
  • Individual case safety report processing for serious adverse events
  • Medical management review for both clinical and safety components of product development
  • Global regulatory requirement compliance and consulting
  • Adjudication services management and case processing
  • Coordination of data safety monitoring committees
  • Aggregate reporting (e.g., development safety update reports)
  • Medical device monitoring
  • Unblinding services
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