Drug Safety and Pharmacovigilance

Drug Safety and Pharmacovigilance

Drug Safety and Pharmacovigilance Services

Our Clinical Safety, Clinical Endpoint Adjudication, and Postmarketing Safety teams offer global capabilities with offices and personnel in the United States and the European Union (EU).

Clinical Safety Services Include the Following:

  • Collection, evaluation, analysis, and reporting of safety information, including serious adverse events, unanticipated adverse device effects, and other significant safety events
  • Safety narrative writing including physician review
  • Coding (MedDRA, WHO Drug) of adverse event information
  • Assessment and evaluation of reportability and submission of reportable events to global regulatory authorities
  • EudraVigilance reporting and e-reporting in the EU
  • Experienced certified users of EudraVigilance
  • Provide expertise on safety-specific national regulatory requirements in many countries worldwide
  • Preparation and submission of annual safety reports, six monthly line listings, and periodic reports to global regulatory authorities
  • Custom safety surveillance including adverse event and laboratory data review and trend analysis

Clinical Endpoint Adjudication Services Include the Following:

  • Development of CAC Charters, site training tools, and other adjudication materials
  • CAC management, including selection, contracting, training and facilitation of meetings as well as collaboration with Academic Research Organizations
  • Streamlined communications; one point of contact for endpoint events and SAEs for Sponsors, Investigative sites, and CAC members
  • Event package compilation in tandem with SAE processing, including translation coordination and clinical/medical quality control reviews
  • Preparation of standard and customized adjudication status reports