Drug Safety and Pharmacovigilance

Drug Safety and Pharmacovigilance

Pharmacovigilance: Risk Mitigation for Your Compound

Mitigating risk is a critical component to a compound’s success during the development process and into commercialization. To meet the increasingly complex and diverse global regulatory requirements, we offer a comprehensive suite of pre- and post-authorization services designed to ensure safety while focusing on the rapid approval of your compound and pharmacovigilance monitoring thereafter.

Our quality driven processes are monitored by licensed healthcare professionals (e.g. registered nurses, physicians and pharmacists) who are trained to effectively assess, analyze and evaluate the emerging safety profile of your compound with an exceptional level of quality and compliance.

  • Customized Safety Surveillance
  • Safety Narrative Writing
  • Safety Signal Management
  • Aggregate Report Management
  • Adverse Event & Product Complaint Management
  • Individual Case Reporting
  • Call Center Function
  • Safety Database Services
  • Literature Monitoring and Media Monitoring Search
  • Clinical Adjudication Committee Management
  • Development of Adjudication Materials
  • Eudravigilance Reporting

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

Postmarketing Safety Services Include the Following:

  • Adverse Event (AE) and Product Complaint (PC) management
  • Individual case reporting and global call center function
  • Safety database services
  • Global literature and media monitoring process that includes search strategy and review
  • Safety signal detection and aggregate report management
  • Region-specific pharmacovigilance management such as:
    • Maintenance of a certified pharmacovigilance system (i.e. PSMF) for pharmaceutical companies in the EU
    • European Union-qualified person for pharmacovigilance (QPPV)
    • Risk management plan development and maintenance
    • In-country pharmacovigilance services (including local literature surveillance and national contact persons)
    • EudraVigilance profile management