Medical Affairs

Adverse Events/Product Quality Complaints

Regulatory Expertise


Our Medical Information Specialists are highly trained on the regulatory aspects of communicating with patients, caregivers, and health care professionals, including the handling of AEs, Medical Device Reports, and PQCs.

  • AEs and PQCs are recognized through careful listening and a full knowledge of our clients’ products.
  • Reportable events are thoroughly documented in the program’s Diligent-based or client-based CRM.
  • Case reports auto-generated from Diligent-based CRM are sent to our clients’ Drug Safety staff and/or Pharmacovigilance partner.
  • Automated reconciliation processes between Diligent and Drug Safety/PV “tick and tie” all case reports.
  • Follow-up contacts made as requested to gather additional information.

Additional Medical Affairs Services