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.