Our experienced Drug Safety Physicians are MedDRA trained with clear understanding of SMQs and IMEs to support review of various pharmacovigilance data.
- Independent medical review of SAEs & SUSARs cases from clinical trials and ICSRs in post marketing
- Independent review of signal and benefit-risk management documentation including signal reports
- Design qualitative Signal detection methodologies for your products
- Independent literature review by the Drug Safety Physicians for literature review and compliance
- Development of Safety Management Plan (SMP).