Global Individual Case Safety Reports (ICSR)

ICSR Reporting

Ensuring patient safety is the most important component of a pharmacovigilance (PV) system. Therefore, all pharmaceutical and biotechnology companies are required to identify, collect, and process Individual Case Safety Reports (ICSRs) in a systematic and robust manner, and report to regulatory authorities in accordance with strict requirements and timelines.

ProPharma recognizes the critical nature of accurate and on-time submissions to regulatory authorities, Institutional Review Boards (IRBs), Ethics Committees (ECs), and investigator sites.

We perform ICSR submissions including MedWatch, CIOMS I, E2B(R2), and E2B(R3) reports for various product types including approved and non-approved drugs, biologics, devices, vaccines, dietary supplements, cosmetics, homeopathic products, and natural health products.

ProPharma's ICSR Workflow

ICSRs are exchanged with clients and Sponsors for review and comment before the final submission, if requested. Clients and Sponsors also maintain oversight of case processing and reporting activities ahead of submission via Case Explorer, a read-only application that allows for real-time database queries and review of information within individual cases.

Clients and Sponsors who wish to maintain oversight of case processing within the safety database itself may also do so via read-only access as part of individual user implementation and security procedures.