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.
ICSR Compliance
Monthly Compliance Metrics
Each month, compliance metrics are generated from submission records in the safety database for all pharmacovigilance and clinical safety programs and shared with all...
+99% Compliance Submission Rate
ProPharma is proud to post a greater than 99% compliance rate, successfully submitting over 2,000 ICSRs per month to regulatory authorities and business partners on...
What is an Individual Case Safety Report (ICSR)?
An Individual Case Safety Report (ICSR) is a document that captures information needed to report one or more suspected adverse reactions to a medical product that occur in a single patient at a specific point in time. ICSRs are used to support the monitoring and evaluation of the safety and effectiveness of medical products, such as drugs, biologics, vaccines, devices, and tobacco products. ICSRs are also used to identify potential signals of new or emerging safety issues, or changes in the known safety profile of a product.
News & Insights
February 2, 2026
AI in PV Surveillance: Aligning Innovation with Regulatory Expectations
Explore how AI is transforming pharmacovigilance while ensuring patient safety, data integrity, and regulatory compliance with insights from the 2025 CIOMS report.
January 29, 2026
Preparing for eCTD 4.0: What FDA Submitters Need to Know
eCTD 4.0 is coming. Learn what’s changing, why early planning matters, and how FDA submitters can prepare for a smooth transition.
January 26, 2026
Elevating Laboratory Compliance in 2026: How Pharma & Biotech Navigate GLP, Outs...
Discover how pharmaceutical and biotech companies can elevate laboratory compliance in 2026 through GLP, strategic outsourcing, and robust quality assurance.
News & Insights
January 27, 2026
ProPharma Sets the Gold Standard in Sustainability with SBTi-Approved Net-Zero T...
ProPharma’s greenhouse gas reduction targets are validated by SBTi, aligning with the Net-Zero Standard and a commitment to reach net-zero by 2050.
December 11, 2025
ProPharma Expands Operations with New Office in Hyderabad
ProPharma expands with a new office in Hyderabad, enhancing innovation and growth in regulatory, clinical, and compliance services for the life sciences industry.
December 4, 2025
ProPharma Welcomes Dan Ryan as President of Clinical Research Solutions
ProPharma taps Daniel Ryan as President of Clinical Research Solutions, strengthening its clinical trial management leadership and expanding its FSP Solutions.
