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
July 14, 2025
Dealing with API and Excipients in a Time of Tariffs
Navigating the complexities of API and excipient tariffs is crucial for pharmaceutical companies. Learn strategies to manage costs, source materials, and maintain compliance amidst changing US tariff...
July 11, 2025
FDA's "Radical Transparency" Shift: What Regulatory Pros Need to Know
FDA is publishing Complete Response Letters (CRLs) to increase transparency. Learn what this means for drug sponsors, regulatory consultants, and the future of FDA submissions.
July 10, 2025
Medical Information Contact Center: The Silent Revolution
AI revolutionizes Medical Information Contact Centers, enhancing speed, precision, and compliance while maintaining human insight and safety standards.
News & Insights
July 8, 2025
ProPharma Appoints Marshall Florence, Former FDA Labeling Expert, as Vice President, Labeling & Strategy to Advance Strategic Labeling & Promotional Review
ProPharma appoints former FDA labeling expert as VP, Labeling & Strategy, enhancing strategic labeling, promotional review, and regulatory consulting expertise to accelerate drug development and...
January 31, 2025
ProPharma Recognized for AI Excellence at ECCCSA
ProPharma wins Silver at ECCCSA for AI innovation in Medical Information, enhancing efficiency and quality in delivering accurate medical information.
October 21, 2024
ProPharma Appoints Brian Tuttle as Chief Financial Officer
ProPharma appoints Brian Tuttle as CFO to drive financial strategy and accelerate global growth, leveraging his 20 years of life sciences industry experience.
