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
December 19, 2024
WHO Issues Guidance on Antibiotic Pollution Control
WHO issues guidance to control antibiotic pollution from manufacturing, addressing environmental and global health impacts of antimicrobial resistance.
December 18, 2024
Nonclinical Drug Development: FDA Recommendations for Confirming an Ames Positive Finding
Explore FDA's recommendations on follow-up testing for Ames-positive drugs to support first-in-human clinical trials. Learn how to navigate FDA regulations and ensuring successful product development.
December 17, 2024
Navigating Market Access & Reimbursement Strategy for Medical Devices in Europe
Explore the importance of market access and reimbursement strategies for medical devices and in vitro diagnostics (IVDs) in Europe. Learn how early planning and the new European HTAR can enhance the...
News & Insights
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.
October 9, 2024
ProPharma Receives 2024 CPHI Regulatory and Compliance Award
ProPharma wins CPHI Pharma Award for excellence in regulatory and compliance innovation, enhancing efficiency and accelerating market access for life-saving therapies.
September 30, 2024
ProPharma Names Dawn Sherman Chief Executive Officer
Dawn Sherman rejoins ProPharma as CEO, bringing nearly 30 years of industry experience to lead the regulatory, clinical, and compliance services provider.
