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Individual Case Safety Reports (ICSR) Processing and Reporting

Clinical Pharmacovigilance Expertise and Resources

The capture and analysis of safety data is critical in clinical trial management as trials must thoroughly demonstrate safety and efficacy.

At ProPharma Group, our Clinical Pharmacovigilance (PV) Individual Case Safety Reports (ICSR) Specialists provide project management, subject matter expertise, and case processing services that are customized to meet clients’ needs.

Our internal healthcare professionals (nurses and PharmDs) complete all case processing and quality review activities with particular attention to timelines and submission requirements for global regulatory authorities. As a provider of both clinical and postmarketing PV services, we provide one global safety database and ensure a smooth transition from clinical to postmarketing safety services.

Reduce Time and Expense with Our High-Quality Processing

Our team of experts has extensive experience in providing these clinical pharmacovigilance services specializing in ICSR processing and analyzing safety data including case intake, data entry, coding, medical review, follow up, quality control, and reconciliation.

We support clients by providing ICSR processing in a fully compliant and validated safety database. Our system is secure and has appropriate backup, business continuity, and disaster recovery procedures in place. Our processes and systems are regularly audited and have a long history of compliance. In addition, we also have knowledge and experience with all major safety databases.

Expedited reporting is a fundamental activity in any pharmacovigilance system, and we understand compliance is business critical. Our PV experts monitor regulatory intelligence and stay informed of any changes in regulations and update core regulatory reporting procedures accordingly.

We also have specialized submissions teams who are qualified for electronic submissions to regulatory authorities and reporting to investigators, IRBs, and ECs.

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Need Help Managing Your Drug Safety Requirements?

Contact us to learn how our clinical and postmarketing PV services can support your needs on a standalone basis or integrated with global Medical Information and Regulatory services.

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