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Individual Case Safety Reports (ICSR) Processing and Reporting

Clinical Pharmacovigilance Expertise and Resources

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The retention and correct analysis of safety data is essential in clinical trial management, as trials must meticulously validate safety and efficacy.

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‘ICSR’ refers to an Individual Case Safety Reports which must be compiled for each instance of a suspected or confirmed adverse event and submission of such report to the Competent Authority (CA) of the Member State.

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The ICSR makeup is precise and thorough, it includes:

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  • References for supervision and identification purposes, including where the report came from and who received it

  • All information from principal source(s)

  • Characteristics of the patient concerned

  • Explanation of the relevant events

  • Results of clinical tests and procedures

  • Characteristics of the medicinal product in question

  • Narrative style summary (description) of the case

  • Any further applicable accompanying information

At Gemini 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.

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It is expected that each ICSR should be:
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  • Validated before reporting

  • Submitted within exceptionally stringent and speedy timetables – starting from the time when minimal information is brought to your attention as the MAH – this includes your sales reps, contractors and any other individuals who are involved with the medicinal product

  • Quickly re-submitted as new or updated information becomes available, which has an impact on the original submission. However, it is critical that this new or updated information is accurate and precise.

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You also need to be sure that detailed Safety Data Exchange Agreements (SDEAs) exist regarding relevant information exchanges (including information from Literature Review) with any of your contractors. SDEAs must be prepared to ensure compliance with the provisional and final arrangements.

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Our internal healthcare professionals (nurses, PharmDs, MDs) complete all case processing and quality review activities with meticulous attentiveness to timelines.  We ensure that the submission requirements for global regulatory authorities are fulfilled with tremendous precision. 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.

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Why Choose Gemini Group for your ICSR COMPLIANCE?
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Advice from our expert drug safety services consultants ensures that:

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  • You stay well-informed of all the changes

  • Your submissions remain impeccably compliant throughout the transition from provisional to closing arrangements

  • You avoid burdensome and costly penalties accrued through non-compliance

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We support clients by providing ICSR processing in a fully compliant and validated safety database. Gemini Group uses Argus Oracle Health Sciences leading safety database. With years dedicated to providing pharmacovigilance services, our consultants are exerts in processing Individual Case Safety Reports (ICSR) and drug safety data. Our system server is secure, with state of the art backup and disaster recovery programs in place. In addition, we also have knowledge and experience with all major safety databases.

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Reduce Time and Expense with Our High-Quality Processing

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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.

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

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We understand the need to respect the deadlines, making the right decisions about expedited reporting, and keeping the appropriate people in your company informed. If necessary, we can tailor our established standard practices to your specific requirements. The whole system is subject to internal audit and open to your scrutiny. We also have specialized submissions teams who are qualified for electronic submissions to regulatory authorities and reporting to investigators, IRBs, and ECs.

 

However, entering data into a safety database is only a small portion of the requirements for proper pharmacovigilance supervision. Regular management reports, routine signal detection, database searches for signal evaluation (literature review), periodic safety update reports, and/or responses to regulatory authority inquiries all garner the same thoughtfulness to the quality and application of medical expertise.

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