- Pharmacovigilance
- Adverse Event Reporting Across Clinical Trials and Post-Market
- Comprehensive ICSR Management for Global Compliance
- Proactive Signal Detection and Risk Management in Drug Safety
- Pharmacovigilance Gap Analysis: Strengthening Your Compliance Framework
- Post-Market Surveillance: Ensuring Ongoing Drug Safety
- Literature Surveillance for Pharmacovigilance: Tracking Emerging Risks
- Preparing for Pharmacovigilance Audits: Best Practices for Compliance
- Internal Pharmacovigilance Audits: Ensuring Regulatory Readiness
- The Role of the QPPV in Ensuring Global Pharmacovigilance Compliance
- Meeting European Pharmacovigilance Standards with QPPV Oversight
- Observational Studies and Real-World Evidence in Drug Safety
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What is ICSR Management and Why is it Important?
Individual Case Safety Reports (ICSRs) are detailed records of adverse events reported by healthcare professionals, patients, or manufacturers. ICSRs are submitted to regulatory authorities as part of the pharmacovigilance process to document any drug-related safety concerns.
At Viltis, we provide end-to-end ICSR management services that include case intake, processing, and regulatory submission, ensuring that each report is handled with precision and in compliance with global standards.
Key Components of ICSR Management
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Case Intake: We manage the intake of ICSR data from multiple sources, including clinical trial sites, healthcare providers, and spontaneous reports from patients. Ensuring that all necessary data points are captured and validated is critical to ensure that cases are processed correctly.
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Case Processing: Our team of experts thoroughly reviews each ICSR, assessing the case’s severity, causality, and the need for regulatory reporting. We ensure that all regulatory requirements are met, from data accuracy to submission timelines.
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Regulatory Submissions: ICSRs must be submitted in compliance with country-specific guidelines, including e-submissions to databases such as the FDA’s FAERS and EMA’s EudraVigilance system. Viltis’ experienced team ensures that all reports are properly formatted and submitted within the appropriate timeframes.
How ICSR Management Ensures Global Compliance
Failure to properly manage ICSRs can result in non-compliance, leading to severe regulatory action. By outsourcing ICSR management to Viltis, you ensure that your pharmacovigilance activities are compliant with evolving global regulations.
Our Comprehensive ICSR Management Services Include:
- Global ICSR Submission: Timely submission of ICSRs to multiple regulatory bodies based on country-specific guidelines.
- Compliance Monitoring: Regular reviews of evolving regulatory requirements to ensure that all ICSR processes stay compliant with international standards.
- Automation and Efficiency: Using state-of-the-art pharmacovigilance software, we streamline the entire ICSR process, reducing manual errors and speeding up the time to submission.
Partner with Viltis to streamline your ICSR management, improve efficiency, and ensure global compliance. By outsourcing these critical functions, you gain the peace of mind that your product’s safety profile is being managed expertly and in alignment with global standards.