Individual Case Safety Report (ICSR)
At Masuu, we provide comprehensive Individual Case Safety Report (ICSR) case processing services that ensure the thorough, accurate, and compliant handling of adverse event reports. Our services are designed to support pharmaceutical companies, regulatory bodies, and healthcare organizations in meeting stringent global pharmacovigilance standards while ensuring patient safety and product efficacy.
Our ICSR Case Processing Approach- Robust Pharmacovigilance Safety Database:
Masuu utilizes a validated, compliant Pharmacovigilance safety database solution to collect, store, and process individual case safety reports. This system supports efficient case processing, regulatory submissions, and advanced analytics, ensuring scalable, secure, and compliant pharmacovigilance operations that meet both client and regulatory needs.
- Comprehensive Data Collection:
We gather case source data from a variety of channels to ensure accurate and complete data capture. Whether it’s from healthcare professionals, patients, clinical trials, or scientific literature, Masuu ensures that no critical information is overlooked, providing a clear, comprehensive picture of every adverse event..
- Thorough Case Triaging and Validation:
Once we receive the case data, our expert team conducts triaging and validation to determine the seriousness, completeness, and relevance of each report. We prioritize cases based on regulatory requirements and client-specific needs, ensuring that critical cases are processed in a timely manner to meet compliance deadlines.
- MedDRA Coding for Standardization:
To ensure consistency in reporting and international compliance, we apply MedDRA coding to all medical terms. This standardized coding system supports accurate classification of adverse events, reducing discrepancies and aligning with global pharmacovigilance standards.
- Precise Data Entry and Narrative Preparation:
We ensure accurate data entry into the database, including detailed narrative preparation for each case. Our team crafts clear, concise, and comprehensive narratives that describe adverse events, providing regulatory bodies with all necessary information for evaluation.
- Expert Medical Review and Analysis:
Our team of medical experts conducts a thorough review of each case, evaluating its medical significance, causality, and clinical implications. We ensure that all relevant details are considered, providing a detailed and expert analysis that supports informed regulatory decisions.
- Rigorous Quality Checks:
Masuu’s quality assurance process includes a multi-step review procedure that ensures the accuracy, completeness, and compliance of each ICSR before submission to regulatory authorities. Our commitment to continuous improvement means that feedback from quality reviews is constantly integrated to refine and enhance our processes.
- Timely Follow-Up and Client Coordination:
We work closely with our clients to ensure prompt follow-up on cases, gathering any additional information necessary for a comprehensive report. Our team provides regular updates to clients, ensuring clear communication and alignment throughout the case processing journey.
- Transparent Project Management and Reporting:
Masuu excels in project management, ensuring efficient ICSR case processing within predefined timelines. We deliver regular progress reports, providing our clients with detailed updates on case statuses and highlighting any critical findings, so they remain fully informed and compliant with regulatory standards.