Masuu Global’s ICSR Case Processing Services ensure thorough, accurate, and compliant handling of individual case safety reports, supporting clients in meeting regulatory requirements and maintaining high standards of pharmacovigilance.

Pharmacovigilance Safety Database:
  • Safety Database Software:
    Masuu is using a validated and compliant Pharmacovigilance safety database solution.
  • Efficient Case Processing:
    The system supports efficient case processing, regulatory submissions, and advanced analytics, ensuring secure and scalable PV operations.
Receiving the Cases Source Data:
  • Data Collection:
    We collect and receive case source data from various channels, ensuring accurate and comprehensive data capture.
Triaging/Validation of the Cases:
  • Case Assessment:
    Our team conducts thorough triaging and validation of cases to determine their seriousness, completeness, and relevance.
  • Prioritization:
    We prioritize cases based on regulatory requirements and client specifications, ensuring timely processing.
MedDRA Coding:
  • Standardized Coding:
    We use MedDRA (Medical Dictionary for Regulatory Activities) for accurate and standardized coding of medical terms.
  • Consistency:
    Our coding process ensures consistency and compliance with international regulatory standards.
Data Entry to the Database Including Narrative Preparation:
  • Accurate Data Entry:
    We enter case data into the database with precision, including detailed narrative preparation to describe the case clearly and concisely.
  • Database Management:
    Our team ensures the database is up-to-date and compliant with regulatory requirements.
Medical Review
  • Expert Analysis:
    Our medical experts review the cases to assess the medical significance, causality, and clinical implications.
  • Detailed Evaluation:
    We ensure thorough evaluation and interpretation of clinical data to support regulatory submissions.
Quality Review
  • Rigorous Quality Checks:
    We conduct rigorous quality reviews to ensure accuracy, completeness, and compliance with regulatory standards before submission to regulatory authorities.
  • Continuous Improvement:
    Feedback from quality reviews is used to continuously improve our processes and documentation.
Follow-Up of the Cases (in Coordination with Client)
  • Client Coordination:
    We coordinate with clients to follow up on cases, gather additional information, and ensure all necessary data is collected.
  • Timely Updates:
    Regular updates and communication with clients to keep them informed of case status and progress.
Project Preparation of ICSR Management and Update to Client
  • Project Management:
    We prepare and manage ICSR projects, ensuring all cases are processed efficiently and within timelines.
  • Client Reporting:
    Regular updates and reports are provided to clients, detailing the status of ICSR management and any significant findings.
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