Data-Gap Analysis

Data-Gap-Analysis-Toxicological-Assessment

  • Identify key toxicity studies required for regulatory compliance and safety assessment

  • Evaluate the existing data and identify any gaps or missing studies

  • Determine the need for additional studies to fill the data gaps or ensure regulatory compliance

  • Conduct literature reviews to identify any existing data or studies to address the data gaps

    • Assess the quality and relevance of available data to meet regulatory requirements

  • Provide recommendations for filling the data gaps, including study design and implementation

    • Develop a comprehensive plan for conducting the necessary studies

    • Collaborate with CROs or analytical labs to execute the studies

    • Assist in the coordination and management of the data collection process

  • Analyze the collected data and provide a comprehensive report on the findings

  • Ensure compliance with regulatory guidelines and requirements

  • Offer ongoing support and guidance throughout the data gap analysis process