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CLINICAL AFFAIRS


Kymanox understands that clinical decision making is a contextual, continuous, and evolving process in which data are gathered, interpreted, and evaluated to develop an evidence-based choice of action. We approach clinical evaluation of complex combination products with a multi-disciplinary, risk-based approach while engaging our board-certified Medical Doctors, PhD-, and MPH-level Subject Matter Experts (SMEs) in regulatory affairs, safety, statistics, and engineering (e.g., biomedical, chemical).


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Clinical Compliance Solutions


With all projects, we utilize expert project management to track scope, schedule, budget, and risk.

Kymanox provides clinical compliance services in the following areas:

    • Clinical Evaluation Reports (CERs) and Relevant SOPs

    • Preparation and Planning for Performance Evaluation Reports (PERs)

    • Risk-Benefit Analysis, Gap Assessments, and Risk Management

    • Clinical Data Analysis and Comprehensive Literature Search

    • Pharmacovigilance for Drug, Device, and Combination Products

    • Clinical Quality Management System Development and Optimization

    • Investigator Site Audits and Quality Agreements

      Sample Guidance Expertise


      Kymanox has interacted directly with Notified Bodies (e.g., BSI, SGS, TUV) and indirectly for assistance with remediation and audit preparation. We understand the implications of the new EU and US regulations and guidances, including the following:

      • Regulation (EU) 2017/745 and 2017/746 of the European Parliament and of the Council

      • Benefit-Risk Factors to Consider When Determining Substantial Equivalence in Premarket Notifications (510(k)) with Different Technological Characteristics (2018)

      • Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drugs and Biologics (2019)

      • Post-Marketing Safety Reporting for Combination Products (2018)

        Synergy with other Kymanox Services


        Kymanox holds a 360° view of Quality + Compliance. We augment our Clinical Affairs activities with the following capabilities:

        • Regulatory Affairs

        • Pharmacovigilance

        • Quality Engineering

        • Quality Auditing

        • Project Management Office

          Integrating our services ensures that the appropriate SMEs are utilized and that the clinical solutions provided (e.g., clinical risk-benefit assessment, CER, gap analysis) are done Right First Time.

          Biotechnology | Pharmaceuticals | Medical Devices | Combination Products