We provide a comprehensive range of clinical performance services for In Vitro Diagnostic (IVD) products designed to ensure that your products generate the necessary data to support their safety, effectiveness, and marketability.
Our experienced team of professionals collaborates closely with you to develop, execute, and assess clinical studies and performance evaluation plans that meet various regulatory requirements.
Our clinical performance services for IVD products include:
- Clinical study design and protocol development: We assist you in designing appropriate clinical studies to meet the specific regulatory requirements and to demonstrate the clinical performance, safety, and effectiveness of your IVD products.
- Clinical site selection and management: We help you identify and manage suitable clinical sites, ensuring accurate and efficient data collection by coordinating with clinical investigators and laboratory personnel.
- Study monitoring and quality assurance: Our team monitors the progress of your clinical studies, ensuring compliance with study protocols, Good Clinical Practice (GCP), and regulatory requirements, while also minimizing risks and maintaining data integrity.
- Performance evaluation report preparation: We support you in the preparation of performance evaluation reports, which are essential for regulatory and demonstrating the clinical performance of your IVD products.
- Clinical data management and analysis: We assist you with the collection, management, and analysis of clinical data generated during the studies, extracting meaningful insights and drawing robust conclusions to support your product claims.
- Regulatory support for clinical studies: We provide guidance on the regulatory requirements related to clinical studies for IVD products, helping you navigate complex regulations, such as the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR) and United States FDA requirements.
- Post-market clinical follow-up: We help you design and implement post-market clinical follow-up plans to monitor the ongoing clinical performance and safety of your IVD products after they have been introduced to the market.
Through our clinical performance services, we strive to ensure that your IVD products meet the highest quality and safety standards while generating the essential clinical evidence needed for regulatory approval and market success. Please feel free to contact us for more information or to discuss the specific needs of your IVD product development project. We look forward to partnering with you and supporting your success in the IVD industry.
