Clinical Services

Clinical evidence is critical to proving the safety and efficacy of medical devices. Our clinical services are designed to support manufacturers in planning, conducting, and reporting clinical trials that meet the regulatory standards of bodies like the FDA and EU MDR. We provide a range of services that help manufacturers gather the data needed to bring their devices to market and maintain compliance post-market.

Our services begin with clinical trial planning and strategy development. We work with manufacturers to develop clinical investigation plans (CIPs) that outline the study objectives, methodology, and regulatory requirements. Whether it’s a pre-market trial or a post-market study, our experts ensure that the trial design meets both regulatory and scientific standards. We assist with protocol development, patient recruitment, site management, and data collection, ensuring that every aspect of the study is managed efficiently.

One of the critical regulatory requirements for medical devices is compliance with Good Clinical Practice (GCP) standards, which govern the ethical and scientific quality of clinical trials. Our team ensures that all clinical investigations adhere to GCP guidelines, protecting patient safety while generating reliable clinical data. For devices that require an Investigational Device Exemption (IDE) from the FDA, we help manufacturers prepare and submit the necessary documentation.

In addition to pre-market trials, we support manufacturers with post-market clinical follow-up (PMCF) studies required under the EU MDR. These studies are critical for ensuring the ongoing safety and performance of medical devices once they are in use. We help manufacturers design and execute PMCF studies that gather real-world evidence, which is increasingly important for maintaining regulatory compliance in a post-market setting.

Our clinical services include:

• Post-market Clinical Follow-up (PMCF): Conduct post-market clinical follow-up studies to gather ongoing data on the safety and performance of your device in real-world use.
• Post-market Performance Follow-up (PMPF): Continuously monitor the performance of in vitro diagnostic (IVD) devices through PMPF studies to ensure ongoing compliance and effectiveness.
• Summary of Safety and Clinical Performance (SSCP): Prepare and submit comprehensive summaries of safety and clinical performance as required under EU MDR, ensuring transparency and compliance.
• Summary of Safety and Performance (SSP): Develop summaries of safety and performance to support regulatory submissions and demonstrate the benefit-risk ratio of your device.
• Clinical Risk Management: Integrate clinical risk management throughout the product lifecycle, ensuring that risks are properly identified, assessed, and mitigated.
• Clinical Strategy and Planning: Develop a tailored clinical strategy that aligns with both regulatory requirements and the specific needs of your device, covering pre- and post-market phases.
• Clinical Evaluation (Plan & Report): Conduct detailed clinical evaluations, including the creation of clinical evaluation plans and reports to support regulatory submissions and compliance.
• Clinical Investigation and PMCF Studies: Design and conduct clinical investigations and post-market clinical follow-up (PMCF) studies to gather essential clinical data.
• Performance Evaluation and Studies: Conduct performance evaluations for IVD devices, ensuring compliance with regulatory requirements and ongoing device improvement.
• Biological Evaluation (Plan & Report): Prepare biological evaluation plans and reports as part of a comprehensive risk management strategy, ensuring the safety of the device’s biological impact.
• Toxicological and Biological Risk Assessment: Assess the toxicological and biological risks of your device, ensuring compliance with regulatory safety standards.
• Benefit-Risk Assessment and Ratio: Evaluate and document the benefit-risk ratio of your device to demonstrate its clinical value and justify its continued market presence.

Our clinical services extend to data analysis and regulatory reporting, helping manufacturers submit comprehensive clinical trial reports (CTRs) to regulatory authorities. We assist with preparing the necessary documents for submissions, ensuring that the data is presented clearly and meets the requirements of bodies like the FDA, EMA, and other regulatory agencies. From trial initiation to final reporting, we provide end-to-end support to help you bring safe, effective devices to market.

Our flexible approach to clinical services means we can tailor our support to meet the unique needs of your trial, whether you require full-service clinical trial management or targeted support for specific trial phases. By providing expert guidance throughout the clinical process, we help manufacturers generate the evidence needed to meet regulatory requirements and demonstrate the safety and efficacy of their devices.

We have compiled a list of articles and training courses on the issue of clinical affairs to help you and your colleagues.

Why Rigorous Clinical Evaluations Matter: Strategies To Boost Safety and Compliance
Did you know that 40% of medical device submissions are delayed due to inadequate clinical evaluations? This white paper provides a blueprint for achieving excellence in clinical evaluations through strategic enhancements.

ISO 14971:2019 - Application of Risk Management to Medical Devices Overview
This two-hour self-paced risk management eLearning presents the key foundations of the risk management process defined in ISO 14971 and provides expert tips on how to navigate the process.