Clinical Trial Services for Medical Devices
● Regulatory Pathway Guidance: Assist each company’s medical device to determine the appropriate FDA approval pathway, whether it’s a Premarket Notification (510(k)), Premarket Approval (PMA), or De Novo classification for novel devices. Establish appropriate regulatory strategy and device classification in alignment with company’s perspectives
● Investigational Device Exemption (IDE): Prepare and submit an IDE application if the device requires clinical trials. Ensure compliance with FDA regulations for the clinical investigation of medical devices.
● If FDA requires additional studies, MedApex Research will assist with establishing exploratory and/or feasibility studies to evaluate the safety and performance of your medical device.
● FDA submissions for approval to move forward with large-scale trials, such as:
■ Larger studies designed to demonstrate the safety and efficacy of your device.
■ In-depth data collection and analysis for FDA Pre-Market Approval (PMA) or 510(k) submission.
● Assist with FDA’s Post-Market Surveillance:
■ Continued oversight of your device’s performance in the market to ensure safety.
■ FDA reporting and compliance support to maintain market approval.
MedApex Research CRO Activities and Clinical Trial Responsibilities:
● Medical Device Protocol Development and Feasibility: Develop a detailed clinical trial protocol that outlines study objectives, design, and device-specific safety measures. Ensure that the protocol meets FDA requirements and aligns with Good Clinical Practice (GCP) for medical devices.
● Feasibility Assessment: Conduct feasibility studies to assess the practicality of conducting the trial at selected sites, including site resources, expertise, and patient availability.
● Clinical Trial Site Selection and Initiation: Identify qualified investigators and clinical trial sites based on their experience with similar devices, available infrastructure, and track record.
● Site Initiation Visits: Conduct site initiation visits to train site personnel, review trial requirements, and ensure that the investigational device and protocol are fully understood.
● Device Accountability and Logistics: Manage the distribution and tracking of the investigational device, ensuring proper handling, storage, and accountability throughout the trial.
● Device Labeling: Ensure that investigational devices are appropriately labeled and meet FDA and international regulatory requirements.
● Trial Monitoring and Data Management: Conduct on-site and remote monitoring visits to ensure protocol adherence, accurate data collection, and patient safety. Address any deviations or issues identified during monitoring.
● Data Capture and Validation: Use electronic data capture (EDC) systems to ensure that data is collected efficiently and validated regularly to avoid errors.
● Safety Oversight and Compliance: Establish Data Monitoring Committees (DMCs) to review ongoing safety data, especially for high-risk devices. Adverse Event and Device Malfunction Reporting: Monitor and report any device-related adverse events or malfunctions in compliance with FDA regulations and ensure they are investigated and resolved appropriately.