Clinical investigations to determine the safety and performance of medical devices and diagnostics pre- and post-market are of increasing importance. The design of these studies can range in complexity considering the classification of the device (Class II and III) and might require a range of approaches, from controlled, randomized and blinded clinical evaluations in a pre-market setting to non-interventional, real-world evidence and even retrospective designs as part of post-market clinical evaluation. Medical devices and diagnostics are often subject to continuous innovation and iterative development, and the Clinical Evaluation Report (CER) has become an essential regulatory requirement to document ongoing safety and performance throughout the lifecycle of medical device products. Understanding the goals of each clinical investigation is paramount in driving feasibility assessments to ensure the optimal country and site scenario.
Medical Devices & Diagnostics
Feasibility Plus™
Through Feasibility Plus™, ClinChoice identifies the optimal countries and research sites to deliver medical device projects or programs most effectively. Feasibility Plus™ positions ClinChoice as a valued partner, often enlisted to rescue medical device and diagnostic clinical investigations delayed by poor recruitment.
The FeRMI System
FeRMI is ClinChoice’s revolutionary feasibility solution, which pioneered the use of a 100% e-solution with real-time data analysis. FeRMI boasts a robust data analysis and reporting module that enables simultaneous trend monitoring and shapes feasibility as data is collected. By collecting data electronically, information becomes instantly accessible on any device with a secure web connection. Through FeRMI, ClinChoice can rapidly collect and analyze feasibility datasets, including responses from hundreds of sites around the globe.
Our Site Selection Approach
Site selection is a critical element of successful medical device and diagnostic development projects and programs. We base site selection criteria on four guiding principles proven to ensure complete enrollment according to predetermined timelines:
- Predictability: The site should demonstrate a consistent track record of accurately forecasting patient enrollment, showcasing reliability in estimating the required numbers.
- Enrollment: The site should exhibit a proven history of successfully enrolling the specified number of patients, demonstrating an ability to meet enrollment targets specific to device and diagnostic trials.
- Retention: A hallmark of professionalism and diligence at the site is essential to ensure optimal patient retention, emphasizing the importance of staff commitment and procedural adherence.
- Data Quality: The site should possess extensive experience, a qualified staff, and robust methodologies to guarantee the highest standards of data collection and management.
Proven Excellence
ClinChoice’s more than 28 years of experience in device and diagnostic clinical investigations conduct has enabled us to develop close links to a large number of high-quality, motivated investigational sites with high recruitment potential. We have a clear understanding of site capabilities on a global scale, ensuring site assignments possess the equipment and skills to perform non-standard clinical procedures.