We are leading providers of imaging services for medical device trials.
Medical device trial experience
Our team has provided imaging CRO services
on dozens of global Class I-III medical device trials for cardiovascular, CNS, and MSK device trials.
We have experience with a wide variety of medical device trials, including those involving: Stents, mesh, CAD, Catheter, Clips, and mobile systems. We've used a variety of modalities in medical device trials, including CT, MRI, Mammograms, PE, Angiogram, Ultrasound, Echos, Cavogram, Spot Film, and X-Ray.
Our dedicated team of radiologists, technicians, regulatory experts, and project managers is among the most knowledgeable and well-respected in the industry. Our services also include safety monitoring.
Study designOur experts work with sponsors to design trials which ensure high-quality results in a cost-effective manner. We collaborate with sponsors in workflow design and imaging charter development to establish the foundation necessary to meet the sponsor's clinical trial goals.
Reader trainingThrough a combination of our expert radiologists and our rigorous training and testingregimen, we are committed to increasing the accuracy and precision of data subject to blinded independent central review. Sponsors have the flexibility of working with our highly-trained in-house radiologists, with sub-specialty-trained board-certified radiologists from the Harvard Hospital System, or with other radiologists of the sponsor's choice.
Web-based technology platformOur state-of-the-art systems are 21 CRF Part 11 compliant and are used to analyze images from all modalities. The systems can be accessed by radiologists to perform assessments anywhere in the world. Thousands of clinical sites in the U.S., Latin America, Europe, and Asia-Pacific have uploaded imaging data directly into our secure system.
Regulatory experienceWe have an extensive history in preparing submissions for regulatory approval by the U.S. Food and Drug Administration (FDA) Medical Imaging Division and the European Medicines Agency (EMA). Our Quality Management System is designed to provide the structure and controls required to support execution of the clinical study, while ensuring that processes meet current regulatory standards.
You can learn more about imaging in medical device clinical trials by reviewing our publications below. To learn more about our medical device services, please contact us at +1.888.816.4721.