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Therapeutic Areas

Experience in Vaccine Clinical trials

Vaccine trial experience

Our team has provided imaging CRO services on vaccine clinical trials.  

Combined with our endpoint adjudication and safety committee services, we offer all blinded independent central review of clinical trial data for vaccine trials.

Read team
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 design

Our 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 training

Through 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 platform

Our 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 experience

We 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. 

Learn more
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.

Our Services
Contacts
888.816.4721 | +1.513.924.5183
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