musculoskeletal
MSK Imaging Expertise
Our team has successfully conducted registration trials in MSK involving thousands of sites and tens of thousands of participants.
Experience Across MSK Indications
Our team has provided imaging CRO services on dozens of Musculoskeletal clinical trials utilizing imaging in Phases I-IV. We have extensive experience with trials in Arthritis, Ankylosing Spondylitis, Bone Fractures, Bone Safety, Gout, Orthopedic, Osteoarthritis, Osteoporosis, Rheumatoid Arthritis, and other MSK clinical trials, including registration trials in both the U.S. and Europe
Modalities
We have extensive experience with bone scans, DXA, X-Ray, MRI, CT, MRE in MSK trials and imaging for arthritis trials. Our analysis and reading capabilities include measurements of bone mineral density, muscle and fat segmentation, fracture scoring, fracture-healing, joint-space width measurements, and more. Our services also include safety monitoring, including bone loss, t-score, z-score, and fracture reporting.
Evaluation Criteria Expertise
We have experience with a variety of musculoskeletal evaluation criteria, including:
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· ASspiMRI
· Bone Erosions
· Bone Marrow Edema Assessments
· Cartilage Thickness
· Changes in Nucleus Pulposus
· Disc Height & Morphology
· DXA-Related Assessments
· Fractures
· extended MRI Scale (eMRI Score)
· Hemophilia Early Arthropathy Detection by Ultrasound (HEAD-US)
· Int’l Prophylaxis Study Group (IPSG) MRI scale
· Joint Space Narrowing
· Kellegren & Lawrence
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· MGruelich and Pyle (Bone Age)
· Modic Score
· NY Criteria
· OARSI
· Petterson Score
· Pfirrmann score
· Radiologic Classification of Hemophilic Arthropathy
· RAMRIS
· Safety
· SHARP
· Stoke AS Spine Score (SASSS)
· van der Heijde
· Verbruggen Anatomic Phase Scoring System (GUSS)
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. Our services also include safety monitoring. 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.
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.
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.