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Therapeutic Expertise |
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Infectious Diseases (HIV) |
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SYNARC is the world leader in imaging core lab services for rheumatoid arthritis studies.
SYNARC is the world's largest imaging core lab dedicated to clinical trials. SYNARC performed the first large multicenter clinical trial in rheumatoid arthritis using MRI, and helped develop the MRI scoring method recommended by EULAR and OMERACT. The Genant-modified Sharp scoring method was developed by SYNARC's founding scientists. The scoring method has been used in multiple clinical trials, and helped gain regulatory approval for Orencia® (abatacept) as well as for Rituxan® (rituximab) and MabThera® (rituximab) for use in rheumatoid arthritis. SYNARC also conducts clinical trials using other methods, including van der Heijde–modified Sharp scoring. Through our experienced project managers, scientific staff, and in-house and external radiologists, we provide our clients with the industry's highest quality of service involving X-ray, MRI and other imaging modalities central to the success of rheumatoid arthritis clinical trials.
StudyDirect
StudyDirect is our 21 CRF Part 11 clinical imaging management system which provides state-of-the-art image analysis tools for our in-house and external radiologists. With more than five million images uploaded through our Web portal, SynarcConnect, we work with sites throughout the world to effectively capture high-quality images and data to efficiently meet your timelines. Our industry-leading, Web-based reporting provides you with the immediate insight into key metrics relating to your study to ensure timelines are met.
Regulatory compliance
SYNARC's systems and processes have been audited hundreds of times by the world's leading pharmaceutical and medical device companies, as well as the FDA and EMA. An imaging provider's quality management system is a key requirement for successful regulatory submissions. Our expertise in dealing with global agencies' procedures will help your organization navigate the regulatory approval process more effectively and cost efficiently.
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- Erosion, osteitis, and synovitis scoring
- Quantitative assessment of synovitis
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