SYNARC scientists developed many of the imaging applications used in osteoarthritis clinical trials today.
SYNARC is the world's largest imaging core lab dedicated to clinical trials. At our centers in the United States, Europe, and Asia, we provide broad panel of imaging for quantifying disease severity and progression at multiple sites in the body. Several of these techniques are unique application developed by our dedicated scientific team.
SynaFlexer™ Digital X-ray Positioning Frame and Phantom
Controls and corrects leading sources of measurement error, including left-right mislabeling and variations in joint flexion, magnification, and x-ray beam angulation.
Syn-X-RA™ Digital X-ray Positioning Frame and Phantom
Ensures reproducible positioning of the hands and prevents left-right mislabeling and variations in x-ray beam centering.
SynaVu™ Digital X-ray Reading System
Provides 21 CFR Part 11 compliant measurement of joint-space width and joint alignment.
SynaVu™ MRI Reading System
Provides 21 CFR Part 11 compliant scoring WORMS (Whole-organ MRI scoring) and quantitative measurement of articular structures.
WORMS for the knee was developed by SYNARC founding scientists. WORMS combines semiquantitative assessments of 11 structural features with high inter-reader reproducibility and sensitivity to change. Our in-house radiologists have more experience than anyone else in evaluating MRI images of the knee for clinical research.
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 four 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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