|By Business Wire||
|October 16, 2012 06:07 AM EDT||
BioClinica®, Inc. (NASDAQ: BIOC), a leading global provider of clinical trial management solutions, today announced the immediate availability of new and expanded imaging services critical for clinical trials in the area of osteoarthritis (OA), a disease affecting over 21 million people in the United States.
Colin G. Miller PhD FICR CSci, Senior Vice President of Medical Affairs, commented “BioClinica has been actively involved in the OA Imaging field for both Disease Modifying Osteoarthritis Drugs (DMOADs) and cartilage repair for years. We have amassed a thorough understanding of the FDA requirements and the challenges for these clinical trials. A new proprietary BioClinica positioning device was specifically developed to provide highly reproducible radiographs of subjects’ knees and address the requirements of demanding DMOAD imaging endpoints.”
Development of novel DMOADs requires acquiring highly reproducible plain film radiographs capable of showing joint space narrowing changes of less than 0.2 mm per year. BioClinica’s experience in these studies led to the development of the new system. The use of this device ensures that patients are positioned correctly and consistently at each visit so that even minimal changes will be accurately measured. The proprietary BioClinica positioner supersedes other positioning devices which have shown significant manufacturing variances and hence positioning variability. Both the quality of the positioner results and BioClinica’s methodology in support of one of the largest Phase II studies in this area were recently presented at the OA Imaging workshop in Hilton Head, SC.
BioClinica’s collaboration with Key Opinion Leaders has also been critical for the successful evaluation of these compounds. One of the most extensively published researchers in OA Imaging, Dr. Ali Guermazi of the Boston Medical Center, was quoted “Conducting clinical trials in OA is challenging both from the radiologist point of view and core lab requirements. BioClinica has repeatedly demonstrated the highest commitment to detail which ensures that as a radiologist I can rely on the image quality to optimize the reading of these challenging and complex studies.”
In 2011 the FDA put a clinical hold on osteoarthritis trials that were testing a new class of compound, anti-Nerve Growth Factors (NGFs), after there was a finding of Rapidly Progressing OA (RPOA) in a small subset of subjects. Earlier this year, following an open hearing, the FDA lifted the clinical trial hold for this class of compound with the requirement that all new clinical trials testing this class of compound include a complete radiographic safety evaluation in all subjects enrolled in studies. BioClinica’s direct experience uniquely positions the company to provide full support for clinical studies using either MRI or X-ray evaluations.
Mark L. Weinstein, President and CEO of BioClinica commented, “BioClinica’s capabilities and experience puts us at the forefront of OA research. BioClinica delivers accurate results using therapeutic teams who concentrate specifically on osteoarthritis to focus the expertise necessary to support these clinical trials. We constantly invest in our systems that cover the complete clinical trial workflow -- from patient visit tracking and image acquisition, to capturing the analyses used to evaluate efficacy and safety -- to best support the imaging requirements of the largest studies.”
About BioClinica, Inc.
BioClinica, Inc. is a leading global provider of integrated, technology-enhanced clinical trial management solutions. BioClinica supports pharmaceutical and medical device innovation with imaging core lab, internet image transport, electronic data capture, interactive voice and web response, clinical trial management and clinical supply chain design and optimization solutions. BioClinica solutions maximize efficiency and manageability throughout all phases of the clinical trial process. With over 22 years of experience and more than 2,500 successful trials to date, BioClinica has supported the clinical development of many new medicines from early phase trials through final approval. BioClinica operates state-of-the-art, regulatory-body-compliant imaging core labs on two continents, and supports worldwide eClinical and data management services from offices in the United States, Europe and Asia. For more information, please visit www.bioclinica.com.
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