BioClinica

BioClinica, Inc., formerly Bio-Imaging Technologies, Inc., founded in 1990, is a Pennsylvania-based company that supports pharmaceutical and medical device innovation.

BioClinica’s initial service was medical imaging for clinical trials. It is used to capture, collect, control quality, provide blinded reading services to the final delivery to the sponsor company and to the FDA or EMEA if required for medical images in a wide range of imaging modalities.

Locations

BioClinica is headquartered in Newtown, Pennsylvania, and also has offices in Audubon, Pennsylvania; Fall River, Massachusetts, Leiden, Netherlands, and Lyon, France.

Management

Mark Weinstein has served as president and CEO since February 1998 and has been a member of the Board of Directors since March 1998. Mr. Weinstein joined Bio-Imaging Technologies, Inc. in June 1997 as Senior Vice President of Sales and Marketing. Prior to joining Bio-Imaging Technologies, Inc., he was the Chief Operating Officer of Internet Tradeline, Inc., an internet-based electronic solutions provider. Mr. Weinstein received his Bachelors degree in Economics from the University of Virginia and his MBA from the College of William and Mary.

History

In 1999, BioClinica completed its acquisition of Bona Fide, Ltd. Bona Fide providing quality assurance and quality control (QA/QC) services for clinical trials requiring bone densitometry utilizing Dual Energy X-ray Absorptiometry (DEXA), including trials of musculoskeletal disorders, obesity and wasting diseases. Founded in 1993, Bona Fide, Ltd., had been a wholly owned subsidiary of the LUNAR Corporation.

In 2001, BioClinica purchased the Intelligent Imaging business of Quintiles Transnational Corp. (Nasdaq: QTRN). Intelligent Imaging specialized in providing digital medical imaging services for clinical trials and the health care industry. Their services include image data management, data translation and digitization for submission of medical image data to the U.S. Food and [...] Administration and clinical sponsors using proprietary interactive software.

In 2003, BioClinica acquired the intellectual property of privately held CapMed located in Wilmington, DE, including the Personal Health Record (PHR) software and the patent-pending Personal HealthKey™ technology.

In 2004, BioClinica acquired Heart Core B.V., a leading global provider of centralized imaging analysis services in the field of cardiovascular, pulmonary and orthopedic clinical research. Heart Core was partly owned by Libertatis Ergo Holding, a wholly owned holding of the University of Leiden. Heart Core specializes in a various quantitative image analysis services including: Quantitative Coronary Angiography (QCA), Cardiac MRI and CT, Ultrasound, Intravascular Ultrasound (IVUS) and Peripheral Quantitative Angiography (QVA). Founded in 1996 and headquartered in Leiden, The Netherlands, Heart Core also has expertise in ECG analysis, nuclear medicine and orthopedics.

In 2007, BioClinica acquired Theralys SA, a provider of customized imaging services in the field of central nervous system disorders (“CNS”) and Nervous system disorders. Theralys' proprietary image processing image processing software enables the introduction of quantitative imaging markers in the design of clinical trials for Neurovascular and CNS disorders, including stroke, secondary prevention drugs, multiple sclerosis and dementia including Alzheimer's disease (AD). Their proprietary and validated software for clinical trials includes applications which enable the automated quantification of various imaging parameters such as brain, white matter lesion and hippocampal volumes, MRI diffusion and perfusion, etc. Such measurements are currently used by pharmaceutical and biotechnology companies in ongoing phase II-III-IV trials in neurodegenerative diseases for the evaluation of response to therapy and/or indicators of disease progression over time.

In 2008, BioClinica acquired privately held Phoenix Data Systems, Inc., a global clinical data services provider of electronic data capture (EDC) services and a comprehensive array of broadly interoperable eClinical data solutions to the pharmaceutical and biotechnology industries. Founded in 1997 and headquartered in nearby King of Prussia, PA, Phoenix Data Systems delivers full service EDC, a unique combination of electronic data capture, interactive voice response, reporting, and data management services that give clinical data managers improved control to run well-managed studies. Phoenix Data assists its pharmaceutical, biotechnology, medical device and contract research organization clients with streamlining the clinical research process by providing early visibility to reliable clinical research data.

In 2009, BioClinica sold its CapMed Division (“CapMed”) to Metavante Technologies, Inc.

BioClinica also re-branded to become BioClinica from the previous company name, Bio-Imaging Technologies, Inc.

Later that year, BioClinica acquired the CardioNow unit of Agfa HealthCare. With this addition, BioClinica offers streamlined electronic transport solutions to facilitate the blinding, sharing, tracking and archiving of medical images for multi-center clinical trials as part of its suite of imaging services. Imaging information will also be integrated with BioClinica Express electronic data capture to further simplify and enhance the clinical trial process for life science companies.

BioClinica then acquired privately held Tourtellotte Solutions, Inc. (Tourtellotte). Tourtellotte, headquartered in Wayland, MA and with additional operations in Bhubaneswar, India, provides software applications and consulting services which support pharmaceutical development. In 2001, Tourtellotte pioneered the first major parameter-driven IVR and the world’s first IWR for a top five global pharmaceutical company. In 2007, Tourtellotte introduced tcVisualize, a product which allows biopharmaceutical companies to simulate and optimize the clinical supply chain. tcVisualize allows study managers to develop the perfect clinical supply plan resulting in reducing product waste, trial delays, and lost patient enrollment due to product stockouts. In 2010, BioClinica acquired TranSenda International, LLC. Headquartered in Bellevue, WA, TranSenda is a provider of clinical trial management software (CTMS) and is a Microsoft Gold Certified Partner. TranSenda’s web-based Office-Smart CTMS and patent-pending integration technologies create efficiencies for trial operations through interoperability with Microsoft Office tools.

BioClinica currently operates regulatory-body-compliant imaging core labs on two continents, and supports worldwide eClinical and data management services from offices in the United States, Europe

References

Business data