NEWTOWN, Pa.--(BUSINESS WIRE)--BioClinica®, Inc. (NASDAQ: BIOC), a global provider of clinical trial management solutions, today announced that Onconova Therapeutics®, Inc. has extended agreements using BioClinica Express electronic data capture (EDC) and data management services to support their clinical trials world-wide. Onconova has a number of clinical-stage products and a growing number of pre-clinical candidates. These development stage compounds are novel small molecules for the treatment of a broad range of hematologic malignancies and solid tumors.
“We collaborate with a number of Clinical Research Organizations,” said Dennis C. Earle, Vice President of Clinical Operations at Onconova, “so using BioClinica Express for our trials has helped us to standardize processes. BioClinica has been flexible and responsive, implementing a collaborative, real-time UAT (user acceptance testing) process to help Onconova meet study launch timelines. BioClinica’s Forms and Study Design Team, in conjunction with the Data Management team, have worked together to ensure optimal use of the technology while re-using established eCRFs (electronic case report forms) in order to support rapid study builds.”
Onconova has benefited from a number of eCRFs and tools developed by BioClinica specifically to support oncology trials. BioClinica Express EDC offers standard RECIST (Response Evaluation Criteria In Solid Tumors) eCRFs that automatically calculate overall tumor response based on the data entered. A dynamic lesion form uses derived data to help sites consistently track lesions from visit to visit. BioClinica’s preconfigured library of oncology forms also includes functionality that guides sites through adding adverse events in a way that eliminates the coding step required when entering verbatim terms, and allows the site to fully understand the National Cancer Institute CTCAE (Common Terminology Criteria for Adverse Events) grades available for each particular event. BioClinica also worked with Onconova to develop a custom study drug re-supply algorithm to support its unique study design, implemented a daily lab import feed to minimize data entry and a local lab range import to streamline reconciliation.
"The approach being employed by Onconova represents some of the most innovative cancer research in the country, and we are proud to support those efforts," said Peter Benton, President of eClinical Solutions for BioClinica. "The selection of BioClinica by Onconova reaffirms our cutting-edge and user-friendly technology. It also demonstrates BioClinica’s ability to deliver effective clinical research solutions for sponsors and Clinical Research Organizations of any size, and for all clinical trial phases and therapeutic categories."
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About Onconova Therapeutics®, Inc.
Onconova, based in Newtown, PA and Pennington, NJ, and founded in 1998, discovers and develops novel small molecule therapeutics targeting signal transduction, cell-cycle, and DNA repair pathways. Onconova has a novel discovery platform focusing on non-ATP competitive kinase inhibitors. These products, technologies, and candidates are derived internally from a proprietary library of new chemical entities. In addition to rigosertib and other anti-cancer drug candidates, Onconova is also developing Ex-RAD® (ON 01210.Na) as a novel radiation protectant (oral and injection) against radiation injury of tissue and whole body. For additional information, please visit http://www.onconova.com.
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 20 years of experience and more than 2,000 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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