BioClinica, Inc., a global provider of clinical trial management solutions, 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 selection of BioClinica by Onconova demonstrates our 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.”
Date: November 30, 2011
Source: BioClinica Inc.