Onconova uses BioClinica EDC, data management services to support clinical trials

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."

Source: Onconova Therapeutics, Inc.

Citations

Please use one of the following formats to cite this article in your essay, paper or report:

  • APA

    Clario. (2011, December 01). Onconova uses BioClinica EDC, data management services to support clinical trials. News-Medical. Retrieved on November 02, 2024 from https://www.news-medical.net/news/20111201/Onconova-uses-BioClinica-EDC-data-management-services-to-support-clinical-trials.aspx.

  • MLA

    Clario. "Onconova uses BioClinica EDC, data management services to support clinical trials". News-Medical. 02 November 2024. <https://www.news-medical.net/news/20111201/Onconova-uses-BioClinica-EDC-data-management-services-to-support-clinical-trials.aspx>.

  • Chicago

    Clario. "Onconova uses BioClinica EDC, data management services to support clinical trials". News-Medical. https://www.news-medical.net/news/20111201/Onconova-uses-BioClinica-EDC-data-management-services-to-support-clinical-trials.aspx. (accessed November 02, 2024).

  • Harvard

    Clario. 2011. Onconova uses BioClinica EDC, data management services to support clinical trials. News-Medical, viewed 02 November 2024, https://www.news-medical.net/news/20111201/Onconova-uses-BioClinica-EDC-data-management-services-to-support-clinical-trials.aspx.

Comments

The opinions expressed here are the views of the writer and do not necessarily reflect the views and opinions of News Medical.
Post a new comment
Post

While we only use edited and approved content for Azthena answers, it may on occasions provide incorrect responses. Please confirm any data provided with the related suppliers or authors. We do not provide medical advice, if you search for medical information you must always consult a medical professional before acting on any information provided.

Your questions, but not your email details will be shared with OpenAI and retained for 30 days in accordance with their privacy principles.

Please do not ask questions that use sensitive or confidential information.

Read the full Terms & Conditions.

You might also like...
BioClinica second quarter service revenues increase 8.7% to $16.9 million