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Bioclinica Demonstrates EHR to CDASH (E2C) Standard

Express EDC achieves E2C Standard

January 6, 2016

Bioclinica®, Inc., a specialty clinical trials technology and services provider, today announced the demonstration of its Electronic Data Capture (EDC) system, Express, to map information from the Electronic Health Record (EHR) Continuity of Care Document (CCD) to CDASH Clinical Research Forms (CRFs). The real-world demonstration of using select data on the 17-section CCD to pre-populate case report forms comes as welcome news to the research community seeking to streamline design and data collection.

Bioclinica E2C solution demonstrated by Jen Price and Bioclinica's Express EDC team at the 2015 CDISC International Interchange draws crowd, including Dr. Stephen Wilson, Director, FDA/CDER/DBIII.

"The ability to easily read and pull in data from the EHR documents to Express EDC in the CDASH standard format is particularly appealing to organizations dealing with great volumes of data," said Bioclinica Senior Vice President of Product Development and Technology Andrew Masters. "This allows research sites to upload files without having to enter the data in two different systems. "Automation replaces manual transcription, thereby eliminating errors and redundant work, which can add up to big savings."

Clinical Data Acquisition Standards Harmonization (CDASH) is a standard used to collect patient-based clinical research data. The collected data can be easily transcribed to the CDISC Study Data Tabulation Model (SDTM) standard required for FDA submissions.

Bioclinica was a member of the CDISC E2C team formed in May 2015, tasked with mapping demographics and vital signs, adverse events, concomitant medications, and medical history from the EHR CCD to CDASH CRFs. The pilot tested the use of the CCD as one way to obtain a source document from the EHR. The results from the E2C standard demonstration were publically unveiled during the CDISC International Interchange 2015 held in Chicago last November.

"We are delighted to make E2C a reality for our sponsors and CRO partners,"

- said Bioclinica Director of Clinical Solutions Jennifer Price, who led the Bioclinica demonstration

The E2C solution will become available in an upcoming release of Express. "We are ready to apply this to any clinical trial scenario. With forward-thinking sponsors already asking about site training we anticipate wide adoption of the Bioclinica E2C solution."

The initiative aligns with the FDA Guidance for Industry: Electronic Source Data in Clinical Investigations, issued in September 2013. Find out more about Bioclinica and its support of standards in clinical trials on the Trial Blazers blog at http://www.bioclinica.com/blog, and on Twitter at http://twitter.com/bioclinica.

About Bioclinica

Bioclinica is a global life sciences solution provider that utilizes science and technology to bring clarity to clinical trials – helping companies to develop new life-improving therapies more efficiently and safely. Successful clinical trials require the ability to see key details and uncover hidden insights, and Bioclinica’s hundreds of experienced scientific, medical, and domain experts bring unmatched insight across the development lifecycle, from the initial protocol to post-approval.  The company’s cloud-based offerings include medical imaging; cardiac safety; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site payments and forecasting; pharmacovigilance; trial management; and risk-based monitoring solutions. A true multifaceted partner to trial sponsors and Contract Research Organizations (CROs), Bioclinica offers a global network of research sites, patient recruitment services, and post-approval research expertise to provide committed, detail-focused service through all stages of drug development.  The company’s thousands of employees serve more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 biopharmaceutical companies and leading CROs – through a network of offices in the U.S., Europe, and Asia.

Learn more about Bioclinica and our Clinical Adjudication and other offerings at www.Bioclinica.com and in the Bioclinica Blog. Follow the latest company news and happenings on LinkedIn and Twitter.

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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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