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Bioclinica Demonstrates EHR to CDASH (E2C) Standard

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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 specialty services provider that utilizes expertise and technology to create clarity in the clinical trial process. Bioclinica is organized by three business segments to deliver focused service supporting multifaceted technologies. The Medical Imaging and Biomarkers segment provides medical imaging and cardiac safety services and includes a molecular marker laboratory. The eHealth Solutions segment comprises an eClinical technology platform, a suite of financial lifecycle solutions along with drug safety and regulatory solutions. Under the Global Clinical Research segment, Bioclinica offers a network of research sites, patient recruitment-retention services, and a post-approval research division. The Company serves more than 400 pharmaceutical, biotechnology and device organizations – including all of the top 20 – through a network of offices in the U.S., Europe and Asia.

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Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

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