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Bioclinica Announces Vitrana Joins eHealth App xChange

Regulatory-compliant E2B gateway application extends Bioclinica's eHealth platform

November 10, 2015

BioClinica®, Inc., a specialty clinical trials technology and services provider today announced that Vitrana has joined its eHealth App xChange™, an alliance channel for technology innovation across life sciences and healthcare. Vitrana's E2B Transformation and Gateway Application will be offered as part of BioClinica's transformative eHealth Cloud™ solutions.

"Vitrana applications ease the transition to universal information management and exchange standards adoption, and in partnering we're bringing this innovation to clinical trials and safety information processing," said BioClinica Global Product Development Senior Vice President Andrew Masters. Vitrana's application transforms E2B R2 messages into HL7 v3 formats for both regulatory agency submission and partner organization exchange in a secure way. "Sponsors can submit their ICSRs electronically via the E2B Gateway, meeting compliance criteria using new E2B R3 standards."

"Integrating a standards-based E2B solution where sponsors can address both agency and partner needs with speed and security was a key factor in our decision to partner on this," Masters explained. The application allows BioClinica customers to submit adverse event messages to regulatory agencies and also exchange this information with partner organizations." A flexible, interoperable transformation engine converts existing datasets to HL7 information exchange standards without adding costs.

"We are excited about the innovation our partnership brings to clinical trials and drug safety," said Vitrana President and CEO Mohit Gupta. "Making our application available as part of the BioClinica platform eases sponsors' transition to universal information management and exchange standards, alleviating risks, without interrupting their business operations."

"We are pleased to welcome Vitrana as an eHealth App xChange partner," Masters said. The initiative aims to enable research communities to achieve a new level of patient and consumer engagement, helping accelerate pre- and post-approval research Find out more about BioClinica's eHealth App xChange from Chad Ebner, Director of Channel Sales. Follow BioClinica on the Trial Blazers blog at http://www.bioclinica.com/blog, and on Twitter at http://twitter.com/bioclinica.

About Vitrana
Vitrana is a dynamic Health Sciences IT product and consulting company driving major advances in the quality, efficiency and cost of clinical research and patient care through leveraging key technology innovations in clinical and healthcare information management. The company offers industry-leading life sciences and healthcare consulting services and products for data transformation and exchange, compliance, quality, productivity, data governance and advanced analytics. The company serves more than 15 global pharmaceutical, biotechnology, CRO and healthcare organizations through its offices in the U.S., Europe and Asia. Learn more at www.vitrana.com.

About Bioclinica

Bioclinica is a global life science 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 and cardiac safety services; clinical adjudication; randomization and trial supply management and optimization; electronic and eSource data capture; site and patient payments and budget 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 and patient recruitment services 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 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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