Regulatory-compliant E2B gateway application extends BioClinica’s eHealth platform.
BioClinica®, Inc., a specialty clinical trials technology and services provider today announced that Vitrana has joined its eHealth App xChangeTM, 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.
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, Inc.
BioClinica is a specialty clinical trials technology services provider that improves the development of new medical therapies by delivering expertise and technologies that enhance clinical research data and analytics, worldwide. The company offers industry-leading medical imaging services, enterprise eClinical technologies, safety and regulatory solutions; patient recruitment and retention, clinical research centers and cardiovascular safety solutions that bring quality and efficiency to every phase of clinical development. BioClinica’s experience spans three decades and includes thousands of studies in all therapeutic areas. 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. Learn more at www.bioclinica.com.