HIPAA News

StatWorks Selects OpenClinica Enterprise to facilitate EDC for Industry-Sponsored Clinical Trials

(March 07, 2008)-- Contract research organization (CRO) specializing in statistical and data management services, StatWorks has selected HIPAA Compliant OpenClinica Enterprise to facilitate Electronic Data Capture (EDC) for industry-sponsored clinical trials. OpenClinica supports HIPAA and 21 CFR Part 11 guidelines and is designed as a lightweight, standards-based, extensible, and modular platform. StatWorks is one of the latest in a growing roster of CROs to rely on OpenClinica to power their clinical studies.

"OpenClinica Enterprise allows our company to benefit from a flexible, high quality EDC solution without assuming the risks inherent in proprietary technology and ongoing license fees," said Mark Paul, StatWorks' Chief Executive Officer. "We view OpenClinica as a long term strategic component to our company's continued growth."

Contract Research Organizations appreciate OpenClinica's flexible ability to support diverse clinical studies. The OpenClinica software makes it easy to quickly deploy studies, re-use study components like case report forms (CRFs), and operate multiple studies from a single system. The software can be set-up once and used in numerous studies without having to worry about large incremental costs.

OpenClinica Enterprise allows CROs and other clinical research organizations to obtain a spectrum of services (such as training, study set-up, and validation support) to enhance their use of the OpenClinica software. With OpenClinica Enterprise, an organization can maintain its independence from a software vendor while obtaining full support for a modern, robust clinical research technology platform. OpenClinica Enterprise products and services are delivered by Akaza Research of Cambridge, Massachusetts.

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