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OpenClinica announces that K&L Consulting Services, Inc. (“K&L”) of Fort Washington, Pennsylvania, has selected the OpenClinica Enterprise Edition for Electronic Data Capture (“EDC”) and clinical data management for Phase I-IV clinical trials. K&L is a Contract Research Organization (“CRO”) for clinical trial Sponsors, providing end-to-end services for all types of clinical studies, as well as post-marketing pharmacovigilance support and outcomes research.
K&L is increasing the breadth of its capabilities in the US as well as in Asia and the Pacific region, especially in China. “We welcome this opportunity to work closely with K&L to help them grow their global practice,” said Ben Baumann, Chief Operating Officer at OpenClinica, LLC.
When asked what attracted K&L to OpenClinica Enterprise, Vice President of Biostatistics and Data Management, Dr. Henry Wu said “OpenClinica Enterprise allows us to deploy studies quickly and cost effectively, and pass this value on to our clients.” OpenClinica’s innovative commercial open source model stands out in the realm of clinical research software. The company’s strategy is to leverage its rapidly growing global community of users and developers (currently comprising nearly 17,000 people) in order to produce high quality software in a more agile and transparent way for use across the spectrum of clinical research.
The OpenClinica software is available in two editions: The OpenClinica Community Edition is freely available under a common open source license. The OpenClinica Enterprise Edition pairs the open source technology with a regulatory compliance infrastructure and robust support services. According to Baumann, “OpenClinica’s model allows us to focus on what makes EDC software successful--how it is implemented and supported.”
About K&L Consulting Services, LLC
K&L Consulting Services, Inc. is a Contract Research Organization (“CRO”) offering Data Management, Biostatistics, Statistical Programming and Medical Writing as well as CDISC compliant eSubmission services to the pharmaceutical, biotechnology and medical device industries worldwide. K&L’s services encompass end-to-end solutions utilizing industry data standards and rigorous operating procedures that enhance Clients’ ability to get their products approved faster at minimum risk and lower cost in order to meet patients’ needs for advanced medicines. More information at http://www.klserv.com.
About OpenClinica, LLC
Waltham, Massachusetts-based OpenClinica, LLC enhances the productivity of clinical trials through commercial open source software. With over 1,000 implementations at biopharmaceutical companies, contract research organizations, academic, and government organizations worldwide, the OpenClinica software facilitates electronic data capture and data management, increasing the speed of collection and quality of data in clinical trials. OpenClinica supports HIPAA, 21 CFR Part 11, and other regulatory guidelines and is designed as a standards-based, extensible, and modular platform. For more information – including product and source code downloads – visit http://www.openclinica.com or follow @OpenClinica on Twitter.