The OpenClinica system should enable us to collect data from participating clinical trial sites faster and with a higher level of quality.
Waltham, MA & Wollerau, Switzerland (PRWEB) January 04, 2013
OpenClinica, LLC and Shield Therapeutics announces that Shield Therapeutics has selected the OpenClinica Enterprise software for its clinical data management needs related to the company’s clinical trials. Shield Therapeutics develops treatments for unmet medical needs, and is currently running a Phase III program for ST10, a novel orally delivered ferric iron-based therapy to treat iron deficiency.
“The OpenClinica system should enable us to collect data from participating clinical trial sites faster and with a higher level of quality,” said Carl Sterritt, Shield’s CEO. “We also hope that an added benefit of the OpenClinica Enterprise Edition will be facilitation of our regulatory compliance efforts.”
OpenClinica offers a unique and flexible model for its clinical trial software. “As commercial open source software, OpenClinica allows organizations like Shield Therapeutics to benefit from powerful, widely adopted, open source technology, while obtaining a fully supported implementation and a robust regulatory infrastructure, said Cal Collins, CEO at OpenClinica, LLC. “We are excited to welcome Shield Therapeutics to our rapidly growing community and Enterprise customer base.”
About Shield Therapeutics®
Shield Therapeutics is a Swiss-based specialty pharmaceutical company focused on the development and commercialization of novel mineral-based therapies to treat diseases with significant unmet medical need. The company was founded in 2008 and is currently undertaking a multi-national pivotal Phase III program for its lead asset, ST10, for the treatment of iron deficiency anaemia (IDA) associated with inflammatory bowel disease (IBD). For more information see http://www.shieldtx.com.
OpenClinica 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 downloads – visit http://www.openclinica.com or follow @OpenClinica on Twitter.