OpenClinica is cost-effective and flexible, allowing us to re-use and modify eCRFs for other clinical studies.
(PRWEB) July 24, 2012
OpenClinica, LLC announces that HemCon Medical Technologies Inc., a leading provider of products for severe hemorrhage control resulting from severe trauma or surgery, and developer of lyophilized (freeze-dried) plasma (LyP) for the U.S. Army, has selected the OpenClinica Enterprise Edition to facilitate electronic data capture and clinical data management in its LyP clinical studies.
The LyP program is developing a freeze-dried plasma that quickly reconstitutes for use in patients who require replacement of multiple plasma coagulation factors. This project is funded by the U.S. Army, and research shows that early administration of plasma has an important role in reducing battlefield mortality rates as well as in civilian trauma and surgery. HemCon’s hemorrhage control products have improved the standard of care in both military and civilian settings where rapid control of bleeding is of critical importance.
OpenClinica, LLC is the provider of the fastest growing clinical trial software. The web-based OpenClinica software is used in diverse clinical research settings worldwide by leading biopharmaceutical and medical devices companies, contract research organizations, government, and non-profit groups to facilitate the electronic capture and management of clinical data.
“We are confident that OpenClinica Enterprise will be a great tool to capture and summarize the data for our upcoming Phase 2 LyP clinical trial,” said Jody Oyama, Vice President, Clinical Affairs at HemCon. “It is an effective and easy-to-use software that allows us to exercise greater control throughout the study design and operations process, and maintain regulatory compliance. Moreover, the OpenClinica system is cost-effective and flexible, allowing us to re-use and modify eCRFs for other clinical studies.”
Following completion of a successful Phase 1 clinical trial last year, HemCon is preparing for the upcoming Phase 2 study.
“We are excited to be working with HemCon. Their products serve vital role that we are proud to be a part of,” said Cal Collins, OpenClinica’s CEO.
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HemCon Medical Technologies, Inc. (http://www.hemcon.com) founded in 2001, develops, manufactures, and markets innovative technologies that control bleeding resulting from trauma or surgery. HemCon’s products are designed for use by both military and civilian first responders as well as medical professionals in hospital and clinical settings where rapid supply of plasma and control of bleeding are of critical importance. HemCon is headquartered in Portland, Oregon, with offices in Ireland and the Czech Republic.
OpenClinica enhances the productivity of clinical trials through commercial open source software. Trusted by hundreds of 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.