With OpenClinica, we are able to put in place an enterprise-quality, regulatory compliant electronic data capture and clinical data management system that will make us more attractive to both government-sponsored and industry-sponsored clinical trials
Waltham, MA (PRWEB) October 17, 2011
The Michigan Institute for Clinical & Health Research (MICHR) at the University of Michigan has selected the OpenClinica Enterprise clinical trial software platform to support a growing clinical study portfolio. Starting this fall, MICHR will begin deployment of OpenClinica for a wide variety of clinical trials.
According to Jim Maszatics, Clinical Research Informatics Core (CRIC) Manager at MICHR, OpenClinica offers a robust infrastructure that will enhance MICHR’s competitiveness for extramural funding. “Static budgets and budget cuts from the NIH are causing government-sponsored grants to become more competitive than ever. With OpenClinica, we are able to put in place an enterprise-quality, regulatory compliant electronic data capture and clinical data management system that will make us more attractive to both government-sponsored and industry-sponsored clinical trials.”
In addition to its regulatory compliance capabilities, MICHR cited OpenClinica’s flexibility to support a wide variety of studies off the same platform, thereby increasing the institute’s efficiency. This efficiency will serve MICHR well in its support of a large and growing number of diverse clinical studies.
“We are thrilled to be working the MICHR,” said Ben Baumann, Co-Founder and Director of Business Development for OpenClinica. “OpenClinica is a natural fit for groups that conduct both regulatory and non-regulatory studies under the same roof. MICHR will gain a competitive advantage while increasing the effectiveness of its clinical trial operations.”
OpenClinica is the world’s most popular open source clinical trial software for web-based electronic data capture and clinical data management. Since 2010 there has been a 10-fold increase in OpenClinica-powered trials that were part of submissions to regulatory agencies such as the FDA. The growth is also indicated in the number of people and organizations that have joined the OpenClinica online community—now over 12,000.
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.
The Michigan Institute for Clinical & Health Research provides 360º support for every phase of clinical & translational research – from consultation on an idea to helping promoting results. MICHR educates, funds, connects, and supports research teams across the University of Michigan. MICHR’s team consisting of more than 100 professional staff and 65 faculty moves medicine forward to improve health treatments and find cures. MICHR was created in 2006 and received a Clinical & Translational Science Award from the National Institutes of Health in 2007, making it part of a national consortium of 60 academic research institutions working together to translate discoveries into health gains. For more information, visit http://www.michr.umich.edu or follow @UM_MICHR on Twitter.