Kuno van der Post Ph.D
OmniComm Systems, Inc.
Fort Lauderdale, FL, September 17, 2012 – OmniComm Systems, Inc., one of the fastest growing companies in the Electronic Data Capture (EDC) marketplace, today announced a new enterprise agreement with the Consortium of Rheumatology Researchers of North America, Inc. (CORRONA) for the use of OmniComm’s TrialMaster Suite® of eClinical applications for all CORRONA registry studies.
Changing federal guidelines, with respect to pharmacovigilance and safety monitoring, are causing many organizations within the pharmaceutical, biotech, medical device and academic medical industry to rethink their requirements and the underlying technology used for collecting data for registries and other post-marketing studies. “Unfortunately, many older registry and post-marketing studies were developed on custom-built, home grown software platforms which were initially designed to be budget-conscious, often at the expense of industry compliance and usability,” said Stephen Johnson, President & COO of OmniComm Systems. “They weren’t designed to support the unique requirements that disease registries demand. Today, due to these changing safety requirements, Electronic Data Capture (EDC) software used for registry and post-marketing studies needs to be not only budget conscious and flexible, but 21 CFR Part 11 and regulatory compliant as well. OmniComm’s TrialMaster EDC Suite is exactly that: feature-rich, easy-to-use, flexible, competitively-priced and industry compliant.”
CORRONA's mission is to advance rheumatology research and improve the quality of rheumatology patient care. Selecting the right EDC solution for these long-term Registries is critical to the organization’s success. “The combination of flexibility and rock solid stability made TrialMaster a logical choice for us. The stresses of a large global disease registry are unique and cause most EDC systems to not even make the first cut. After a lengthy evaluation and selection process, we felt that OmniComm’s technology, backed by a focus on strong customer support, were the best fit for our company. We look forward to a long and productive relationship with OmniComm,” said Jim Cavan, COO of CORRONA.
OmniComm has already begun working with CORRONA on the design of the first three registries for 2012, with planned expansion to launch three more registry studies soon thereafter.
The current disease registry studies being built for CORRONA include:
- • A Core Registry of Rheumatoid Arthritis (RA) and Psoriatic Arthritis of approx. 38,000 patients with approx. 90,000+ patient years of data
- • The CERTAIN Comparative Effectiveness, sub-study, Registry of 3,000 patients
- • CORRONA International RA with associated Cardiovascular Comorbidities Registry of 5,700 patients in India, Central / Eastern Europe, Mexico, and South America
OmniComm Systems, Inc. (www.OmniComm.com) provides customer-driven Internet solutions to pharmaceutical, biotechnology, and medical device organizations that conduct life changing clinical trial research. OmniComm's growing base of satisfied customers is a direct result of the company's commitment to deliver products and services that ensure ease of use, faster study build, ease of integration and better performance. OmniComm Systems, Inc. has U.S. headquarters in Fort Lauderdale, FL and European headquarters in Bonn, Germany, with satellite offices in New Jersey and the United Kingdom, as well as sales offices throughout the U.S. and Europe.
The Consortium of Rheumatology Researchers of North America, Inc. (CORRONA) (www.corrona.org) was founded in 2000 by leading rheumatologists dedicated to advancing and improving the care of patients with rheumatic diseases. CORRONA's mission is to advance rheumatology research and improve the quality of rheumatology patient care. CORRONA is an independent registry without any ownership links to the pharmaceutical industry.
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