On-X saves over $2 million in conducting the company’s prosthetic heart valve clinical trials – a phase IV and safety registry – with TEMPO research platform from Clinipace
July 31, 2008 / Research Triangle Park, NC — Clinipace, a growing on-demand clinical research software company, today announces that On-X Life Technologies has saved over $2 million in direct and indirect costs associated with conducting two research studies using TEMPO – Clinipace’s software platform.
Upon receiving the U.S. Food and Drug Administration (FDA) approval in early 2006 to conduct an investigational device exemption (IDE) clinical trial of the On-X® Prosthetic Heart Valve at reduced anticoagulation levels following review and approval by clinical centers, On-X began the process of evaluating partners to assist with study management.
The randomized control clinical trial involves up to 1,200 patients across 40 different medical centers nationwide, and the team originally pursued an outsource management strategy due to the perceived complexity of the project. However, after several weeks of cost analysis and market research, John Ely, Executive Vice President for Regulatory Affairs at On-X Technologies decided to take a different path – due to the significant cost – and manage the study internally with On-X employees and clinical research software.
“We had to find the right software partner to work with us,” John Ely said. “We wanted a web-based solution without all the upfront and long-term costs usually associated with packaged software. As a small medical device company, we needed a partner who understood our business cycle and company stage.”
After researching five vendors, On-X chose Clinipace’s TEMPO clinical research software platform.
“Not only was it [TEMPO] affordable, they were willing to offer flexibility no one else could match,” John said. “Trials are expensive, and they understood our needs.” Perhaps most compelling for On-X, Clinipace also offers flexible implementation options.
As part of the evaluation process, On-X determined that with TEMPO software, they could provide project management themselves – with a team of three internal people – at a total cost savings of 50 to 60 percent—over $2 million—compared to outsourcing alternatives.
“Our original assumptions on cost savings are evident and real as we continue conducting this groundbreaking study,” Ely said. “As a result, we’ve re-invested the savings into further product innovation initiatives,” continues Ely.
“We started the company over four years ago with this result in mind, we knew there was a better, more affordable way to conduct research” said Chris Porter, Chief Operating Officer at Clinipace.
“We have always maintained this mantra, and our mission is to provide customers with the tools and services to complete their research initiatives without the huge expense traditionally associated with CROs and legacy software vendors. We are thrilled that John and his team at On-X are realizing significant savings, and we are taking this same message to the rest of the market,” continues Porter.
The long-term anticoagulation study is currently ongoing and upon completion of this five year study the FDA will determine whether the research conducted by On-X – powered by TEMPO – is conclusive enough to make On-X’s prosthetic heart valve the first ever FDA-approved mechanical heart valve permitted for low-dose anticoagulation therapy. However, until the completion and analysis of study data, On-X Life Technologies continues to recommend standard anticoagulation therapy as presently prescribed by various professional societies for the On-X valve.
Clinipace is a clinical research software company providing a single, integrated data capture and study management platform for post-approval research and registries conducted by biopharmaceutical and medical device companies, Clinical Research Organizations (CROs) and Academic Medical Centers (AMCs). Our platform, called Tempo, is delivered via a web-based, on-demand architecture that streamlines the clinical research process by eliminating the integration headaches associated with multiple platforms, reducing project efforts and costs from startup to conclusion, and empowering project stakeholders to make informed real-time decisions regarding their research. For more information on Clinipace, please visit: www.clinipace.com.
About On-X Life Technologies
On-X Life Technologies, Inc. (On-X LTI) develops heart valve replacements that significantly improve the quality of life for patients. The On-X valve design was awarded a 2002 Medical Device Excellence Award in the Implant and Tissue-Replacement Products category. On-X LTI also provides OEM services utilizing its patented On-X carbon to manufacturers of other medical products, including orthopedic joint and spine implant devices. MCRI, now On-X Life Technologies, was founded in 1994 by a team of heart valve material and design scientists and engineers lead by pioneer Jack Bokros, PhD. Capitalizing on more than 30 years of heart valve design experience the team developed and continues to manufacture the On-X Prosthetic Heart Valve. The valve is approved for use within the US and throughout the world. On-X LTI is headquartered in Austin, Texas, and maintains wholly owned subsidiaries, MCRI Inc. and MCRI Deutschland GmbH, in Hannover, Germany. More information is located at www.onxvalves.com and www.heartvalvechoice.com.
MCRI™, On-X® Prosthetic Heart Valve and On-X® carbon are trademarks of On-X LTI, registered in the US Patent and Trademark Office and corresponding foreign filings. All other trademarks mentioned herein belong to their respective companies.