On-X Life Technologies Significantly Reduces Study Management Costs with TEMPO from ...( On-X saves ove...),Health

On-X saves over $2 million in conducting the company's prosthetic heart valve clinical trials - a phase IV and safety registry - with Clinipace's TEMPO research platform

Research Triangle Park, NC (PRWEB) July 31, 2008 -- 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 conducing 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
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