Saving more than $2 million in conducting the company’s prosthetic heart valve clinical trials, On-X Life Technologies has worked with Clinipace, an on-demand clinical research software company when conducting two research studies using TEMPO – Clinipace’s software platform.

 

The company originally pursued an outsource management strategy because of the perceived complexity of the project. Also, the randomized control clinical trial involves up to 1,200 patients across 40 different medical centers nationwide. On-X Technologies decided to take a different path to reduce cost and manage the study internally with On-X employees and clinical research software, after several weeks of cost analysis and market research.

 

On-X started the process of evaluating partners to assist with study management after it received the U.S. Food and Drug Administration (FDA) approval in early 2006. With this, the company was granted permission 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 determined that with TEMPO software, they could provide project management themselves as part of the evaluation process. Compared to outsourcing alternatives, this came at a cost savings of 50 to 60 percent over $2 million and with a team of three internal people. Clinipace always looks to offer customers with the tools and services to complete their research initiatives. The company seeks to achieve this by avoiding huge expense traditionally associated with CROs and legacy software vendors.

 

After the completion of this long-term anticoagulation 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.

 

“We had to find the right software partner to work with us,” John Ely, executive vice president for Regulatory Affairs at On-X Technologies 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. We had to find the right software partner to work with us. 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.”