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 providi
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