Navigation Links
On-X Life Technologies Significantly Reduces Study Management Costs with TEMPO from Clinipace
Date:7/31/2008

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," 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.

About Clinipace:
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.

###

Read the full story at http://www.prweb.com/releases/2008/07/prweb1162034.htm


'/>"/>
Source: PRWeb
Copyright©2008 Vocus, Inc.
All rights reserved

Related medicine news :

1. Planet Technologies Announces Agreement to Acquire Antigen Laboratories
2. Cardiovascular Technologies to be Highlighted at 5th Annual Cleveland Clinic Medical Innovation Summit, Oct. 1-3
3. VNUS Medical Technologies Announces Resignation of Chief Financial Officer and VP, Finance & Administration
4. Osteotech to Present at First Albany Capitals Regenerative Technologies Conference in New York
5. ReBuilder Medical Technologies, Inc. Reports International Sales Expansion
6. Advanced technologies aim to transform the coaching of top athletes
7. Global Med Technologies(R) Extends Its Worldwide Outreach
8. Acuo Technologies(R) Names Mike Dolan Vice President of Sales
9. ReBuilder Medical Technologies, Inc. Signs Agreement for Distribution in Maine
10. Neurobiological Technologies Reports Going Concern Qualification
11. MedCom USAs Subsidiary Card Activation Technologies, Inc.s SB2 Registration Declared Effective by SEC
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/26/2016)... Aliso Viejo, California (PRWEB) , ... June 26, 2016 , ... ... for Final Cut Pro X. , "Film editors can give their videos a whole ... artistically," said Christina Austin - CEO of Pixel Film Studios. , ProSlice Levels ...
(Date:6/26/2016)... Orion, Clarkston, Michigan (PRWEB) , ... June 26, ... ... with respect to fertility once they have been diagnosed with endometriosis. These women ... intercourse but they also require a comprehensive approach that can help for preservation ...
(Date:6/25/2016)... ... , ... The temporary closing of Bruton Memorial Library on June 21 due to a possible ... often overlooked aspect of head lice: the parasite’s ability to live away from a human ... but a necessary one in the event that lice have simply gotten out of control. ...
(Date:6/25/2016)... ... June 25, 2016 , ... As a lifelong Southern ... Laude and his M.D from the David Geffen School of Medicine at UCLA. He ... Los Angeles to complete his fellowship in hematology/oncology at the UCLA-Olive View-Cedars Sinai program ...
(Date:6/25/2016)... ... , ... Conventional wisdom preaches the benefits of moderation, whether it’s a matter ... bar too high can result in disappointment, perhaps even self-loathing. However, those who set ... , Research from PsychTests.com reveals that behind the tendency to set low ...
Breaking Medicine News(10 mins):
(Date:6/24/2016)... 24, 2016  Collagen Matrix, Inc., ("Collagen Matrix") ... manufacturing of collagen and mineral based medical devices ... Bill Messer has joined the company ... leverage the growing portfolio of oral surgery, neurosurgery, ... Bill joins the Collagen Matrix executive team as ...
(Date:6/24/2016)... , June 24, 2016   Bay ... Rehabilitation Network,s Dean Center for Tick Borne ... Medicine and Rehabilitation, MIT Hacking Medicine, University of ... Innovation, today announced the five finalists of ... Lyme disease.  More than 100 scientists, clinicians, researchers, ...
(Date:6/24/2016)... , June 24, 2016 ... of the "Structural Electronics 2015-2025: Applications, Technologies, ... In-Mold Electronics, Smart Skin, ... Photovoltaics Structural electronics involves electronic ... load-bearing, protective structures, replacing dumb structures such as ...
Breaking Medicine Technology: