Mr. John Ely

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  www.prweb.com/releases/2008/7/prweb1162034.htm - [Cached Version]
  Published on: 8/5/2008    Last Visited: 8/5/2008  

  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 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.

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  www.mcritx.com/mgmt.htm - [Cached Version]
  Published on: 3/20/2007    Last Visited: 3/20/2007  

  John ElyExecutive Vice President Regulatory AffairsGovernment/Industrial Relations

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  Clinipace Chosen by Medical Carbon Research Institute... - [Cached Version]
  Published on: 3/29/2006    Last Visited: 3/29/2006  

  "These post-market anticoagulation trials are a critical element in determining the future of our On-X valve," explains John Ely, Executive Vice President of MCRI."We chose Clinipace for the job because their proven web-based solution will allow us to collect and manage intricate data from several sources more simply, and cost-effectively than other vendors."
  
  Mr. Ely goes on to explain the desire to reduce the administration burden often associated with these kinds of studies, "Our current research sites are already dealing with a complex study protocol, couple that with the coordination that goes into managing several data sources and you can end up depleting your internal resources with the administration of the trial.

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  MCRI Granted FDA Approval to Conduct Reduced... - [Cached Version]
  Published on: 1/10/2006    Last Visited: 1/10/2006  

  Interested parties should contact John Ely, Executive Vice President of Regulatory and Clinical Affairs for MCRI, at 888-339-8000, ext. 226 or ely@mcritx.com.Information and updates for this and other On-X Prosthetic Heart Valve studies are located at www.onxvalves.com or by contacting MCRI.

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  Medbizpeople.com - Job Center - [Cached Version]
  Published on: 5/30/2001    Last Visited: 12/15/2001  

  "The On-X valve has remarkable clinical performance," said John Ely, MCRI Vice President of Clinical and Regulatory Affairs."The On-X valve sets `The New Standard(TM)': the hemodynamics are superior and the smooth blood flow results in minimal blood damage and low complication rates, which provide maximal benefit and restored quality of life for patients.With the success of today's techniques for mitral valve repair, mitral valves are replaced less often than in the past.Therefore, more time has been required to attain the needed clinical experience for mitral valves.Needed additional follow-up is nearly complete and premarket approval for the mitral valve should follow quickly."

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  Medical Office Software Inventory - [Cached Version]
  Published on: 3/4/2005    Last Visited: 7/2/2006  

  John Ely is MCRI's executive VP for regulatory affairs.

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  ON-X Valves - A Product of MCRI - [Cached Version]
  Published on: 8/22/2006    Last Visited: 12/14/2007  

  Interested parties should contact John Ely, Executive Vice President of Regulatory and Clinical Affairs for MCRI, at 888-339-8000 ext. 226 or ely@mcritx.com.Information and updates for this and other On-X Prosthetic Heart Valve studies are located at www.mcritx.com or by contacting MCRI.

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  ON-X Valves - A Product of MCRI - [Cached Version]
  Published on: 7/9/2006    Last Visited: 12/14/2007  

  Interested parties should contact John Ely, Executive Vice President of Regulatory and Clinical Affairs for MCRI, at 888-339-8000 ext. 226 or ely@mcritx.com.Information and updates for this and other On-X Prosthetic Heart Valve studies are located at www.onxvalves.com or by contacting MCRI.

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  ON-X Valves - A Product of MCRI - [Cached Version]
  Published on: 6/25/2003    Last Visited: 12/14/2007  

  The study protocol has received European ethics committee approval," remarked John Ely, MCRI's Executive Vice President Regulatory Affairs.

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  On-X Life Technologies Significantly Reduces Study... - [Cached Version]
  Published on: 7/31/2008    Last Visited: 1/2/2009  

  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 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.

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