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Audio Conference

 

 

Using Local Laboratories in Global Clinical Trials

Dr. Jaap Dijkman
General Manager
Covance Virtual Central Laboratory™

Purchase recording - US$199

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Central laboratories have proven their benefit to pharmaceutical companies in providing high quality data with a single reference interval in clinical trials. But what if your study precludes the use of a central laboratory? For instance, what if result turnaround time limitations do not allow for the use of a central laboratory, but you are still dependent upon high quality laboratory data to evaluate drug safety or efficacy?

When local laboratories are utilized in clinical trials, many different reference intervals are used for the same analytical method. The correlation of this data creates a significant challenge for global product submissions. Using both a central and local laboratory in parallel also presents its challenges due to frequently observed discrepancies between central and local laboratory data, the need for increased blood volume to be collected for duplicate laboratory testing and the bias of investigators towards local laboratory data. This presentation will address these challenges and present a solution to overcome them.

This audio conference will cover:

  • Challenges of using local laboratory data in clinical trials
  • The benefits of a single global reference interval, while collecting data from many different local laboratories
  • The Virtual Central Laboratory approach
  • How the Virtual Central Laboratory model can meet the challenges of local laboratory data collection in global clinical trials

About the speaker:

Based in Zeist, Netherlands, Dr. Jaap Dijkman is the General Manager at Covance Virtual Central Laboratory™. Jaap is responsible for the managing local or regional laboratories outside of Covance's central laboratory service. CVCL collects data from more than 800 laboratories around the world and manages over 20 qualified affiliate laboratories for Covance.

After obtaining his MD and MBA degrees, Jaap joined Merck Inc. in the Netherlands as Product Manager for neurological and ophthalmologic products. In 1989 he moved to Gist-brocades (currently Astellas) as International Product Manager and from there he joined SB-Clinlabs (currently Quest) as European Operations Director. Jaap co-founded Virtual Central Laboratory in 1995 and continued to take responsibility for this operation after it was acquired by Covance in 2002. Since 2002 the company has expanded significantly within Covance and currently employs more than 40 people in locations around the world.

Who should attend?

  • Senior Management
  • Clinical Directors and VPs
  • Global Project Directors
  • Senior Clinical Managers
  • Outsourcing Directors and VPs
  • Outsourcing Managers
  • Feasibility Managers

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