Many pivotal studies rely on local laboratory data for their endpoints, either as standalone lab data or in conjunction with central laboratory data. But what limitations do local laboratory data have in terms of quality and variability? And how easy or difficult is it to collect them? This audio conference presentation provides comparisons between central and local laboratory data in terms of quality and combinability, and gives attendees valuable insight into choosing the right design for their clinical trials.

This audio conference covers:

• Local laboratory use as design parameter in a pivotal study
• Variability of local laboratory data vs. central laboratory data
• Cost in methods of capturing local laboratory data
• Common examples of studies where local laboratories need to be used
• Implications for study sites when local laboratories are used

About the speaker:

Jaap Dijkman holds an MD and an MBA degree from Erasmus University, Rotterdam, the Netherlands. He started his career in the pharmaceutical industry with Merck Inc. and Yamanouchi (Astellas). In 1992 Jaap joined the CRO business as European Operations Director at SB Clinlabs (Quest). In 1995 he started Virtual Central Laboratory, which was then sold to Covance in 2002. Jaap held various managerial roles at Covance until he joined Medial in March 2010. At Medial, Jaap is responsible for a diagnostic lab business with around €25M annual revenue and 380 employees.

Who should attend?

• Study Directors
• CRAs
• Clinical Trial Leaders
• Project Managers
• Medical Directors
• Business Development