|
|
Using
Local Laboratories in Global Clinical Trials
Dr. Jaap Dijkman
General Manager
Covance Virtual Central Laboratory
Purchase
recording - US$199
|
 |
Purchase
recording of this Audio Conference
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
Purchase
Options:
|