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Shortly
after you select ICON Central Laboratories for your study, your
Project Manager and Setup Specialist will begin working with you
and members of your study team to complete the Central Laboratory
Worksheet (CLW) for your study. The CLW is an important tool in
guiding and documenting preferences regarding custom reporting requirements
and investigator site support. This information is very important
and will drive the timeline associated with establishing the study
database structure, preparing the custom investigator manual, presenting
at your investigator meeting and other tasks related to managing
the laboratory component of your study. As a general rule, we require
six (6) weeks from the time the contract is signed until study supplies
are shipped to investigator sites. However, we work with sponsors
whenever possible to meet the required timeframes for the study. |
The Challenge: One of the
industry's largest pharmaceutical companies contacted ICON Central
Laboratories after the central laboratory with whom they had originally
contracted failed to meet the service levels needed for a 5000 subject
Hepatitis C trial. With one sixth of the subjects already enrolled,
our Project Management staff knew that special attention would need
to be given to ensure a smooth transition.
The Solution: Working closely
with the study sponsor to establish special internal procedures
to support investigator sites and protect the integrity of the laboratory
database, we were able to meet every challenge associated with the
"rescue" of this important clinical trial. As a result,
ICON Central Laboratories has earned trust of this valuable client
and serves as the laboratory of choice for numerous follow-up studies
in their clinical development program. |
