|
When pharmaceutical and biotechnology
companies conduct clinical trials in oncology, infectious
disease and other therapeutic areas involving more acutely
ill study subjects, they often face special challenges. How
can the trial sponsor use the local laboratory testing necessary
to provide the appropriate level of medical monitoring, streamline
case report form completion at the investigator site and simultaneously
integrate laboratory result data from multiple sources into
a single study database?
At ICON Central Laboratories
we understand that our role as your central laboratory takes
on new meaning when you are faced with these issues. That’s
why we have established our Technical Services Group. This
special team works closely with your project staff to develop
and implement a study-specific plan to receive and manage
locally performed laboratory test results and make them readily
available to study monitors and data managers.
Although this service does not
require ICON Central Laboratories to perform testing, it does
require significant rigor with respect to planning for, receiving,
entering and performing quality assurance checks on test information
(often provided in many languages) so that one accurate test
result database can be generated for the client.
The special procedures and quality
control features utilized for this service include:
- A "test" transmission
from each new study site to verify site personnel’s
understanding of procedures and ensure proper functioning
of the fax transmission system between the site and ICON
Central Laboratories;
- A consistency check of study
and subject demographic data upon receipt of each faxed
report;
- Affixing an ICON Central
Laboratories bar code label to all local laboratory reports
for tracking purposes;
- Close review to detect any
unusual values and ensure proper language translation;
- Verifying questionable or
incomplete results with the performing laboratory prior
to entry and release of results to the database;
- Use of a double data entry
system to ensure accuracy;
- Transcription of relevant
comments provided by the performing laboratory into the
database;
- A complete audit trail of
entries and changes;
- Secure, systematic archival
of all laboratory and site transmission documents.
These services are supported
by dedicated computer equipment, fax modems and toll free
fax numbers to expedite data processing and communications
with investigator sites worldwide.
For more information about how
ICON Central Laboratories can assist you in managing local
laboratory test results, please contact us at:
icon-ts@iconlabinc.com. |
The Challenge: An
oncology study required the use of over 40 local laboratories
worldwide to ensure appropriate medical monitoring of study
subjects. The study sponsor asked ICON Central Labs to find
a way to expedite the management and compilation of local
laboratory results to expedite data analysis.
The Solution: ICON
Central Laboratories solved this client’s challenge
by using its proprietary Protocol Administration Computer
System (PACS) to capture, manage and compile local laboratory
data. In addition, we found a way to streamline documentation
procedures at the investigator sites by having sites use toll-free
fax lines to send copies of the local laboratory result report,
eliminating the need to complete the lab portion of the CRF.
We also developed special procedures to handle the translation
of test information provided from over 33 countries and set
up rigorous review and data entry procedures to ensure accuracy
and completeness. The result for our client – a single
test result database for the study that the sponsor’s
data management staff and biostatisticians could utilize with
to complete its FDA submission.
|
