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Lab Profile : Global CRO
Laboratory Profile - Global CRO
Quick Summary
| Laboratory: |
ICON Central
Laboratories |
| Lab Contact: |
Carol Rosenthal
Director of Research and Development |
| Patient Testing: |
ICON supports 545
active studies with their clinical trial work. |
| Cytometers: |
BD FACSCaliburs and
BD FACSCantos II
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| Laboratories: |
Locations in New
York, Dublin, India, and Singapore |
| Testing Menu: |
T & B Cell
analysis, immunophenotyping, activation markers, saturation assays,
apoptosis, cell signaling, custom assays |
| Prior Analysis
Software: |
BD Cell
Quest |
| Major Concerns: |
Global Company with
Multiple Locations, Standardization |
Laboratory Overview
ICON Central
Laboratories is a global facility whose sole purpose is to provide
excellent
central laboratory and related support services to pharmaceutical and
biotechnology companies engaged in clinical trials.
ICON's in-house testing menu offers more than 450 tests which includes
the routine safety and efficacy testing required for trials as
well
as providing support for technology transfers and the development of
specialized assays. Additionally, they also provide a number
of
more esoteric types of testing such as flow cytometry based
assays.
ICON started out providing cytometry results in 1998 with the New York
and Dublin laboratory locations offering only CD4 / CD8 testing.
The flow menu and number of labs has since expanded; with
multiple locations doing
more support flow research and monitoring therapies as well as oncology
based assays. ICON labs responded to the increasing global
clinical trial demand by expansion in other countries such as India and
Singapore.
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Lab Concerns
Expanding and becoming a Global facility introduced a number of
concerns for ICON Labs. Since the new lab locations were in
different continents, they
needed to find a better way to handle and share their FACS data; they
needed to develop a means of standardization; to incorporate better
quality control
measures between the sites; and they had to find a solution to overcome
the various time differences between locations. Basically
each site needed to operate as part of a single entity
regardless
of where
they were actually located in the world. Each lab
needed to
be able to analyze the data and produce the same results.
Then
they needed to be able to share those results both quickly and
accurately.
By selecting labs utilizing similar protocols and
instrument platforms as ICON, Carol
Rosenthal hoped to minimize efforts towards standardization.
These
labs were using Cell Quest software from their BD FACSCaliburs to
analyze their cases. Results were shared by faxing
reports between locations which was not only time
consuming but did not allow for re-gating or any other adjustments to
the results. The labs were also performing their data
analysis on the
computers running the flow instruments reducing the
amount of time spent acquiring additional cases. There was no
easy way to standardize the analysis templates or SOPs used by the
various locations and no good way to deal with the different time
zones encountered.
Benefits of FCS Express
Carol met David
Novo at
one
of the Clinical Cytometry Meetings. She had seen data from
FCS
Express displayed during the annual Flow Cytometry course and decided
to find out more about the program's features. She downloaded
the free 30 day FCS Express demo and tried out the program for herself.
Carol found FCS Express easy to learn and
enjoyed using the off-line compensation and batch analysis functions.
A key advantage to FCS Express
was the availability of the FCS Express Clinical Edition,
which registered with
the FDA for in-vitro diagnostic (IVD) testing. The Logging
(Audit Trails), Security and
21 CFR Part 11 compliance features were a necessity for the type
of work her facility performs. Having data analysis that was
specifically designed for clinical use eliminated many of the
regulatory hurdles she had to overcome with the other software
packages, which are designed primarily for research use. She found that
FCS Express
provided other advantages as well for the ICON
locations. By performing
off-line data analysis with FCS Express the labs showed increased
productivity,
freeing up the instruments for more data acquisition.
Standardization was finally possible by using the same
analysis templates at each location allowing for consistent gating and
results.
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The team at De Novo Software worked with Carol to set up a global
system to support her various lab locations. It was decided
that
the analysis templates would be developed in the New York location
along with written procedures and
policies. When a new assay is ready to go into production,
the
template and procedure is placed on a server in New York. De Novo
Software incorporated special functionality into FCS Express to allow
the various labs around the world to access the layouts in New
York as simply as if the layouts were on their local hard drives. With
the
21 CFR Part 11 Security functionality, templates can be locked
down so the technicians
performing analysis can not change the gating strategy, they can merely
adjust the gates that already exist. At each site, the
FACSCaliburs acquire data and save it to the server. The data is then
analyzed locally on an off-line PC. Once the analysis has been
completed, the technicians simply press a button in FCS
Express,
and the data and analysis is automatically sent to the ICON Central
Labs main
servers in New York. Once the data is at the New York site, the
supervisors review the analysis and once they approve it, the
data is sent directly from FCS Express to the ICON LIS system
which provides better
availability for ICON's various clients when requested. The
multiple sites can communicate via web conferencing and
emails allowing the virtual facility to operate in real time.
Future plans include the addition of FCS Express Publishing
functionality which will allow clients to access their listmode files
and data by logging into their secure account from their own computers.
Carol Rosenthal said: "When we first started this project, it was very
daunting. De Novo Software was going to have to modify FCS Express to
interface with three different computer systems within ICON Labs. Some
of the systems were very old, and had very complicated and difficult
requirements. Plus, they were going to have to be able to do this from
software running in remote locations around the world.
However,
the project went far more smoothly than expected. Since De Novo
Software has extensive expertise in biology, flow cytometry and
computer science they were able to speak with all facets of our
organization to help facilitate a successful project. In fact, they
often acted as 'translators' between our flow cytometry and IT staff to
help overcome the conceptual misunderstandings that often arises
between such separate disciplines. They suggested many different
workflow processes that would meet the requirements of both the flow
cytometry and IT departments. De Novo Software delivered their
modifications on time and on budget which is a rarity in our business."
Carol concludes that ICON Central Labs just couldn't do what they do
without
bringing in FCS Express. She briefly lists some of the benefits that
have
saved them both time and money as follows - "greater throughput and
increased efficiency with off line analysis,
global functionality increased our client base,
performing calculations for MESF conversions in the analysis
layouts saves time, the QC process is more stringent by using
tokens to extract statistics and patient information, off line
compensation reduces repeats. All these things mean a lot
when dealing with as many instruments and labs as we do.
Nonetheless, it doesn't matter how good a product is without good
support.
Our labs are running 24 hours a day, and resolving problems
immediately is crucial for our
operation to be successful. Everyone at De Novo have
been great. Their response has been wonderful."
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