FCS Express: 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
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.

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 is listed with the FDA. 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.  

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."