The ultimate outcome of our central laboratory service is the incorporation of laboratory data into the sponsor’s study database. ICON Central Laboratories has made a significant commitment to its IT and Global Data Services Departments with regard to both staff and technology.

Strong working relationships between our Global Data Services and each sponsor’s data group are key to ensuring successful data transfers. For this reason, ICON Central Laboratories assigns a primary Data Services Coordinator to work closely with each sponsor. Each Data Services Coordinator works directly with the sponsor during the setup phase of the clinical study to ensure that all data are appropriately captured in the database and meet the formatting specifications of the client.

Protocol Administration Computer System (PACS)

The foundation of ICON Central Laboratories’ Global Data Services is our proprietary Protocol Administration Computer System (PACS). All of ICON Central Laboratories’ locations, worldwide, are connected to this system, enabling clients to receive one unified database while continuing to benefit from flexible system features that support regional differences, such as reporting in both conventional and standard international units (SI).

PACS uses bar code technology. This unique bar code system facilitates our laboratories’ commitment to clean, validated data in a format that can be turned around quickly to the sponsor. Some features and functions of our dedicated PACS system include:

• Proprietary software designed specifically to manage clinical trials for a central laboratory;
• Operational since 1995 – upgraded and validated continuously since its inception;
• Primary tool for study set-up and tracking;
• Fully integrated with all core functions, including kit building, results reporting, sample storage and data exports
• 21 CFR Part 11 validated;
• Details protocol information;
• Creates and dispatches kits to sites;
• Receives samples into laboratory and storage system;
• Ensures "data cleanliness"; automatically faxes laboratory reports and produces hard copies;
• Produces management reports for study tracking;
• Manages a variety of "call lists";
• Exports data electronically;
• Other functions, sample storage and billing.

System Security and Disaster Recovery Capabilities

Our IT Operations Data Center, located in our Farmingdale, NY headquarters, has been designed to offer the most up-to-date capabilities in infrastructure, security and disaster recovery technology. The new system utilizes fiber optics, REES™ monitoring, FM200™ waterless fire suppression and power backup from an on-line UPS power source and two backup diesel generators.

Our offsite data backup procedures include daily pickup of a data tape by Vital Records, Inc. This company’s services include GPS tracked transport vans and data storage in a facility in New Jersey that was previously used as a high-level security bunker for U.S. presidents in the event of a national emergency.

ICOLabs Remote Data Access Tool

ICON Central Laboratories offers clients ICOLabs™, a fully validated, secure, web-based remote data access tool that offers:

• Comprehensive filtering criteria using drop-down menus;
• Custom views and reports that can be generated and saved by the user to meet study management, clinical safety or site monitoring needs;
• Study and subject trend reports that include both numeric and graphic displays;
• A menu of standard reports, based upon input from clients;
• Ready access to each study subject’s visit-specific laboratory report;
• Easily accessible investigator contact information for streamlined follow-up with sites;
• Kit inventory reports to better track supply levels at investigator sites;
• Frozen specimen reports that track storage and shipping status;
• Ability to save and export reports in Excel formats.

ICOLabs™ is fully supported by ICON Central Laboratories’ Remote Data Access (RDA) Department.