ICON Central Laboratories has supported thousands of study investigators in over 60 countries. From this experience we know that our ability to provide timely, quality test results is highly dependent upon the quality of specimen preparation at the investigator site. We also understand that sites need comprehensive instructional materials, easy-to-use supplies and readily available answers to their questions. At ICON Central Laboratories we work hard to provide such levels of support.

Study-Specific Instructional Materials

As a part of the setup of each new clinical study, our staff members develop a comprehensive, study-specific Lab Manual that provides:

• Step-by-step verbal and pictorial instructions pertaining to:

• An overview of study alert, panic and exclusion values;
• A sample study requisition;
• A sample report form;
• A one-page quick reference for the more experienced study coordinator;
• IATA information describing various specimen classifications;
• Courier contact information;
• Telephone numbers for our Investigator Site Services Department.

The draft of the manual is distributed to the study sponsor for review and approval, prior to distribution to the investigator sites. When requested by the sponsor, ICON Central Laboratories will work with certified translation services to provide these materials in the languages necessary to meet the needs of regional and global trials.

Investigator Meeting Presentations

As a part of our standard service, your ICON Project Manager will attend the investigator meeting for your study and present an overview of the laboratory requirements and procedures for the study, as well as answer any questions that your clinical investigators and study coordinators may have.

Easy-to-Use Collection Kits and Requisitions

ICON Central Laboratories knows that study coordinators and laboratory personnel at our investigator sites are busy people. Consequently, we’ve designed our collection kits and lab requisitions to be very easy to use. Our collection kits are study and visit-specific and contain all of the supplies necessary to prepare the specimens required. Similarly, our lab requisitions are customized for each study and require minimal effort by site personnel to complete. Collection kits display an expiration date, corresponding to the earliest date on which an item in the kit contents expires. As an added convenience to sites, study sponsors may opt to have our laboratories automatically re-supply sites with collection kits, based upon usage and expiration dates.

Multi-Lingual Telephone and Email Support

Our Investigator Site Services Department is staffed six days per week with helpful, friendly staff members who notify sites of alert values, resolve data queries and answer questions pertaining to our central laboratory services. We are pleased to have multi-lingual staff members who can offer support to sites in 19 languages.

We are currently able to provide support to our sites and sponsors in the following languages:

Site Inquiry and Issue Monitoring

Our Investigator Site Services Department tracks calls to and from sites using a customer relations database. This system serves as an important part of our service to sites and sponsors. It is also a key component of our Continuous Process Improvement program. Using this system, we are able to readily review and trend contacts with site personnel. Upon request, we also can provide metrics and reports to sponsors so they can better identify study and site related issues.

Our Web-Based Investigator Site Resource Center

ICON Central Laboratories puts information at the fingertips of study coordinators with our Investigator Site Resource Center that can be accessed through this web site. This unique resource for our investigator sites offers:

• Answers to frequently asked questions;
• Ready access to our couriers’ web sites for package tracking and other shipping information;
• Links to IATA and other relevant information for investigator sites;
• Periodic service updates;
• Contact information for our Investigator Site Services locations.