The Virtual Central Laboratory approach for the retrieval and management of clinical laboratory data for clinical studies

In 1996, the Virtual Central Laboratory (VCL) concept was presented at the 2nd Conference on Quality [R]evolution in Clinical Laboratories: participating laboratories measure calibrators. The outcome of these measurements is used to calculate conversion factors. The obtained factors are subsequently applied to standardize the results of a number of routine chemistry parameters. This conversion method is now part of a quality system to collect clinical laboratory data in accordance with the Good Clinical Practice guidelines on patients participating in clinical trials organized by the pharmaceutical industry. This approach eliminates the need for centralized laboratory services. Presently over 300 laboratories participate in a number of pan-European clinical trials where the VCL is applied. In this paper our experiences over the last 2?years will be discussed.