A large pharmaceutical company had elected to spin off part of its operation, creating a Contract Research Organization (CRO) specializing in the provision of high-quality clinical immunology services. The new CRO had previously been managing its laboratory operation with the LIMS that was being utilized at the pharmaceutical company. This solution, due to the spin-off, was no longer available nor would it have been capable of supporting the new business paradigm. The CRO would now be serving a variety of pharmaceutical corporations, biotechnology companies, and healthcare / non-profit organizations by delivering quality readouts for the clinical development of vaccines and immunotherapies. In order to support their clients and provide GCLP-compliant immunomonitoring activities to support Phase I to Phase IV vaccine clinical trials, the CRO needed to select and then implement a new Laboratory Information Management System (LIMS).
After engaging with 2 or 3 LIMS vendors, the company proceeded to have a number of generic demonstrations of LIMS solutions. It turned out that these demonstrations had very little to do with how the company operated so were of little value. The company realized that it really did not have a good understanding of its needs and it was being overwhelmed by the pressure exerted by the LIMS vendors’ sales representatives. The company determined that it needed to take a step back, regroup, and get some expert help.