ABSTRACT
Major pharmaceutical players strive to bring their next breakthrough medicinal product to the marketplace, ever conscious of the development costs involved. However, the hurdles to proving safety and efficacy present a formidable challenge, not least because of the numbers of patients involved in clinical trials. Medical statisticians may insist on matching placebos, proper randomization, and double blinding, while regulatory agencies expect high-quality standards for trial materials. Supplies of clinical trial medication can, therefore, become a critical factor in determining the successful outcome of a trial. The special skills needed to produce clinical trial supplies (CTS) add an extra dimension to the complex business of clinical research. The role of a contractor in providing clinical trial supplies services is increasingly important in the area of clinical development. Here, we look at the complex business of clinical trial supplies and how contractors are responding to the challenge of meeting a growing demand for outsourcing the essential test articles that are the very focus of clinical research trials.
