Efficient supply of investigational medicinal products (IMPs) is key to ensuring patients are dosed on time and clinical trials run efficiently. In addition to the IMP, a wide variety of materials are needed to support a clinical trial, including placebo drug product, comparator drug product and ancillary supplies (e.g. diagnostic tests, medical equipment, consumables, etc.). In early-phase clinical trials, all these materials are typically shipped from different suppliers to the clinical centers. The hospital pharmacy staff then prepares prepare tailor-made patient kits that contain IMP, placebo and/or comparator drug product and the ancillary materials.
In addition to these patient kits, the physician will also receive sample collection kits which contain a customized selection of biological specimen collection tubes (blood, urine, tissue, etc.), aliquoting tubes, needles and various sample collection materials. These sample collection kits are usually prepared at the central laboratory (working under supervision of the clinical research organization) and then dispatched to the clinical centers. Assembly of these kits entails a great deal of customization and requires involvement of the bioanalytical laboratory.
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