Clinical Trial Supplies

Lifecycle management involves clinical supply management from bulk buying through reconciliation and destruction and also vendor management. Clinical product packaging, labeling and product design efficiently navigates challenging local import and export regulations for on-site delivery of investigational products and supplies. International Conference on Harmonisation (ICH)- and Good Manufacturing Practice (GMP)-certified contract warehouses can be found in any major country. As biopharmaceutical companies expand their operations, the various components of the trial see variations as per the local regulations and infrastructure. One of the key drivers of a safe clinical trial is the supply chain management for the drug that is being administered. Given that factors like temperature sensitivity, regulatory compliance, safety and security of the drug has huge impacts on timelines and costs of a study, sponsors and CROs have realized the need to focus on Clinical Trial Supply Management. In addition to the Investigational Medicinal Products and other study related drugs, clinical trials require a host of other supplies, including but not limited to diagnostic, testing and medical equipment, centrifuges, disposable products, refrigerators, computers, eDiaries and ECG machines. As a fundamental imperative of trial recording, each site must be supplied with various trial documents, including site reference manuals, investigator literature, Case Report Forms (CRFs), and trial procedures. Due to the rise in complexity of many trials, the quantity of ancillary supplies and the number of diverse vendors needed to produce them has increased significantly. The difficulty in ensuring that essential supplies reach sites in a cost-efficient manner for global studies is even further amplified. Clinical Trial Supplies & Logistics services include QP release and EU Gateway services, Customs process management worldwide, faster set-up, Reduction in costly drug overproduction and overstock, packaging design, demand/clinical forecasting supply strategies, clinical packaging and distribution to sites. Some of the CRO’s also offer clinical trial services like Assistance with Clinical Trial Authorisation applications, Label and carton creation, Randomisation & blinding, QP Declaration of GMP compliance for IMPs sourced from outside the EU, involving manufacturer site audits, Sourcing licensed and unlicensed medicines to be used as IMPs, NIMPs, Comparators, Manufacture of products (over encapsulation, matched placebo and bespoke IMP and placebos in a variety of pharmaceutical forms), Investigational Medicinal Product Dossier (IMPD), QP Release Certification, Primary product packaging, Secondary product packaging, Storage (ambient, cold-chain and Controlled Drug), Distribution of products, Returns and destruction of products from trial sites, Matching placebos etc End to end clinical trial material supply chain capabilities include supply strategy, forecasting 7 simulation, clinical manufacturing, packaging & labelling, site management, lab sample procurement and management.