The Clinical Trial Supply chain: Best practice to ensure ... - Almac

More documents

Recommendations

Info

overage, therefore adding to the trial cost and lead times for production. Study monitors can provide inventory verification but this approach can lead to a fragmented approach if multiple supply campaigns are required. Use of Interactive Voice Response Systems (IVRS) Traditionally both IVR, and similar web based systems have been the scope of large Phase III trials, with complex dosing and inventory requirements. However the quality of reporting tools available and management of randomisation has encouraged increased use within the industry. An IVRS provides full visibility of released finished patient kits held in Sponsor, or third party depots, and also at the study sites. During study set up, it is usually decided to supply sites either by using defined stock levels that are resupplied based on various set trigger points, or by a just-in time delivery (for each patient visit) depending on the best fit for the study. Ultimately, this can assist the clinical trial supply chain in not only presenting alerts for low stock levels at sites, but also in country or central depots such as a contract packager/distributor. The ability to manage the supply chain at site, country depot and central depot allows the trial medication to be managed more effectively, and can assist in the overall supply chain. Again, lead times for all components (such as bulk drug) and production of supplied kits, means that careful monitoring of this interface is required. It has already been possible by agreeing common data set protocols to permit data interchange between IVR and distributor systems to facilitate electronic ordering of patient supplies. Although not full integration, it does at least serve to enhance reporting, visibility and ordering efficiency, especially when integrated with bar coding of the clinical supplies. By utilising a vendor with both distribution and IVR expertise, the trial supply can be integrated with input on streamlining trial set up and management of drug inventory. Forecasting programs Programs are available that can simulate different trial supply scenarios and model the affect of using differing variables in terms of patient recruitment levels, the quantity of site shipments and multiple site supply strategies. In combination with IVR or in isolation, these can be effectively used upfront to help decide on actual site supply strategies. Forecasting can also be used to estimate how long quantities of supplies will last for. This can be particularly useful when the study has commenced and forecasts need to be made covering the entire supply chain for resupply of study kits.
Electronic Data Capture (EDC) systems in the supply chain Although primarily for quality data collection, certain data sets within EDC systems can be used by distributors to predict an efficient just-in time drug supply, again helping effective monitoring of inventory and reduction in waste drug. By using patient enrolment information and also establishing specific dispensing visit timetables, inventory can be managed between a distributor and EDC system. In our experience, this approach can work well for trials with simple dispensation rules and minimum dosing scenarios. Future solutions Several companies involved in outsourcing have attempted successfully the process of data integration on specific parts of the supply chain. However the main issue remains that with so many differing in–house systems and services provided by third parties that solutions tend to be point to point. As a result Sponsor companies that use a suite of tools to manage the clinical trial supply chain face multiple areas of data integration. Each of these requires programming, testing and validation for each source in the chain. Likewise, the vendors also will have this problem for each Sponsor Company they are involved with. Standardised data transfer? Organisations such as CDISC (www.cdisc.org) are working to establish guidelines for data transfer standards, which could provide a platform for future integrations. Also file transfer protocols, such as XML, offer enhanced possibilities for data transfer. Data portals that allow multiple sources to “speak” using an integration layer present an opportunity for automated data sharing between companies, therefore feeding data from site, depot and the manufacturing facility to allow tighter supply chain integration.
Page 1 and 2: The Clinical Trial Supply chain: Be
Page 3: Approaches to clinical trial supply

The Clinical Trial Supply chain: Best practice to ensure ... - Almac

Create successful ePaper yourself

Delete template?

Save as template?