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

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Clinical Supply Inventory Chain BULK IMP Packaging components Label text CENTRAL PACKAGED TRIAL SUPPLY STOCK Site inventory Depot inventory Trial FPI date Resupply – trial running Figure 1- Working back from expected First Patient In (FPI) Date When an overview of all scheduled trial supply requirements is agreed, the planning process can enter into a more detailed phase noting each deliverable component required to produce the supplies for the study start date. Without going into the mechanics of project management, the trial manager will of course balance CTA submissions and approvals, along with country specific requirements, in parallel with the production of the clinical trial supplies and its associated inventory chain. Stock levels and tracking of clinical trial supplies Once the clinical trial supplies are available to start the trial, the tracking and monitoring process can begin to ensure that stock levels of kits are maintained and that the supply to each patient is continuous and uninterrupted. Usually for later phase trials with large patient populations, supplies are delivered in phased campaigns, often due to expiry date limitations or comparator availability. This in turn means that stock levels of the initial supply of kits become absolutely critical to continuous patient supply. Now we enter a crucial phase. After study initiation, monitoring of clinical supply inventory throughout the supply chain is essential in order to monitor study kit usage and available stock levels, ensure the drug is always available for patients, minimise waste medication, alert sites in case of potential supply delays and comply with GMP/ GCP conditions .
Approaches to clinical trial supply management: tips for improvement Monitor stock level data Once a trial starts and recruitment gets into gear, supply stock levels can often start to deplete at a different rate than expected. Add to this the needs of expiry date management and soon supplies can start to dwindle. It is essential that stock level data is monitored throughout the entire supply chain, but due to multiple parties and systems involved this is not a straightforward process. Some large Sponsor companies have inventory and management systems capable of monitoring various portions of the supply chain. When the decision has been made to outsource portions of the supply chain, Sponsor companies can suddenly find a gaping hole in any materials management systems. In many cases, once shipped globally, supplies can disappear totally from the Sponsor’s radar, therefore creating a reliance on unconnected reports from other systems (mostly 3rd party), which require manual manipulation of data to forecast future supply needs and manufacturing requirements. Meet with sponsor companies and vendors It is useful to note that as kit inventory is monitored by whatever means selected by the Clinical Managers, plans must be included to make the information available to each participant in the supply chain. This means that outsourcing partners need to be involved in relevant data exchanges that may affect the availability of additional supplies, and that this involvement occurs in a timely fashion. In our experience, joint meetings involving Sponsor companies and associated vendors prior to study commencement are invaluable. Such meetings can present a platform to examine interface exchanges and possible alternative approaches to the study design. Also, it is possible to have one vendor responsible for multiple areas of the supply chain, therefore enhancing control and reducing management concerns. Supply chain management A variety of different approaches are available for management of the supply chain when the study goes live, but the Trial Supply Manager must link the inventory data back into the complete chain. Examples of inventory management include: The manual approach Many Sponsor companies employ a manual approach to the supply chain. Generally this will mean pre-defining set amounts to ship to each site on activation and then another set amount for further supplies. This can result in reduced visibility of the inventory and provide difficulties if sites take on a different level of activity than predicted. Supplies are usually manufactured/ packaged with at least of 100%
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The Clinical Trial Supply chain: Best practice to ensure ... - Almac

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