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To manage CTM or IMP and guarantee that a sufficient amount of clinical supplies will be available when required, it is important to have tools and techniques.
FREMONT, CA: A company can be big or small, but clinical studies are an essential part of drug development. However, with times the amount of registered clinical studies is increasing all over the world. Every clinical trial must make sure that enough supplies are there for studying drugs at the study sites. Here are five primary tools and techniques that are necessary for effective planning, monitoring, execution, and inventory control of the clinical trial material (CTM) from the perspective of manufacturing, packaging, and distribution. Furthermore, the pillars of the clinical supply chain management are a project plan or tracking tool, a distribution schedule, a production forecast, a re-supply plan, and a risk mitigation register. It is possible to build the designs in an Excel workbook or maintain the software system that aims to support manufacturing, control (CMC) or clinical material supply chain, and chemistry.
It can be a challenge to decide about the time needs of re-supply. At times the CTM or the investigational medicinal product (IMP) is packed and labeled, and then there might be situations where there can be a requirement of a campaigned approach to fulfill the needs of the study. However, to properly plan work after the first campaign, it is vital to have a device that can predict the requirement of the patients so that there is enough time to arrange the supplies needed for distribution. The re-supply and initial supplies are developed from the distribution plan, lead times through the significant units of operation, current inventory quantities, the expected use-by or expiry of the CTM/IMP, and demand inventory. There can be many software tools to complete the tasks, but Excel has the essential functions necessary to generate and update the plans.
If there is no clinical forecast, then it is crucial to create a production forecast from which plans can be developed for API, third-part resources, excipients, and packaging components. The forecast is like a tool from which the doctors can plan about the necessary operations so that they can support one several studies altogether. The forecast can also be used as an instrument for the external and internal stakeholders because every party needs to agree about the present and future positions of the inventory. Hence, if there is no forecast, then everything around CTM becomes reactive or rather inactive. The forecast offers a basis for the reaction because it is necessary for the changing environment of the clinical settings.
When the clinical strategies of the company are well-defined, they can update the forecast and its detail that contains a consideration of program or study-specific lead times, country-specific challenges, and kit designs. The operational assumptions are associated with packaging, manufacturing, and even distribution of the test articles. According to CMC, an efficient forecast can be generated, knowing the amount of medicine that has to be produced for a treatment.
Project Plan or Tracking Tool
In the case of studies, it is crucial to have a plan or a project file for a successful supply. The project consists of every pre and post-production activity that needs to deliver the supplies to the sites. However, during most of the cases, a project management tool like the tracking tool or the project plan can be used, and the modification can be done based upon the requirement of the study. As a template, the devices can be useful as it can assist in socializing and bringing aid to other departments so that they can understand the drivers of GMP-compliant CTM.
Although the project plan might need many calculated activities, it can also include a strategic element in it. The method also implements information for the present and planned studies so that it can make sure that the clinical supply, procurement, clinical demand, and manufacturing are all united. Moreover, the result of complete plans and the act of strategic plans are significant and useful if it happens on a regular basis so that it can be operational among the company’s culture.
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