It’s a known fact that the Pandemic Effect of Covid-19 apart from creating the hurdles in Clinical Research has also fetched a possibility to many of the new innovations. Supply Chain Management is one of the majorly effected streams due to pandemic which lead to low stock of the API to pursue the Manufacturing of the IMP for clinical trials.
It’s time to invest additional efforts on strategy development for managing the clinical supply activities in more efficient way. The scope of the supply chain management can be made efficient by creating solutions to the current and anticipated challenges.
As industry is also focused more on ‘Direct-to-Patient’ model, Drug Supply Chain Management has a primary role in this.
Few areas of focus for DSCM include:
- Quality: Quality is of course one of the first and foremost key point that needs to be focused. In DtP the concept basically relies on providing the Right Quantity of Supplies to a Right Subject at the Right Time in Right Condition. This shall enable the progress of the study more effectively. Even though it’s not easy to perform these type of tasks during a pandemic, but can be handled efficiently using newer technologies.
- Cost Effectiveness: The cost and the liability of the labor, logistics, and energy shall increase globally due to the current constraints. Even though the budget of the running project is approved upfront,to run the operations effectively with quality, within the set budget, proper cost control plans should be executed through constant monitoring of the logistics and wastage
- Risk Management: To meet the needs of the subject according to the protocolcriteria proper Risk Management Plans shall be implemented. Whereas for DtP in clinical research, shipping of supplies direct to subjects involves several risks right from shipping to storage to compliance and accountability. Each of these steps need to assessed with proper risk minimization or mitigations plans
- Qualified Resources: DSCM need to focus more on the qualification and training of the staff as DtP is not a simple logistic task. Manpower should be qualified, trained and accountable. They shall be trained and educated more on their responsibilities and action plans to be performed in DtP scenario. While supplying Direct to Patients, teams should develop interaction with the subjects in confirming their demographics, addresses and maintain a good relationship. Should also be trained to collect any return samples left at the subject in order to meet the accountability of the supplies.
- Delay in Delivery: In clinical research the delay in the Treatment Assignment leads to several consequences. Teams should be more cautious in planning the activities related to supplies by anticipating the unforeseen risks that shall lead to delay in supply delivery.
- Adaptation to Needs: It is not easy to adapt to changes but sometimes we cannot abandon the clinical or patent requirements if we need to stand in the race of the research. It is now mandatory to take up the challenge of delivering the supplies direct to patients to withstand the need of the hour.
DSCM should use an effective IRT system that can handle most of these activities to help save time. IRT can help in managing the risks by leveraging automation, supply options, timely alerts and maintain regulatory compliance