During the lifecycle of an Investigator Initiated Trial (IIT) it’s important to continuously monitor the end-to-end clinical supply chain. The protocol can change in the middle of the study. When that happens, the team needs to be prepared to make changes to labels, depots, forecasting etc. in a timely manner so the patient treatment is not disrupted.
This level of detailed oversight is often beyond the capacity of most pharmaceutical manufacturers. Outsourcing may be a viable strategy so that internal resources can be used in support of company-sponsored trials. Whether managed in-house or via an external provider, it’s important to address these critical steps:
- Establish a single point of contact for all supply chain needs
Maintaining separate contacts for packaging, distribution etc. can introduce delays and opportunities for miscommunication. A single point of contact will streamline the process.
- Provide and accept input during protocol development
Full transparency and engagement with key stakeholders during protocol development can help avoid future amendments that impact the supply chain. Establish a regular review process that covers all new trials and protocols so that the required storage and distribution plans can be properly scoped and deployed.
- Create the packaging and label design/translations at the beginning of the study
There is great value in a consistent approach. Examine requirements across all protocols, and define the best strategy for packaging based on the dosing used for each study. Try to establish a design that fits every study for both the drug and its supporting components e.g. foam, inserts as this translates into cost savings.
The same approach applies to label design. Is it possible to use a generic label that doesn’t use the protocol / sponsor name on label? Is it possible to pool supplies for multiple IITs in one program, or pool supplies for a given country? This strategy makes it easier to forecast, minimizes waste, and provides cost efficiencies due to larger runs with lower per-unit cost.
- Establish your depots at the beginning of the study
As studies expand into new regions it may be beneficial to expand the depot network accordingly to streamline the supply chain. Define the required network early in the process and make sure they are fully aware of the distribution needs and quality standards. Revisit and update timelines based on the depots that are being used for a given study.
- Be disciplined with your forecasting
Change is inevitable, and nearly every change has the possibility of impacting the clinical supply chain. Forecasts need to be revised based on changing enrollment rates or mid-study protocol changes. To ensure enough product is available for future packaging campaigns, to manage resupply campaigns and expiry dates, it’s critical that updated forecasts be shared frequently, as often as weekly.
- Monitor drug orders
Investigator Initiated Trials are often managed without the benefit of Interactive Response Technology (IRT), in spite of that fact some manufacturers may have over 100 IIT’s that require drug shipments. It’s critical to establish a streamlined process that provides visibility to orders so that the depot and onsite inventory can be managed (including QP release), orders can be expedited as needed, and overall quantities can be tightly controlled to minimize waste.
These steps are certainly not a comprehensive list. Additionally the clinical supply manager must monitor for temperature excursions between depots and investigator sites; they facilitate the return and destruction of unused or expired product and, needless to say, they must manage overall costs and provide budget updates.
Given the complexity of the process which can extend across multiple trials for a given manufacturer, it isn’t unusual that an outsourced provider be engaged to manage the supply chain. For example, our dedicated team of global IIT Clinical Supply Managers currently manage over 250 Investigator Initiated Trials. The experience we gain is leveraged across the entire team so our best practices can be applied in support of our client’s needs.
Over a 4-month period of time a mid-sized pharmaceutical’s portfolio had grown to over 100 Investigator Initiated Studies and several thousand patients. They were experiencingsupply shortages that began to impact patients. Download this case study to learn how they revised their approach in order to eliminate stock outs, minimize wastage while managing expiry dates.