HealthcareClinical Trial Supply Management

Clinical trial supply management refers to the planning, coordination, and delivery of investigational products, including drugs and materials. It covers the entire supply chain from manufacturing to destruction. The aim is to assure that clinical trial participants get the correct treatment and their safety is assured.

Perceptive eClinical’s advanced RTSM is a leading clinical trial solution that helps to ensure effective trial supply management. To date, the solution has been relied upon by global sponsors and trial investigators in over 4,700 clinical trials and over 500 regulatory approved studies.

In this article, we focus on several elements of clinical trial supply management, including techniques for reducing wastage and right-sizing shipments to sites, automation that can ease the workload of trial supply managers, and other methods of streamlining trial management, such as fractional/partial and randomization prediction.

Optimizing site resupply

Ensuring sites are only sent what they need, when they need it, supports trial supply goals and KPIs.

Resource allocation also needs to be considered; when Standard of Care medication is scarce, allocating this medication to clinical trials can deprive patients who need it for routine care.

There are different methods for supporting goals, such as drug wastage, which supply managers should consider.

Perceptive RTSM uses Fractional Prediction to reduce the IMP sent to the site for potential patient titration; this is useful when the quantity or the type of IMP dispensed to patients varies based on trial requirements. The IRT can predict a fraction of each of the possible kits needed for an upcoming visit, thus reducing the overall amount sent to the site.

Medication pooling and just-in-time labelling are other methods of reducing drug wastage and addressing availability or scarcity concerns in trials. It involves sharing to make drugs and materials available for multiple trials, keeping waste to a minimum, reducing costs, and improving efficiency. Leading solutions such as Perceptive eClinical’s RTSM can control medication sharing across different protocols, varying pooling methods according to sponsor requirements.

Automated site resupply strategy management

Without automation, the task of monitoring site stock in line with participant needs places a burden on clinical supply managers and leaves the process more exposed to the potential for human error. An IRT/RTSM will automatically request medication be shipped to sites; the amount is typically based on a predefined, set quantity, with ideally the needs of participants taken into account.

Advanced inventory management can also adapt what’s sent to the site to planned adaptions and time points, for example, when a treatment arm is dropped or when the first participant is approaching a new part of the trial. Automated supply strategy management can also be used to adapt the volume of IMPs shipped to trial sites to the recruitment rate, basing the amount of medication shipped to sites on the number of participants in screening. This is especially beneficial when there is a large number of sites.

Randomization prediction

Randomization in clinical trials is the process of randomly assigning participants to a treatment arm. It ensures that participants are allocated to treatment and control groups without bias and prevents predictability in results, providing a satisfactory statistical basis for evaluating treatment effects.

RTSM systems such as Perceptive eClinical’s solution provide accurate and efficient execution of the randomization of participants to treatment in clinical trials.

Randomization prediction is an advanced inventory management method used by Perceptive eClinical, which reduces wastage by sending IMP to each site specific to upcoming treatment group assignments when randomization codes are dedicated to the site.

Supply simulation

Supply forecasting is key to effective clinical supply management. Some leading RTSM platforms – such as Perceptive eClinical’s advanced RTSM solution – go further than predictive algorithms, offering a trial supply simulation service.

This type of supply forecasting uses sophisticated simulation modeling technology to produce estimations for study supply requirements.

Simulation tools such as Perceptive RTSM’s trial supply simulation service can be integral to drug supply planning, quantifying the risk of stockouts and reducing overages (drugs that are supplied but not used by participants), and, in turn, avoiding drug wastage. These tools are also able to simulate possible outcomes, which can help to identify potential bottlenecks and allocation constraints.

The right technology and expertise for trial supply management

Perceptive eClinical’s RTSM presents global sponsors and trial investigators with a range of advanced inventory management options to optimize site supplies.

With these robust inventory management approaches, coupled with the expertise of Perceptive’s supply experts and RTSM specialists, we can ensure that your trial has the right drug available at the right time for each participant.

Learn more about Perceptive eClinical’s RTSM solutions for clinical trial supply management or contact a Perceptive trial supply consultant today

REF McKinsey 2021 Clinical supply chains: How to boost excellence and innovation | McKinsey