Situation

  • Phase III multi-center, double-blind, randomized, placebo-controlled study
  • 150 patients
  • 80+ sites across 25 countries

Challenge

The sponsor was concerned that the following factors would cause a very high level of drug wastage:

  • Large number of sites
  • Clinical supplies team did not have the capacity to closely monitor sites

Solution:

Calyx supply chain experts recommended Calyx IRT’s automated supply scheme management to:

  • Ensure each site is appropriately stocked by changing the IMP supply levels to match current recruitment rate
  • Take the burden off the clinical supplies manager
  • Minimize drug wastage
Identify which sites are active
Assess the site based on defined parameters
Switch the supply scheme, if needed
Generate shipment specific to the site’s needs

What is a supply scheme?

Supply schemes determine what stock is sent to a site; they combine site needs for both:

Buffer:

  • for randomization & for unplanned needs, for example, replacing damaged stock
  • quantities based on assumptions made at the start of the trial

Prediction:

  • typically, for subjects from randomization onwards
  • quantities based on subject treatment group, dosing regimen & visit schedule

Typical IRT approach

When the site is first activated, a scheme is selected based on the expected recruitment rate; this can be changed by the clinical supply manager via the IRT whenever the actual recruitment rate differs, so requires active monitoring

Advanced IRT approach

Automated supply scheme management differs as a site’s scheme is automatically changed to align with its actual recruitment rate.

The automated supply scheme management process:

For this study, Calyx IRT ensured that all subjects currently in screening could be randomized (and for this design received 1 kit of active or placebo).

The stock in the initial shipment was based on a dynamic count of subjects actively in screening at the site

The stock in the resupply shipments was based on a dynamic count of subjects actively in screening at the site

The quantities to ship per scheme were defined based on assumptions at the start of the trial with the support of the study’s dedicated Calyx IRT randomization and trial supply expert.  Clinical Supply Managers were able to amend those quantities through Calyx IRT self-service tools, once real-world patient and site data was available.

The Calyx IRT design also included:

  • The option for the clinical supplies team to easily override the automated supply scheme switch via our inventory management web system
  • Country-specific opt-outs for the automated process
  • Specific supply schemes for locations with a long lead time for shipments

Result:

By using Calyx IRT to automatically optimize the supply scheme for the site’s current recruitment situation, the sponsor was able to:

  • Relieve the clinical supply manager’s burden of closely monitoring each site’s supply levels against patient recruitment
  • Avoid failed patient visits due to insufficient medication
  • Ensure that each site is on the optimum supply scheme for their current recruitment rate
  • Keep drug wastage to a minimum

More on automated supply scheme management

Automated Supply Scheme Management is one of Calyx IRT’s advanced trial supply management options; it’s a flexible approach that can be tailored to specific protocol requirements and supply criteria.

The approach can be helpful for any type of study but is particularly useful at reducing the burden on the clinical supply manager when there are many sites.

Trials which benefit most

Large trials with many sites

Trials with a combination of local and central sourcing of IMP

  • The greater number of IMP types, the larger the possible combinations for resupply strategies
  • Automated switching would be used to assign a strategy based on the source settings for a site

Comparator trials where the comparator is known to be different based on patient characteristics

  • Automated switching could be used to monitor the level of comparator medication based on the number of patients with the required characteristic

Calyx RTSM expertise

Our dedicated IRT randomization and trial supply experts are here to help with any questions related to advanced trial supply management.

If you are interested in using automated supply scheme management, Calyx RTSM experts can assess the suitability of the method for your design considering:

  • Number of sites
  • Recruitment rates
  • Supply of future visits
  • Medication costs
  • Medication availability

Stay Updated

Never miss a beat. Sign up to receive emails covering industry news and useful content to help you advance clinical development.

  • This field is for validation purposes and should be left unchanged.