RFP

Situation

  • Phase III study evaluating the efficacy of 2 different doses of active drug compared with placebo
  • 500 patients
  • 80+ sites participating across six countries
  • Site stratification

Challenge

  • IMP was very expensive, so ensuring patient supply while limiting overage was critical
  • Storage of medication was limited for many sites

Solution:

  • Calyx RTSM experts recommended “randomization prediction,” one of our advanced trial supply management options; this sends only the exact medication a site will use for upcoming patient randomization
  • Traditional IRT solutions base site stock levels on the expected number of randomizations and the amount of medication used for each treatment group
  • With randomization prediction, Calyx IRT sends medication to each site based on upcoming treatment group assignments known from the randomization list
  • Calyx RTSM experts worked with the sponsor to understand the expected site recruitment rates and recommended a range of supply strategies including low, medium, and high recruiter

We determined how many randomization list records’ worth of medication would be covered per supply strategy

Result

  • Randomization prediction ensured a reduction in overage by removing the buffer
  • The stock required to be shipped to the site was reduced, as shipments contained specific medication for randomization assignments
  • Patients had the right drug at the right time

Randomization Prediction

Randomization prediction is one of Calyx IRT’s advanced trial supply management options; a flexible approach that can be tailored to specific protocol requirements & supply criteria.

If your study stratifies by site, Calyx IRT can send IMP to each site specific to upcoming treatment group assignments; this ensures overage is reduced.

Additional Features

— Can also cover medication needs for the next visit; beneficial if the next dosing visit is close to randomization

— Can be used with another stratification factor, in addition to site

— Does not require sites to have all types of medication for a randomization to proceed

— Can be combined with standard buffer & prediction strategies

  • Covering subsequent visits
  • Including buffer stock in case of IMP damage

Calyx RTSM Expertise

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

If you are interested in using randomization prediction, Calyx RTSM experts can assess the suitability of the method for your design considering:

  • Recruitment rates
  • Supply of future visits
  • Blinding considerations
  • Randomization and statistical considerations

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