Asset Type: Case Studies, eClinical, eClinical

Optimizing Supplies with Perceptive IRT: Ensure Patient Supply while Limiting Buffer

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:

Perceptive 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, Perceptive IRT sends medication to each site based on upcoming treatment group assignments known from the randomization list

Perceptive 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 Perceptive 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, Perceptive 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

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