BACKGROUND

A leading pharmaceutical company selected Calyx IRT to provide randomization and trial supply management (RTSM) services for two Phase III, multi-country studies. During trial execution, a safety regulation was issued that required the company to modify its primary packaging due to safety risk concerns for some patients.

This unexpected study change was complicated in that it only affected sites in a single country and each trial had at least 12 countries participating.

At the time, the inventory was already in use across all sites and all countries, with several hundred patients enrolled and randomized, and the trials were barely at the halfway mark.

The client came to our team with a date when the new inventory needed to start being dispensed for patient visits based on the regulatory requirements. So, the experts behind Calyx IRT went to work.

CHALLENGE

This situation presented several unique challenges in that, for the study to continue as planned, the sponsor had to ensure new inventory could be shipped to the sites in advance of, but not dispensed to patients until the transition date. This meant the sponsor must:

  • Enable sites to continue dispensing current inventory in its original form up until the required date of transition
  • Produce and ship the new inventory so that sites would have it available to dispense when ready
  • Ensure, at the time of transition, all the old inventory was removed from the impacted sites
KEY HIGHLIGHTS
IN CLINICAL TRIALS, NOTHING GOES ACCORDING TO PLAN.

In this case:

  • Safety regulation issued mid-way through two Phase 3 trials
  • The change only affected one country
  • Each of the sponsor’s trials involved 12 countries
  • New inventory had to be shipped to affected sites before the changeover date
  • New inventory couldn’t be dispensed until after the changeover date
  • Old inventory had to be collected and destroyed
  • The system allowed the sponsor to determine when they were ready for their depots to ship new inventory
  • Calyx enabled the sponsor to remain compliant and continue their trials with no disruption to patient visits

Rely on Calyx IRT to tackle all your unexpected study challenges

SOLUTION

Calyx gathered a team of internal experts to discuss the best approach for this transition. This team included the study’s project manager –
who understood the sponsor’s IRT standards – a solutions designer, validation engineers, customer service representatives, and our statistical design and trial supply consultants.

Together, the team reviewed the study team’s needs and discussed the options to accommodate this new regulatory requirement. The goal was to build a structured transition plan to ensure on-time compliance with the new requirement.

The resulting solution was multi-phase:

  • While the sponsor was packaging the new inventory, Calyx planned the updates to country- and batch-level inventory management settings. Calyx IRT provided intricate control over what was being shipped to which countries and when, including the prioritization of batches.
  • This transpired while the existing IRT system also continued shipping and dispensing only the current inventory for patient resupply needs.
  • Shipping the new inventory was one part of the challenge. Once the new inventory arrived on site, Calyx had to complete the transition in line with the sponsor’s date requirement without impacting patient visits.
  • When the transition date arrived, the Calyx team coordinated removing the old inventory from site stock. The system also ensured the country settings were all automatically set so future shipping and dispensation only included the new inventory.

RESULT

The sponsor was delighted with Calyx’s commitment to finding a solution and the flexibility built into Calyx’s IRT system that enabled them to meet their trials’ changing RTSM needs. Even though the deadline date was postponed, because the Calyx solution was flexible and future-proof, the change-over occurred without any problems. Patient enrollment continued, dispensation visits occurred, the original inventory was destroyed, and the company met the deadline, keeping them compliant with this important regulatory change.

Contact hello@calyx.ai to learn how Calyx IRT can help your clinical trial succeed.


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