Perceptive IRT was the system of choice for a study including patients admitted to intensive care units (ICUs) due to COVID-19-related problems. The trial was managed by a CRO, and Perceptive collaborated closely with both the CRO and the sponsor team.
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On paper, the trial had a fairly simple IRT design, aiming to determine whether the study medication would reduce time spent in the intensive care unit.
Patients were recruited to the study upon admission, treated in the ICU, and dosed up to six times over 28 days or until discharge, whichever occurred first.
From the outset of the study, a depot network had been constructed, and supplies were sent to sites based on expected recruitment rates. However, clinical trials rarely go as planned.
Challenge
During the trial, the sponsor had to replace the distribution providers because they were dissatisfied with the initially selected provider. The transfer had to be made in flight, while sites were still recruiting, without disrupting supply to sites or patient recruitment.
During the final 10 months of the research, the sponsor faced a crucial medication management scenario. Due to a longer-than-anticipated start-up period, the medication stored at depots and sites was nearing expiry.
Without more stock and no time to manufacture more medication, they risked being unable to supply patients with medication, causing the experiment to end before reaching the required sample size.
Solution
The Perceptive project manager used their experience managing comparable circumstances to meet the sponsor's problems.
Switching distribution vendor
Perceptive IRT provides standard integrations for distribution suppliers used in this study. Switching vendors mid-research required modifying the depot network and implementing different integration standards to ensure ease of use for the new distribution vendor.
Fortunately, Perceptive IRT inventory management has flexible settings designed to handle unexpected scenarios like this one. The Perceptive team used those parameters to enhance pharmaceutical stockpiles at sites, anticipating that supplies would need to last longer during the depot transition phase.
Perceptive assisted the clinical supplies team in transporting medication to the new depots and releasing it for use after it was confirmed available at the new locations. The depot shift and new integration were invisible to sites.
The Perceptive project manager was essential in advising the CRO and sponsor on how to approach this scenario and in proposing the best available options. They coordinated the required updates and released them at the appropriate times, in accordance with the physical transfer of the pharmaceutical stock.
Using medication close to expiry
It might be difficult to deal with situations where medication is approaching its expiration date. Perceptive's IRT features adjustable Do Not Ship and Do Not Dispense settings that can be set down to the patient dispensing level if necessary.
Perceptive would typically advise against changing those settings, but its staff has experience and skills to perform those adjustments safely.
In this trial, the Perceptive project manager collaborated closely with the clinical operations team whenever a patient required medicine. This includes proactively updating patient status in the IRT to reduce the risk of prescribing too much medication, thereby enhancing shipment accuracy.
They demonstrated strong communication and prioritization skills, ensuring that inventory management settings were swiftly and appropriately adjusted to enable patient medication dispensing.
The Perceptive project manager kept the study team updated throughout the process, allowing them to establish expectations with monitoring and site personnel.
Result
Because of Perceptive's adaptable technology and strong project management, the sponsor was able to enroll the required number of patients and dispense medication to them without jeopardizing their safety or the trial's success.
The trial was a success, and it supported the sponsor's request to the FDA for Emergency Use Authorization to treat critically ill COVID-19 patients.
About Perceptive
For over 30 years, Perceptive eClinical has been a pioneer in RTSM, building and supporting thousands of studies of all designs, from all therapeutic areas and across all phases.
With industry-leading experts delivering flexible, right-fit solutions to accelerate your trial and safeguard your data, we’re more than just an RTSM provider, we are your ally, in streamlining clinical trials, improving data accuracy, and enhancing participant experience. We help make trials more efficient, reduce costs, and accelerate time to market.
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