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International Clinical Trials

So, You Want to Run a Decentralised Clinical Trial…

With the pandemic having catapulted decentralised clinical trials (DCTs) from a pipedream to a reality, it’s time to think carefully about what’s actually involved – particularly as it relates to the interactive response technology (IRT) system supporting virtual and hybrid trials. When contemplating a trial to be conducted virtually, either in its entirety or in part, sponsors should be aware of all the implications for the IRT and how it will randomise patients, raise drug shipments, and track drug assignments, dispensing, and returns. A new set of processes, communication pathways, and safeguards must be in place to ensure patient safety, data integrity, and regulatory compliance, not to mention smooth and efficient operations.

The IRT functions required to support DCT elements should be fully discussed and carefully considered as the protocol is being developed. While much is possible with a sophisticated and flexible IRT system, not everything that’s possible is advisable in a given situation. It’s important to be able to distinguish functionality that’s essential from what is only nice to have or even what may add unnecessary complexity.

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About the Author

As the Head of Strategic Partnerships and Alliances at Almac Clinical Technologies, Mike Hutton oversees several key clients along with developing new and exciting business, partnership, and alliance opportunities in the EU and the rest of the world with Almac’s IRT solutions.

As a Strategic Account Manager at Almac Clinical Technologies, Ivan Hanley has oversight for the commercial and operational activity for key Almac strategic partner sponsors. A key focus for Ivan is the implementation of robust innovative solutions that align with sponsor requirements and drug development industry trends.

Matt Lowrie, ASQ CQA Quality Assurance Manager, has 18 years of experience within the pharmaceutical world with an extensive focus on regulatory inspections, auditing, software, and risk management. Matt currently oversees Almac Clinical Technologies quality group for these areas and is the host of the Spotlight on IRT podcast.
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