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| home > ict > autumn 2021 > so, you want to run a decentralised clinical trial… |
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 PUBLICATIONS |
International Clinical Trials
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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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