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International Clinical Trials

Seek a System that Makes the Complex, Simple


As a way to increase clinical trial productivity, sponsors are increasingly turning to adaptive trial designs to gather more information, involve fewer patients, and improve the ethical treatment of patients – especially in oncology and rare diseases (1). So too, sponsors in these therapy areas are finding that platform trials that use master protocols can increase efficiency and accelerate development timelines.

Still, these modern trial designs are not yet common because they’re complex to manage and present more risk than the traditional series of trials that investigate one drug using a typical blocked randomisation design. The complexities extend to programming and configuring the interactive response technology (IRT) system that supports patient randomisation, drug assignment, and supply management.

Although the industry generally places a premium on accelerating IRT start-up timelines, in the case of these complex trials, sponsors are better served to focus on the experience of the vendor and the quality/thoroughness of the work. The adage, ‘more haste, less speed’ applies here.

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Sylvain Berthelot is an IRT Technical Solutions Director at Calyx. Sylvain applies innovative solutions to reduce the technology burden imposed on sites, allowing them to focus on what is the most important: patients. Over his 10 years in the industry, Sylvain has managed product strategy for various eClinical solutions such as IRT, EDC, eCOA, and patient sensors. He is now one of the driving forces behind Calyx’s IRT product innovation.

sylvain.berthelot@calyx.ai


Malcolm Morrissey is an Associate Director, Statistics and Product Support Services at Calyx. Since obtaining a PhD in Statistical Inference in 2001, Malcolm has had broad experience as a research associate, statistician, and manager in the pharmaceutical industry. He joined Calyx in 2005 and currently manages a team whose duties include supporting and developing randomisation and medication management algorithms for clinical trials managed by IRT.

malcolm.morrissey@calyx.ai
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