Outsourcing
Virtual trial and error F
rom the rise of digital medicine and fast- tracked vaccine development to the upscaling of devices manufacturing, healthcare as the world knew it in 2019 is gone forever. Covid-19 has irrevocably altered the pharmaceutical landscape – and nowhere is this more evident than in the clinical trials space. As the world locked down and vaccine research ramped up, other trials ground to a halt as sponsors looked online for digital solutions to not only salvage existing research, but also safeguard future studies. One company better placed than most to adapt to the changing landscape was Lundbeck – the Danish pharma was at the forefront of digitalising its clinical development when Covid-19 hit. “You cannot be everywhere with everything, so we had to concentrate our resources, and one of the things we decided to zoom in on and prioritise was
Clinical Trials Insight /
www.worldpharmaceuticals.net
the decentralisation of trials,” explains Mads Dalsgaard, senior vice-president, head of experimental medicine and clinical development at Lundbeck. That was five years ago – and a corporate digital strategy followed. All processes were put under the microscope and reviewed in terms of their potential for digitalisation – from site selection to monitoring and oversight, population selection and refinement, and back end development.
“Around the same time, we started to look at vendors that allowed decentralisation,” says Dalsgaard. “It’s one thing to have the patient at home, but there’s a whole infrastructure around getting the data and understanding how to analyse it. And then, of course, also having assessments and interactions that can be done remotely. We started to do all this gradually and slowly.”
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To withstand the disruption seen during Covid-19, clinical trials need to be responsive to the needs and abilities of all stakeholders. As more and more research moves out of the clinic and into the home, Lynette Eyb speaks to Mads Dalsgaard, senior vice-president, head of experimental medicine and clinical development at Lundbeck, about decentralisation and the challenges of operating trials in a virtual setting.
Andrey Suslov; Yurchanka Siarhei/
Shutterstock.com
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