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Clinical data management


Increased use of mobile apps in clinical trials promises interconnected ecosystems, faster studies, and access to continuous data – all at the touch of a button. But just how crucial are these apps in the wider landscape of emerging digital healthcare technologies? Mae Losasso speaks to John Zibert, CEO of Studies&Me, Leonard Sacks, associate director for clinical methodology at the FDA, and Ryan Shaw, faculty lead on Duke University Mobile App Gateway, to find out more.


Remote control J


ohn Zibert, CEO of Studies&Me, dials into our virtual meeting from his home. “I’m in a big forest ” he says, “just north of Copenhagen. It’s been good during Corona, just to have walks around.”


ohn Zibert, CEO of Studies&Me, dials into our virtual meeting from his home. “I’m in a big forest,” he says, “just north of Copenhagen. It’,


been good during Corona, just to have walks around.” It’s something that’s been heard a lot over the past


It’s something that’s been heard a lot over the past 18 months: more and more people migrating out


18 months: more and more people migrating out of big cities to discover the virtues of working from


people have learnt to do from home. For the past few years, clinical trial designers


of big cities to discover the virtues of working from home – however remote that may be. But it’s not an


For the past few years, clinical trial designers around the world have been working strenuously to


around the world have been working strenuously to make studies more remote, more decentralised and


make studies more remote, more decentralised and more virtual. The Covid-19 crisis might have created


more virtual. The Covid-19 crisis might have created the perfect storm, but the systems and technologies that have made remote activities possible were in


the perfect storm, but the systems and technologies that have made remote activities possible were in


home – however remote that may be. But it’s not an altogether new refrain; and it’s not only working that


altogether new refrain; and it’s not only working that people have learnt to do from home.


place long before the pandemic. “I wouldn’t say


place long before the pandemic. “I wouldn’t say that everything was smooth under Covid-19,” Zibert


that everything was smooth under Covid-19,” Zibert admits, “but one thing’s for sure, it raised some


admits, “but one thing’s for sure, it raised some awareness about this industry; it promoted us, . A lot of regulators suddenly saw that


awareness about this industry; it promoted us, indirectlyindirectly. A lot of regulators suddenly saw that e-consenting, IP [investigation product] distribution


e-consenting, IP [investigation product] distribution to the patient’s home, and remote visits can be done.” Zibert set up Studies&Me, Europe’s first virtual


to the patient’s home, and remote visits can be done.” Zibert set up Studies&Me, Europe’s first virtual contract research organisation, back in 2015. “I had


contract research organisation, back in 2015. “I had this passion for doing things differently,” he explains.


this passion for doing things differently,” he explains. “I felt that the way that we conducted clinical trials was a little bit too narrow and too little focused on the greater good of the patient. Wi


“I felt that the way that we conducted clinical trials was a little bit too narrow and too little focused on the greater good of the pat ent. We j just saw patients llike a lab mouse that you wanted to treat. So, howike a lab mouse that you wanted to treat. So, how could we make it even more personal?” Zibert and a team of four piloted a trial of fish oil tablets.


could we make it even more personal?” Zibert and a team of four piloted a trial of fish oil tablets.


ust saw patients


40 40


Clinical Trials Insight / www.worldpharmaceuticals.net Clinical Trials Insight / www.worldpharmaceuticals.net


Girts Ragelis/Shutterstock.com


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