Contents In this issue Cover story 37
6 News & numbers The headlines and figures impacting the sector.
Regulatory
8 Screened through a screen Once enough support builds to integrate a new technology to support clinical trials, the FDA responds. That’s exactly what happened early this year – with a new document on the use of digital health technologies (DHTs) and remote data acquisition making waves across the industry. Andrea
Valentino speaks to Jennifer Goldsack at the Digital Medicine Society, and Lindsay Kehoe at the Clinical Trials Transformation Initiative, to understand what the guidance says, how it speaks to the wide prevalence of digital trials across the sector and how trial conveners will have to tackle cybersecurity and data analysis challenges if they want this emerging field to grow even further.
11 A real insight into the patient experience A Life in a Day
12 The lay protocol synopsis Trilogy Writing & Consulting
Clinical supplies & logistics
15 Waste not want not When you’re trying to prove the benefits of an exciting new investigational medicinal product, or even study the possibility to repurpose approved drugs for new treatments, it’s easy to get laser focused on the data and not think so much about the potential for wastage. But what if trial organisers could implement design principles that help keep waste to a minimum from the offset, and in turn save on costs? Monica Karpinski finds out from Professor Shaun Treweek, chair of Health Services Research at the University of Aberdeen; Dr Cristina Richie, lecturer in philosophy and ethics of technology at Delft University of Technology and James Connelly, CEO of not-for-profit organisation My Green Labs.
21 Ensuring the integrity of your product Clinigen
22 Optimal supply
The world of supply chain management involves a myriad of sourcing strategies, but clinical trials have very specific needs, which can differ depending on the structure and design of each trial. Jim Banks speaks to Joab Williamson, clinical supply chain manager at Faron Pharmaceuticals, to find out what must be considered to ensure an effective sourcing strategy for a clinical trial.
25 Optimising waste in today’s clinical landscapes Oximio
27 Seamless CDMO solutions PCI Pharma Services
29 The next step to 8 4
automating clinical trials TSS
Temperature control 30 Up in the air
Clinical Trials Insight /
www.worldpharmaceuticals.net
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