Contents
23 Precision micro-dosing for clinical development PCI Pharma Services
25 The real-world impact of data gaps in clinical trials TSS
27 The evolving environment of clinical trial sourcing Myonex
29 Effective comparator sourcing amid a pandemic Clinigen Clinical Supplies Management
30 Go to waste
The supply slowdowns caused by the pandemic highlighted the importance of building redundancy and flexibility into the supply chain. A Herculean effort to keep clinical trials going focused the industry on cost- efficiency and the risk of waste, while in the background long-term issues such as climate change accentuated the same issues. Jim Banks speaks to Steven Jacobs, chairman of the board at Global BioPharm Solutions and a board member of the Global Clinical Supplies Group (GCSG), and Aaron Steinbrecher, clinical supply project manager at AbbVie, to examine how sponsors overcame the challenges presented by the pandemic, and how this will shape a more sustainable and efficient approach in the future.
Clinical Trials Insight /
www.worldpharmaceuticals.net
Outsourcing
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33 Virtual trial and error 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.
37 Hybrid FIH trials: 40
Advantages and challenges SGS
39 Managing vendors means managing relationships Lumis Life Science Consulting
Clinical data management 40 Remote control
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 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.
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