Contents In this issue 8
6 News & numbers The headlines and figures impacting the sector.
Regulatory
8 Comparator Sourcing Comparator drugs are a crucial part of clinical trials everywhere; helping researchers understand exactly how their inventions fare against the competition, or even when drugs can work together to offer subjects something new. Yet, with supply chains and international regulations to contend with, the life of a comparator drug expert is far from straightforward. Andrea Valentino
talks to Tom White at Bionical Emas and Terrence Walsh at Regeneron to understand more, and along the way explores how technology and collaboration could make comparators far easier to access.
11 How well-written clinical study protocols get drugs to patients faster Trilogy Writing & Consulting
Trial design
14 Blind faith Trial designs can vary significantly when it comes to how much knowledge the personnel and
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participants involved have. But to what end does this serve? Furthermore, what’s required to ensure that both participants and researchers are unaware of which group has the active pharmaceutical and which has the dummy? Mae Losasso speaks to Professor Mike Clarke, director of the Northern Ireland Clinical Trials Unit at Queen’s University Belfast and Matthew Sydes, professor of clinical trials and methodology at UCL’s MRC Clinical Trials Unit, to learn which situations are best suited for a blinded trial, and how to go about doing so.
Clinical supply & logistics
18 Lessons in logistics Even before the pandemic, researchers were moving away from in-person clinical trials and towards digital alternatives, and the trend was only escalated by the required lockdowns and social distancing. And why not? Offering a range of advantages over traditional alternatives, decentralised clinical trials are revolutionising how the industry works. But with test subjects increasingly dispersed in their own homes, researchers need to ensure their supply chains are up to scratch – which may mean investing in new technologies in areas like data collection. Andrea Valentino investigates, talking to a range of experts from across the industry.
21 Sustainability in clinical supply chain management Clinigen
22 Decentralisation is here to stay Thermo Fisher
25 Sustainable and reusable: The labels of the future Faubel Group
27 The key issues impacting the clinical supply chain Abacus Medicine Pharma Services
Clinical Trials Insight /
www.worldpharmaceuticals.net
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