Contents 26
26 Clinical trials and tribulations
Even though they’re often a vital conduit between the drug and patient, ancillary supplies are sometimes seen as an afterthought for sponsors, who have been known to request items at the last minute. Medical equipment shortages during the pandemic made it much harder to secure the right tools for the right trial and, in the process, thrust the important role they play into the spotlight. Elly Earls speaks to Sanjay Vyas, executive vice- president of Parexel India and head of clinical trial supplies and logistics, and AbbVie’s clinical supply project manager, Aaron Steinbrecher, to find out how Covid-19 has led to more complexity in the sourcing of ancillary supplies and what strategies they’ve employed to keep trials running.
29 Stay ahead of the ancillary supply chain Ancillare
Clinical data management
30 Rise to the challenge Running a clinical trial can be a difficult process at the best of times, but the level of complexity can be orders of magnitude higher when it comes to rare disease research. Technology can help overcome some challenges, but are there methods out there that could lead to a paradigm shift for the better? Mae Losasso asks Andrea Bastek, director of innovation at Florence Healthcare, and Sir Mark Caulfield, professor of Clinical Pharmacology at the William Harvey Research Institute in Queen Mary University of London and a primary investigator on the ‘100,000 Genomes
Pilot on Rare-Disease Diagnosis in Health Care – Preliminary Report’.
Outsourcing
34 Choosing the right central lab Central laboratories have become an important part of running global clinical trials in Europe and the US. With the rapid increase in the number of studies conducted in China and other Asia Pacific countries, sponsors should understand how to choose central labs in these regions too. Kim Thomas asks Honggang Bi, senior vice-president and head of APAC at Labcorp Drug Development, and Michael W Young, principal at biomedwoRx: Life Sciences Consulting, what sponsors should look for when outsourcing to a central lab.
39 Decentralised clinical trials oversight management Lumis Life Science Consulting
Packaging
40 Subject to requirements Clinical trial materials each have unique packaging requirements, and there are also a number of processes and systems to consider that can help to minimise delays and ensure a swift delivery. Bruce Hastings, managing principal at De Mi Tierra Consulting and former director of process technology at Amgen, discusses with Lyn Eyb how packaging can optimise trial efficiency.
6 Clinical Trials Insight /
www.worldpharmaceuticals.net 30
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