Insights
Notes from the teams running the trials.
Study design, regulatory change, real-world evidence and what we are learning across five countries and more than twenty markets.
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Decentralised monitoring, eight years on: what risk-based actually changed
Moving monitoring onto a remote and risk-based footing did not reduce oversight. It moved the work earlier, and the sites new to it need more support, not less.
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EU CTR at three years: lessons from our first fifty submissions
The single dossier is real. The single timeline is not, and most of the requests for information we have handled were national rather than scientific.
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What payers ask for that your Phase III never collected
Comparator relevance, resource use and a second patient-reported timepoint. All three are cheap at the design stage and expensive to reconstruct from a registry.
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Recruiting in Latin America: why site selection beats site count
Twenty sites contributing one patient each is a monitoring burden, not a recruitment strategy. What our Bogota team checks before a site goes on the list.
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Expanded biostatistics and data management capacity in India
Additional statistical programming and bioinformatics staff give clients follow-the-sun data review across the Montreal, Warsaw and India teams.
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Writing a protocol that a monitor can actually follow
A protocol has two audiences, and the one that decides whether the study produces usable data is a coordinator with a patient in the chair.