What sponsors get wrong about renal & hepatic studies
Dear Kenneth,
Renal and hepatic impairment studies are treated, by most development teams, as something to schedule and deliver. The clinical nuance, the recruitment complexity, the design decisions that directly affect regulatory outcomes — these tend to be underestimated until they become a problem.
By which point, the options are limited.
Dr Maria Lehretz, Medical Director at hVIVO’s specialist unit in Kiel, reveals the six misconceptions that most consistently cause programmes to stall — and shows what getting these studies right actually requires.
Key insights include
● Why not all early-phase units are equipped for impaired-population research — and the infrastructure that genuinely makes the difference
● The regulatory pathway questions that must be resolved before study design begins — and what happens when they are not
● Why recruitment timelines vary significantly across impairment categories, and why assuming otherwise is one of the fastest ways to derail a study plan
● How hVIVO has engineered quality into its RI/HI processes — and why quality in these studies is never automatic
● Why engaging an experienced specialist unit early is the single most effective way to protect approval timelines
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