As outlined in their published guidelines, the FDA mandates that pharmaceutical sponsors conduct pharmacokinetic (PK) studies in patients with impaired renal and hepatic function. With deep experience in executing these trials and our relationship with our ERG network of specialized sites with recruitment expertise in this therapeutic area, Lotus Clinical Research is a powerful ally.
Nearly all the recent successful renal/hepatic impairment trials across multiple indications in the U.S. have been run through Lotus or our ERG sites. In the last year alone, we conducted six renal or hepatic impairment trials, a few of which were “rescued” from other CROs. How do we do it? We simply have better access to the patient population.