Impaired Renal Function Clinical Trials – Early Phase Planning to Minimize Risks and Accelerate Drug Development
Algorithme Pharma presents a clinical trial case study in patients with impaired renal function to examine the impact of four renal impairment stage levels on an investigational drug’s pharmacokinetic and safety characteristics.
Our clinical team partnered with a hospital offering nephrology expertise who had access to the required patient population to run stages 3 and 4. In parallel, stages 1 and 2 were conducted at our facility.
Algorithme Pharma strategically managed all aspects of this complex clinical trial. With our optimal study design, we were able to accelerate our sponsor’s project timelines by 3 to 5 months, from writing the protocol to completing the clinical trial. The key was to incorporate patients effectively and efficiently, while preserving result integrity and patient safety.
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