Renal and Hepatic Insufficiency (RI/HI)
Unparalleled Experience in Renal and Hepatic Disease Clinical Trials
Spaulding Clinical’s experience in renal and hepatic diseases allows us to offer faster, evidence-based decision-making while designing and performing your Phase I clinical trial.
Spaulding Clinical has designed, conducted, analyzed, and reported on renal impaired (RI) and hepatic impaired (HI) studies since our inception. We ensure quality by partnering with leading physicians, guaranteeing our renal and hepatic impaired participants have the specialized clinical oversight they need — while streamlining access to the right potential participant populations for your study.
Are You Planning for the Unexpected in Renal and Hepatic Insufficiency?
Clinical research for renal and hepatic diseases isn’t just about moving from step A, to B, to C. It is also about adjacent disease conditions (ADCs). Spaulding Clinical has the expertise in planning for ADCs during research trial design and executing on those plans during your Phase I clinical trial. When planning for a Phase I trial, we make sure you understand how ADCs could complicate your specific study. From creating the matching strategy for statistical analysis to determining the type of study design, we can tailor every process, protocol, and system to create the ideal environment to facilitate your research:
- Is it a full or reduced design?
- What are the particulars of dialysis assessment?
- What about dosing adjustment effects?
Examples of ADCs:
- Altered mineral metabolism
- Atherosclerotic cardiovascular disease
- Cardiovascular disease
- Diabetes and diabetic complications
- Dialysis adequacy
- Home dialysis
- Nutrition management
- Peritoneal dialysis
- Rare diseases
- Vascular access
Resolving Difficulties With Renal and Hepatic Insufficiency Special Population
Spaulding Clinical offers development of a robust study design by clinical and scientific experts with the knowledge to design both the study and interpret its results. We examine the PK/PD properties of the drug, drawing on our understanding of the fundamental PK principles related to RI and HI pathologies.
Some of the most difficult work in early drug development can be in planning, interpreting, and creating reproducible data in RI/HI populations — especially as these drugs frequently have systemic absorption. The conclusions from these early phase RI/HI trials are often variable and unclear. Spaulding’s expert team works as an extension of yours to best focus on actionable data.