Unparalleled Access to Renally & Hepatically Impaired Populations

Renal insufficiency studies

Hepatic impairment studies

0 %

Of early-phase trials are in patients with renal and hepatic impairment

Statistics combine experience from both Lotus Clinical Research and Evolution Research Group’s network of clinical research sites.

An Industry-leader in Renal & Hepatic Clinical Development

Regulatory agencies, including the FDA, require pharmacokinetic (PK) studies in patients with renal and hepatic impairment to assess drug metabolism and dosing adjustments. With extensive experience in patient recruitment and trial execution, we provide biopharmaceutical companies with the expertise needed to navigate these critical studies efficiently.

Renal Impairment Studies

Our robust patient database allows for precise identification and enrollment of participants with varying degrees of renal impairment, ensuring comprehensive study data.

Mild to moderate impairment: We maintain an extensive network of pre-screened candidates for efficient enrollment.
Severe impairment & end-stage renal disease (ESRD): Since most patients with severe renal impairment or ESRD require dialysis, our in-house dialysis at CPMI allows us to have even greater control in managing your study. We also leverage strong partnerships with local dialysis centers and collaborate with specialized investigators to ensure timely recruitment and study execution.

Hepatic Impairment Studies

Patients with hepatic impairment often have underlying conditions that impact study feasibility. We have access to a broad spectrum of patient populations, allowing for seamless recruitment across patient populations including:

Metabolic dysfunction-associated steatohepatitis (MASH) and alcohol-related liver disease
Child-Pugh A, B, and C classifications

By working closely with specialist physicians, we ensure access to well-profiled patients, minimizing recruitment delays and optimizing study timelines.

COMING to CPMI in 2025: In-house Dialysis Unit

CPMI is a preferred site for renal and hepatic studies. And with an in-house dialysis unit coming to the facility in late 2025, Sponsors will be able to achieve even greater efficiencies in conducting Phase I research.

Spotlight on ERG Leadership in Renal and Hepatic Clinical Pharmacology

The medical and operations teams at ERG’s network of sites are recognized for their expertise in conducting renal and hepatic PK studies. Our staff are veterans of thousands of clinical trials, with specialized expertise in renal and hepatic trial design and implementation.

Stacy Dilzer, RN, CCRC

Clinical pharmacology and renal/hepatic

Founder and past President, Clinical Pharmacology of Miami
Sought-after operational leader in early-phase execution and study design
Extensive career in clinical development, including Study Coordinator, Project Manager, Director of Clinical Operations, Chief Compliance Officer, and Vice President of Clinical Operations
Co-authored numerous articles pertaining to clinical pharmacology

Alexander Prezioso, MD

Investigator, Clinical Pharmacology of Miami

Holds Degrees from Università degli Studi di Palermo School of Medicine (MD), and University of Cincinnati (MS)
Holds a Florida and New Jersey Medical License
Board Certified in Obstetrics and Gynecology
Published extensively on peer-reviewed journal articles
Extensive research experience with complex Phase 1 clinical trials, Healthy Volunteer populations, and Migraine indications.

Your Trusted Partner in Hepatic & Renal Impairment Trials

With specialized recruitment strategies, deep investigator networks, and extensive experience conducting PK studies, we help biopharmaceutical companies efficiently generate high-quality data to meet regulatory requirements and advance drug development.

Contact us to discuss how we can support your next clinical trial.