CRO for NAFLD/NASH Clinical Research

Your CRO of Choice for NAFLD/NASH Studies

Accelerate your NAFLD/NASH study with Medpace’s noted medical and regulatory experts, highly experienced clinical trial management teams, central labs, and imaging core labs

Gain a competitive edge for your non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH) study by partnering with a scientifically-driven clinical research organization that has the experience and relationships in place to get your study up and running as soon as possible. As a therapeutically-aligned CRO, Medpace has the relevant and recent gastroenterology and hepatology experience to successfully navigate the complexities and regulatory scrutiny involved with these programs. Our experience, coupled with our strong relationships with KOLs and investigative sites and our in-house central lab and imaging core lab services, set you up for long term success.

Why Choose Medpace for NAFLD/NASH Studies?

NAFLD/NASH trial experience since 2010
In-house teams experienced in successful execution of NAFLD/NASH trials with endpoints including labs, imaging, and biopsy
Wholly-owned central lab with validated NASH soluble inflammation and fibrosis biomarkers
Well established relationships with KOLs and high producing quality sites
Wholly-owned imaging core lab to support NAFLD/NASH studies, ensuring imaging components such as MRE, MRI-PDFF and MRS are seamlessly integrated into the complex structure of the overall trial
Established processes and relationships for central pathology assessments
Hands-on regulatory affairs to guide you through the fastest path to commercial success

Leverage Our Therapeutic Expertise throughout the Trial Lifecycle

Our therapeutically aligned project teams serve as an extension of your team – providing additional medical, regulatory and operational expertise to your study. You benefit from:

In-house physicians that are embedded into the study from project initiation to completion, providing hands-on leadership and translating medical knowledge into execution
Seasoned and highly-trained operational teams with extensive experience in managing GI and hepatology studies, including recent experience in NAFLD/NASH
Global regulatory experts, including former FDA officials, who can add input, strategy, and efficiencies based on their in-depth understanding of the local and global regulatory landscape

Central Laboratory Capabilities

With laboratories in the US, Europe, China and Singapore, Medpace Labs has the global reach and capabilities to conduct NAFLD/NASH studies in concert with our full-service CRO or as a standalone service.

Biomarker Strategic Services

Medpace Labs’ test menu includes many validated biomarkers associated with NAFLD/NASH:

A2 Macroglobulin	C Peptide	Free Glycerol	NAS Calculation
Adiponectin Total	Chylomicrons	Fructosamine	NMR
Aldolase	CK18 M30	G6PD	P1NP
ANGPTL3	CK18 M65	Ghrelin	PIIINP
ANGPTL4	Cortisol Salivary	Glucose	Phosphatidylethanol
Anti TPO	CRP, hs	GLP-1 Active	Pro BNP
Apo A1	CTX Beta Crosslaps	GLP-1 Total	Pro C3
Apo B	Cystatin C	Hyaluronic Acid	Proinsulin
Apo B 48	D Dimer	Haptoglobin	Pyruvic Acid
Apo B 100	ELF Panel	IL1 beta	Resistin
Apo CII	Ferritin	IL6	sLDL
Apo CIII	FIB4 Calculation	Insulin	TGF Beta 1
APR Calculation	Fibrinogen	Lactate	TIMP-1
Autotaxin	Fibronectin	Leptin	TNF alpha
Beta Hydroxybutyrate	Fibrotest	Lp(a)	Troponin I
Bile Acids Fraction	FGF-19	Lipid Panel	Vitamin D 25 OH
Bile Acids Total	FGF-21	MCP-1	YKL-40
C4 (7-alpha)	Free Fatty Acids	NAFLD Calculation

Our test menu also includes validated assays used in NASH fibrosis scores such as Fibrotest/FibroMax and ELF (Enhanced Liver Fibrosis).

Specialized Imaging for NAFLD/NASH Clinical Research

High-quality image acquisition and interpretation is crucial for the success of NAFLD/NASH trials. Medpace Core Labs provides comprehensive central imaging services including site assessment, qualification and training, advanced data processing and blinded assessments. In particular, Medpace Core Labs has expertise with the implementation of various MR-Based acquisition techniques including Magnetic Resonance Spectroscopy (MRS), Proton Density Fat Fraction (MRI-PDFF; magnitude and complex) and Magnetic Resonance Elastography (MRE) to support imaging endpoints for NAFLD/NASH trials using fully regulatory-compliant platforms.