Hepatology

Unique strategies to accelerate liver drug development

Leverage comprehensive medical, scientific and regulatory expertise in liver disease to empower your clinical trials for success.

Access our rich database of site-specific recruitment performance to optimize site selection and deliver patient recruitment.

Support enrollment and minimize screen failure rates in clinical trials for liver indications.

Experience matters when choosing a partner

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In the last 5 years

254

Liver Studies

5,741

Sites

45,159

Patients

Top Indications
Metabolic dysfunction-associated steatotic liver disease (MASLD/MASH) | Cholestatic liver diseases | Liver cirrhosis and complications
Acute liver indications | Autoimmune liver diseases | Alcoholic liver disease (ALD) | Other rare liver diseases

Pioneering liver trials with decades of applied experience

Access our dedicated team of liver disease experts—each with more than 20 years of experience—who can:

Provide guidance on protocol design, strategic study design, screening paradigms, regulatory strategy and operational strategy
Connect you with KOLs, advocacy groups, sites and MASH (formerly NASH) networks to drive study uptake, expedite start-up and support patient recruitment
Incorporate forward-facing, innovative technology to promote patient-centric solutions in your trial

We’re ready to help you successfully design and deliver your liver disease clinical trial with proven solutions and innovative new approaches.

Delivering unique insights from unparalleled liver data

Hepatology trials face many challenges including low diagnosis rate, high screen failure rates, low recruitment rates and rare disease populations. To proactively address these common problems that impede a study’s progress, we work with proprietary clinical and diagnostic data, which includes our:

Clinical database and recruitment metrics across more than 1000 global hepatology investigators in 50 countries
Global, site-specific data in cholestatic liver disease to target the best recruiting sites
Dashboard with more than 20 MASH studies with cross-trial investigator performance data to help select consistently high-performing sites

Discover the difference of working with a partner committed to improving the lives of patients worldwide as we advance the field of liver disease research through cutting-edge clinical trials and innovative treatments.

Get to know us

“Bringing new efficacious and safe therapies to patients with unmet needs has always been my main driver. I am proud to work with an amazing group of experts on the Fortrea liver team as we apply innovation, accelerate development and make the process more efficient.”

—Claudia Filozof, MD, PhD

An exceptional partnership starts with an experienced team. Browse the bios of our featured team members.

Claudia Filozof, MD, PhD Vice President, Liver Therapeutic Area Head

Peter Alfinito, PhD Executive Director, Strategic Delivery and Growth

Joanne Imperial, MD, FAASLD Senior Medical Director

Marcelo Costa, MD Senior Medical Director

Meet the team

Adding value to clinical trials with early engagement

Emerging biotech sponsors often rely on our expertise to help extend their team’s capabilities. Through early engagement with our medical, regulatory and operational experts, we can:

Help sponsors address challenges in complex liver diseases, such as metabolic dysfunction-associated steatohepatitis (MASH/MASLD)
Create a Clinical Development Plan (CDP) and provide a strategy to succeed in a highly competitive clinical trial landscape
Streamline and adjust inclusion/exclusion criteria
Facilitate introductions to top KOLs for greater insight into current practice and future trends

Count on our team to help execute a comprehensive strategy that addresses the unique challenges of hepatology drug development and meets your specific requirements.

Get the latest hepatology team updates.

We’re sharing our latest news, events and publications.

White Paper

Learn about the challenges of advancing clinical studies in Alcohol Associated Liver Disease

View study

White Paper

Conducting pediatric trials in Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD).

View study

Video

Updates on Acute Chronic Liver Failure and Alcoholic Hepatitis with Dr. Imperial and Dr. Costa. (11 minutes)

Watch the video

case study

Read our lessons learned from 14 MASH trials over the last four years.

Read the case study

White Paper

Development pathways and trial design for liver cirrhosis secondary to MASH

View White Paper

Your needs. Our solutions.

As a provider of comprehensive Phase I through IV clinical trial management, clinical pharmacology, patient access solutions and other enabling services, Fortrea partners with emerging and large biopharma and medical device and diagnostic companies to drive healthcare innovation throughout the world.