HELPING DELIVER BETTER HEALTH OUTCOMES FOR LIVER DISEASES INCLUDING NASH, CHOLESTATIC LIVER DISEASES, ALCOHOLIC HEPATITIS, ACUTE-ON-CHRONIC LIVER FAILURE AND CIRRHOSIS

Hepatology

Rich database of site-specific recruitment performance to optimize site selection and deliver patient recruitment.

Extensive operational experience with complex liver study designs involving liver biopsy, imaging techniques and rare disease populations to mitigate risks.

Comprehensive medical, scientific and regulatory expertise to empower your clinical trials for success.

Advancing treatments in hepatology.

Our extensive enterprise-wide expertise in liver diseases, supported by therapeutic area experts in medical, regulatory, strategy and operations, allows us to tailor solutions to meet your liver drug development needs. Access unique insights from our unparalleled liver data to support your protocol and clinical plan design and deliver better outcomes for patients. Our leading experience and capabilities in the liver disease therapeutic area include:

  • A dedicated team of liver disease experts – each with 20 plus years of experience – to provide guidance on protocol design, screening paradigms, regulatory strategy and operational strategy
  • Strong relationships with KOLs, sites and NASH networks to drive study uptake, expedite start-up and support patient recruitment
  • A large portfolio of liver disease trials, including:
    • Non-alcoholic fatty liver disease (NAFLD)
    • Non-alcoholic steatohepatitis (NASH)
    • Cirrhosis
    • Cholestatic liver diseases
    • Acute liver indications
  • Clinical knowledge base and site-specific recruitment metrics across more than 1000 global hepatology investigators in 50 countries
  • Proprietary dashboard of more than 20 NASH studies for cross-trial investigator performance to select the consistently high-performing sites
  • Global site-specific recruitment data in cholestatic disease to target the best recruiting sites
  • Forward-facing innovative technology to ensure patient-centric solutions

A proven partner in liver disease clinical trials.

Hepatology trials face many challenges including low diagnosis rate, high screen fail rates, low recruitment rates and rare disease populations. Our experience with protocol design, strategic study design and optimal site selection helps to minimize common problems that impede a study’s progress, such as screen failures or missed cases.

Fortrea is continuously learning and improving its approaches. As a dedicated partner with relevant and deep hepatology experience, we are ready to help you successfully design and deliver your liver disease clinical trial with proven solutions and innovative new approaches.

Delivering valuable insights through applied experience.

We help you execute a comprehensive strategy that addresses the unique hepatology drug development challenges and is tailored to meet your requirements. Clinical development in hepatology relies on proven processes, along with additional strategies to:

  • Apply adaptive trial designs to improve study efficiency and advance your program
  • Incorporate specialized operational experience with novel imaging methods and coordinated interpretation of liver biopsies
  • Identify and manage risks with risk-based monitoring
  • Meet rapid study startup timelines and retain patients
  • Deploy decentralized trial solutions to engage patients better
  • Support global testing and NASH biomarker development
  • Leverage advanced informatics tools to support recruitment


Partner with us to see how we can uncover new opportunities for your critical liver disease research and clinical trials.

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