Clinical Studies in Hepatology

Solving today’s greatest challenges in liver disease clinical trials requires a partner with the unique scientific data, medical expertise and operational experience to make a difference.

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Data-driven strategy with smarter site selection and patient recruitment to optimize hepatology studies

Rely on strong experience with liver biopsies, protocol design and writing, liver imaging techniques, biomarkers and novel recruitment approaches

Access comprehensive medical, scientific and regulatory support to empower your clinical trials for liver disease

Investigating the Role for Non Invasive Tools (NITs) in Non Alcoholic Steatohepatitis NASH

What will you learn:

Lessons from NIMBLE (Non-Invasive Biomarkers of Metabolic Liver Disease) consortium and published Data for NIT in NASH
Evaluation of NITs in light of intended use
Sensitivity and specificity of NITs reviewed
How NIS4 is positioned
How to adequately stratify patients for treatment intervention or clinical trial enrollment

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Une médecine de précision contre la NASH

What will you learn:

Findings of NASH research and why there is a need for personalized medicine
The advantages and potential challenges of personalized medicine in NASH
Genetic NAFLD as one of the potential personalized approaches
Challenges associated with the precision medicine approach in NASH trials and the proposed solutions

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Pioneering treatments in hepatology

As a global CRO that supports novel development with hundreds of sponsors each year, we know how to efficiently advance compounds to the clinic and the market. 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 or more years of drug development experience
In-house medical and operational expertise in all facets of hepatic trials
Strong connections to key opinion leaders, networks including Summit, ObjectiveHealth, SCLRC and others, advocacy groups such as the Global Liver Institute, and top investigators across the globe
A large portfolio of liver disease trials, including nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH), cirrhosis, cholestatic liver diseases and other chronic and acute liver indications
Proven patient recruitment and retention tactics supporting liver disease clinical trials
Success as the only CRO to have delivered Subpart H in two NASH trials

Motivated investigators, engaged patients

Ne laissez pas les exigences de sélection de sites et de recrutement des patients ralentir votre progression. We can keep your hepatology drug development timeline on track through site-specific recruitment plans, drawing on our strong network and site relationships and directly interacting with key opinion leaders and patient advocacy groups.

With Global Trial Source and our proprietary Xcellerate^® Informatics Platform, we’re well-equipped to help you identify target population hot spots and ideal trial locations to reach rapid study startup goals.

Clinical knowledge base and site-specific recruitment metrics across more than 1000 global principal investigators in 50 countries
Proprietary Spotfire® dashboard of more than 20 studies for cross-trial investigator performance and selection of the most consistent performing sites
Direct access to 150 million Labcorp patients in the U.S. to identify patient hot spots and support recruitment
Global Voice of the Patient data across more than 20 indications to apply best practices that improve protocol design

Need help employing new initiatives that proactively manage patient retention? Discover flexible solutions in our decentralized clinical trial approaches to minimize patient and site burden.

A proven, global partner in NASH clinical trials

Notoriously difficult to diagnose and enroll, NASH trials face many challenges. Our experience with patient engagement in long-term trials and optimal site selection can help minimize common problems that impede a study's progress, such as screen failures or missed cases.

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

Navigating your regulatory pathway

Les agences réglementaires s'efforcent d'accélérer le développement de médicaments répondant à des besoins médicaux non pourvus, comme la stéatohépatite non alcoolique (SHNA). With different approaches available to reduce your product's time to marketing approval, our consultants can help you implement the most optimal strategy.

Nous travaillons avec des experts SHNA pour respecter les indications et émettre des avis afin de répondre aux exigences mondiales, régionales ou locales. Building off our foundation of strategic preclinical and clinical trial methodologies, we can fully support your approval process-creating the maximum value for your novel NASH product.

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:

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

Enhancing liver disease therapeutics with precision medicine drug development

Nearly one-third of U.S. adults and nearly one-quarter of adults worldwide are thought to have NAFLD, a liver condition that's often difficult to identify. NASH, the most severe form of NAFLD, can be asymptomatic or present symptoms similar to those found in other diseases, further complicating an accurate diagnosis.

While liver biopsies have been a standard practice of clinical trials for liver disease, they come with many drawbacks. Besides being invasive, uncomfortable and risky for patients, liver biopsies are also expensive for investigators-costing an estimated 3 000 $-5 000 $ per patient. When considering how best to strengthen patient recruitment and retention for these types of trials, it is evident noninvasive testing is needed.

Inherent variability in both the presentation of NASH, as well as NASH progression, has further complicated the identification and approval of new medicines for this widespread disease. It appears increasingly likely that a variety of disease interventions, used singly or in combination, will be needed to fully address NASH medical need. This is likewise the case for liver diseases that share some pathophysiological features of NASH, like primary sclerosing cholangitis (PSC) and primary biliary cholangitis (PBC).

At Labcorp, we’re exploring new pathways for precision medicines in hepatology so patients receive quality treatment sooner. Using blood-based diagnostic tests such as NASHnext^TM, we’re able to measure NASH biomarkers in a noninvasive way to yield an NIS4 score that identifies at-risk NASH populations. Using this test avoids unnecessary biopsy screening in a larger population and the test itself is significantly less expensive and safer for patients. We have also implemented the newly approved prognostic, Enhanced Liver Fibrosis (ELF) Test, to further support patient disease staging. New genotyping offerings enabling the detection of risk alleles in liver disease genes including PNPLA3 and HSD17B13 will help identify patients at risk for more rapid disease progression.

Learn more about our NASH biomarkers and companion diagnosics.