Pioneering treatments in hepatology
As a global contract research organization (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, SC Liver Research Consortium 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
Don’t let site selection and patient recruitment challenges hamper your progress. 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 1,000 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
Regulatory agencies support efforts to expedite the development of drugs that address unmet medical needs like NASH. With different approaches available to reduce your product’s time to marketing approval, our consultants can help you implement the most optimal strategy.
We work with NASH experts to shepherd indications and advise submission processes to meet global, regional and local approvals. 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:
- 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.