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.
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
What will you learn:
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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:
施設選択や患者様のリクルートで、進行に支障が出るようなことがあってはなりません。 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.
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.
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.
NASH などの医療分野で医薬品開発をスピードアップする取り組みは、満たされていないニーズへの対策となるため、規制当局からも支持されています。 With different approaches available to reduce your product's time to marketing approval, our consultants can help you implement the most optimal strategy.
当社では、世界、地域、国内それぞれで承認が獲得できるよう NASH の専門家と協力しながら適応症を管理し、申請の提案を行っています。 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.
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.
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 ドル-5 000 ドル 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 NASHnextTM, 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.
Address the urgent unmet need for NAFLD and NASH treatments with our unique combination of cross-functional expertise and programmatic experience.
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