Non-Alcoholic Steatohepatitis (NASH) Liver Disease Drug Development Solutions
Address the urgent unmet need for NASH liver disease treatments with our unique combination of cross-functional expertise and programmatic experience.
Proven Expertise Accelerates NASH Drug Development.
Recruit and retain key patients with smarter site selection
Rely on strong experience with liver biopsies, biomarkers, novel imaging techniques and long-term outcome studies
Access comprehensive medical, scientific and regulatory support across your NASH program
Addressing NASH challenges from end to end.
Meeting today’s unmet needs in NASH (Non-Alcoholic Steatohepatitis) treatment requires more than an ideal drug candidate to reach the market. Accelerating your NASH program demands specialized support that encompasses several key success factors:
- Forming a strategic clinical development plan
- Designing a customized protocol
- Finding specialized sites to work with liver biopsy, imaging and biomarker needs
Let Covance help you execute a comprehensive strategy that addresses the unique challenges of NASH and meets your requirements—at every stage of development.
Motivated investigators. Engaged patients.
Don’t let site selection and patient recruitment challenges hamper your progress. We can keep your NASH drug development timeline on track through site-specific recruitment plans, drawing on our strong network of referral network, key opinion leaders and patient advocacy groups.
With our proprietary Xcellerate® Informatics Platform, including the industry’s largest clinical knowledgebase and outreach across more than 600 global sites across 26 countries, we’ll help you find the right locations for your trial to reach your rapid study start-up goals and employ ongoing initiatives that proactively manage patient retention.
A proven global partner.
NASH holds many uncertainties in its diagnosis, evaluation, management and progression, but one thing is certain: a dedicated partner with relevant NASH experience can increase your chance of tackling this disease.
Count on our global history of trials in Type 2 Diabetes, Obesity and Lipids, along with expertise in liver biopsy, novel biomarkers, imaging methods and adjudication for outcomes trials to deliver valuable insights across your program. Together, we can create new possibilities for your NASH study and forge a path for more thoughtful, efficient development.
Your near-term goals. Our long-term commitment.
NASH represents a rapidly developing field with several potential therapeutic options in the pipeline and many more on the horizon, yet none have made it to market. At Covance, we recognized this opportunity to harness our regulatory, medical, scientific and operational expertise and transform results in the field.
Our investment started with active participation with the NASH scientific community, the Liver Forum and other diabetes-related professional associations to understand the needs of sponsors from multiple perspectives. We’re ready to meet your near-term NASH goals as part of our ongoing commitment to change the outlook and make a difference to sponsors and patients.
Illuminating your regulatory pathway.
Regulatory agencies support efforts to expedite the development of drugs that address unmet medical needs, like NASH. With many different approaches to reduce your product’s time to marketing approval, rely on our expertise to help you choose and incorporate the most optimal strategy.
We work with NASH experts to shepherd indications and advise submissions 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—and create the maximum value for your novel NASH product.
Delivering insights. Applying experience.
As a global CRO that supports novel development with hundreds of sponsors each year, we know how to advance compounds to the clinic and the market. NASH development 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 start-up timelines and retain patients
- Support global testing and biomarker development
- Leverage advanced informatics tools and employ electronic data collection forms
With our medical and regulatory team solely devoted to NASH, deep scientific experience and key operational solutions to overcome development hurdles, we’ll help you make an impact in this competitive landscape.
We know NASH and what it takes to get ahead. Now, get to know us to discuss how we can reveal new opportunities for your critical studies.