Hepatology CRO Services

Therapeutic Expertise Hepatology

The therapeutic area of liver diseases has significant unmet medical need with ailments such as non-alcoholic steatohepatitis (NASH), alpha 1-antitrypsin deficiency (A1ATD), primary biliary cholangitis (PBC) and primary sclerosing cholangitis (PSC).

In NASH, despite a large patient population, there is not an approved disease-specific drug therapy. Prevalence of NASH alone is expected to increase 63% by 2030 and is projected to become the leading indication for liver transplants.

Liver disease clinical studies face considerable challenges, including:

High screen-fail rates
Lack of investigator familiarity with the disease
Patient safety
Training for new sites
Patient recruitment
Patient diversity, in particular for NASH studies
Vendor selection and management

Drug developers tackling complex liver diseases need an experienced contract research organization as their hepatology CRO. We apply the expansive global footprint, development capabilities and expertise we’ve built in clinical drug studies to accelerate your liver drug development program.

Accelerate your hepatology clinical trial

Incorporating the patient’s voice in NASH clinical trials

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Why choose our hepatology CRO solutions

Chronic liver disease is growing in prevalence and contributes to rising rates of cirrhosis, liver failure and liver cancer. Meanwhile, mortality rates for alcoholic-associated liver disease and non-alcoholic fatty liver disease (NAFLD) substantially increased during the COVID-19 pandemic.

The imperative to rapidly deliver a treatment for liver diseases calls for a clinical research strategy built around experience, speed and global reach.

A wealth of experience and expertise in liver disease research

As a complement to our broad experience in gastroenterology, we have demonstrated expertise in the evolving hepatology clinical trials landscape.

Our wide-ranging, global experience with liver studies spans

liver disease studies

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patients

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active sites

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countries

Our experts have led clinical research across a range of liver indications, including:

Alpha 1-antitrypsin deficiency
Non-alcoholic fatty liver disease (NAFLD)
Non-alcoholic steatohepatitis (NASH)
Primary biliary cholangitis (PBC)
Primary sclerosing cholangitis (PSC)

Build your clinical research strategy with an experienced partner.

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Case studies

Successful enrollment in primary biliary cholangitis clinical trial

Background: A client faced enrollment challenges when conducting a Phase III primary biliary cholangitis study that required optional liver biopsy, FibroScan, and eDiary for Pruritus and QoL scales.

Challenges: With a rare disease like PBC, the sponsor faced a number of challenges, including:

50% Screen-fail rate
Difficulty identifying the right patients
Slow start up

Outcomes: By partnering with us, the client met the deadline for last patient in by:

Engaging with the sites with face-to-face meetings
Implementing slot management via ePIP
Creating a knowledge sharing community

Overcoming enrollment challenges in a NASH clinical trial

Background: A client pursuing a Phase IIa NASH study experienced enrollment difficulties. Key study procedures included FibroScan and noninvasive biomarkers for primary endpoint assessment.

Challenges:

Significant delays in site activations in two EU countries.
10% increase in enrolled patients was implemented at the trial’s midpoint
Higher than planned screen-fail rate
Loss of Ukraine’s participation

Outcomes: By partnering with us, the client engaged with sites and developed a strategic enrollment plan, which achieved:

Last patient in within 10 months of first site activation, keeping enrollment on time with a 10% increase in patients
Dropout rate 5% (nine patients discontinued)
Non-enrolling sites 4.3%

Faster study startup than industry benchmarks

Over the past five years, we have consistently exceeded study startup industry benchmarks in liver diseases.

Our median cycle times for liver studies are up to:

30% faster than benchmark for final protocol received to 50% of sites activated
10% faster than benchmark for final protocol received to first subject screened
20% faster than benchmark for final protocol received to 50% of subjects enrolled

Our customers benefit from our investments in people, process improvement and technology implementation to drive quicker startup for their clinical trials.

Patient centricity that accelerates your clinical hepatology trials

Your needs and goals become ours, and nowhere is that more apparent than in our investment in the patient. Our expertise enables sponsors to develop a study-specific patient engagement strategy and integrate patient insights into key study decisions.

Our patient-first approach enables our customers to

Engage better with diverse communities

A diversity plan for NASH trials begins with understanding the impacted patient population and driving inclusive clinical development, particularly within Hispanic communities. Each of our studies includes a Patient Diversity Team that provides strategic counsel and materials for study teams to optimize trial design/start-up, enrollment, and retention of diverse populations.

Elevate patient outreach and education with patient advocacy groups (PAGs)

PAGs, when coordinated and approved by the sponsor, play an important role in patient outreach, starting with advertising and sharing knowledge about studies on the PAG’s website. Dedicated discussions with a PAG inform and entice the target patients, enabling sponsors to accelerate recruitment.

Improve patient engagement, recruitment and retention

Retention success begins with site investment, including investing in coordinator knowledge, which increases the participant’s confidence in their health care team. By building patient confidence in the trial coordinator, we strengthen patient trust and better the likelihood of retention.

Optimize all stages of study delivery based on the patient perspective

We work with patient partners throughout the design, operationalization, implementation and dissemination of our studies. We also leverage StudyGage, our proprietary preference-data-based tool, which simulates participation rates in clinical studies. This enables our customers to elevate their studies by:
- Aligning your recruitment and diversity strategies around a clear understanding of the patient pathway
- Testing and optimizing your operational strategies
- Ensuring your patient-facing materials are accessible and impactful

Make trials more accessible

By implementing digital and decentralized trial solutions, we enable our customers to accelerate recruitment, cut trial timelines and remove barriers to reach diverse patient populations.

Comprehensive, global site recruitment plan

Our integrated approach to site planning and collaboration enhances enrollment and retention in highly competitive areas. Our customers benefit from our:

Expansive network of sites around the globe. Sponsors gain access to sites and patients in new regions, including in Hispanic communities where NASH is prevalent, thanks to our reliable and expanding network of sites.
Strong relationships with key sites and investigators. Our customers meet or surpass their study milestones when we build a site plan that levies our years of experience managing clinical trials around the world.
Collaborative study planning. From site initiation through the final visit, we work closely with the site to create a customized recruitment plan, identifying the necessary patient recruitment materials, reviewing the pre-screening and screening processes, and formalizing the site’s approach and goals.

End-to-end liver disease CRO services

With access to the full range of expertise across Thermo Fisher Scientific, our customers are better able to navigate risk across:

Research and discovery: Scientific technologies to enable a faster start and a deep understanding of the medical requirements
Process development and optimization: Solutions and technologies to fine-tune the science, advance the strongest candidates and design clinical trials
Pre-clinical: Laboratory support and other analytical analyses models to determine if a drug candidate is safe to test in humans
Clinical trials: Full-service clinical research capabilities coupled with asset, logistics, and regulatory management to navigate drug development and prove efficacy
Commercialization and production: Market access, regulatory expertise, supply chain management, manufacturing solutions, and distribution to get to market faster and drive more value
Rare and pediatric expertise: Shape trial design, strategy, and delivery for adult and pediatric rare indications with the PPD™ Rare Disease and Pediatrics Center of Excellence
Routine and specialty testing: Central Lab services offer a full complement of solutions including routine testing, biopsy sample management and logistics, and pathology
Automated data flow for patient and biopsy tracking: A clear pathway that leverages internal resources, mitigates tracking challenges and increases efficiency