Hepatology CRO Services

Therapeutic Expertise Hepatology

The therapeutic area of liver diseases has significant unmet medical need with ailments such as nonalcoholic 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. At PPD, 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 us as your hepatology CRO

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 nonalcoholic 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.

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 PPD study 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 between PPD and 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

PPD works with patient partners throughout the design, operationalization, implementation and dissemination of our studies. We also leverage StudyGage, PPD’s 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, PPD enables customers to accelerate recruitment, cut trial timelines and remove barriers to reach diverse patient populations.

End-to-end liver disease CRO services

With access to the full range of expertise across PPD and 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

Hepatology CRO: Unrivaled Liver Disease Expertise

Why choose us as your hepatology CRO

A wealth of experience and expertise in liver disease research

Our wide-ranging, global experience with liver studies spans

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

Build your clinical research strategy with an experienced partner.

Case studies

Successful enrollment in primary biliary cholangitis clinical trial

Overcoming enrollment challenges in a NASH clinical trial

Faster study startup than industry benchmarks