Liver Disease CRO
Complex programs, purpose-built team
Ensure success for your next liver disease clinical trial with our expert-led, partnership-based approach that supports complex liver programs at every stage.
Designed Around the Patient
The hardest ask in a liver trial is the one you make of patients
A liver trial asks a lot of the people in it. In MASH, more than 75% of screened patients never reach randomization, most because a baseline biopsy doesn’t confirm fibrotic disease. Those who qualify face repeat biopsies, MRI, and histology-anchored Phase III programs that run 52 weeks or longer. Each step is a place a patient may drop out, and a program may stall. Worldwide designs to reduce that burden: non-invasive enrichment and pre-screening to cut failed biopsies, imaging and biomarker strategies that ease reliance on histology, and retention built to hold patients through long programs.
A Team Dedicated Solely to Liver Disease
Our dedicated team brings scientific depth, site relationships, operational experience, and protocol design insight built through years of focused trial delivery.
One Team Owns Your Endpoint Data
Biopsy collection and reads, biomarker composite scoring, imaging modalities, and central lab coordination are all managed within one scientific team, from first sample through the final pathology read.
Protocol That Stays Ahead of Regulatory Change
Endpoint strategy, fibrosis stratification, biomarker composite scoring, and surrogate endpoint selection go into every protocol from day one, keeping your program aligned with FDA and EMA guidance as it shifts.
Phases, Indications, and Modalities
Specialized Liver Disease CRO Across Phases, Indications & Modalities
Worldwide supports the full spectrum of liver disease, from large-scale metabolic programs to rare and acute indications requiring deep specialist expertise.
- MASH/MASLD
- Cholestatic Liver Disease
- Acute, Rare, & Additional Liver Indications
Services & Capabilities
Full-Service Liver Disease CRO Capabilities
- MASH/MASLD Trial Delivery
- Cholestatic & Rare Liver Disease
- Biomarker & Imaging Integration
- Biopsy Management
- Acute & Complex Liver Programs
- Global Site Network Access
- Regulatory & Endpoint Strategy
- Metabolic-Liver Program Integration
MASH / MASLD Trial Delivery
Phase I through III MASH and MASLD programs, with site strategy, biopsy management, biomarker integration, and endpoint support
Cholestatic & Rare Liver Disease
PSC, PBC, autoimmune hepatitis, and additional rare cholestatic indications, with specialist site access, KOL engagement, and adaptive trial design for small patient populations
Biomarker & Imaging Integration
Biomarker frameworks and imaging modalities, including MRI-PDFF, Fibroscan, and central lab coordination, managed across sites under one scientific team
Biopsy Management
Biopsy collection, processing, and central reads managed within the liver team for consistency and data quality
Acute & Complex Liver Programs
Global Phase II programs across acute liver failure, ACLF, cirrhosis, alcoholic hepatitis, and DILI
Why Worldwide for Liver Disease Trials
The Access, Expertise, & Flexibility Your Program Needs
700+ Globally Experienced Liver Sites
Direct access to high-performing liver sites means faster activation and stronger recruitment across complex and rare indications.
Recognized Scientific Leadership in Liver Disease
Our liver team’s published thought leadership and KOL relationships reflect scientific credibility that goes beyond operational delivery.
Full-Service, FSP, & Hybrid Delivery Options
Whether you need end-to-end trial management or targeted functional support, one dedicated team stays consistent throughout.
Specialized Liver Disease Clinical Research Leadership
Expertise Built Over Decades
Worldwide’s liver team brings deep scientific and operational experience across every major liver indication and phase of clinical development.
Attila Timar-Peregrin, MD, PhD
Executive Director, Medical Affairs & Therapeutic Area Lead, Digestive Diseases
Partnership & Approach
Your Program, Supported by One Dedicated Team
At Worldwide, you work directly with liver-experienced medical directors, senior project managers, and scientific leaders who bring continuity, specialized insight, and hands-on partnership from first conversation through final analysis.
A Track Record Built on Liver-Specific Experience
Worldwide has delivered liver programs at every scale, from rare indication Phase II through global Phase III MASH biopsy programs.
4.5
Months Ahead of Schedule
Phase II PSC enrollment milestone delivered across 65+ sites in 11 countries — supporting positive topline results
700+
Globally Experienced
Liver Sites
150+
Routine
Partnerships
Direct access to high-performing investigators and proven liver
trial sites
5,000+
Patients Across
30+
Countries
Execution at scale across complex, multi-country liver trials
Frequently Asked Questions
Your Questions Answered
We have answered the questions sponsors ask most often. If yours isn’t here, our liver team is happy to help.
MASH and MASLD are the core, with Phase I through Phase III delivery. Rare and cholestatic coverage includes PBC, PSC, autoimmune hepatitis, PFIC, Alagille syndrome, biliary atresia, alpha-1 antitrypsin deficiency, and Wilson disease. On the acute side: acute liver failure, ACLF, alcoholic hepatitis, cirrhosis, HCC, and DILI. If it involves the liver, we have likely been there.
700+ sites globally experienced in liver disease studies, with 150+ routinely partnered high-performing liver sites across 30+ countries. These are ongoing relationships, not cold contacts, which matters when you need fast activation on a rare indication or a compressed timeline.
MASH Phase III: 668 subjects across 150 sites. Phase II: 151 patients across 120 sites, 89 patients across 15 sites, and 69 patients across 20 sites. Phase I: 112 patients in one early phase unit, 67 patients in one Early Phase Unit. All programs incorporate biopsy management, MRI-PDFF, Fibroscan, and biomarker composite scoring.
Our team tracks FDA and EMA guidance closely, including the FDA acceptance of FibroScan LSM as a reasonably likely surrogate endpoint and the F2/F3 vs. F4 stratification picture following the semaglutide approval. Surrogate endpoint strategy and biomarker composite scoring go into protocol design from the start.
PSC Phase II: 110+ patients across 65+ sites in 11 countries, with the enrollment milestone met four and a half months early. PBC Phase I: 18 patients in an early phase unit. Acute Liver Failure Phase II: 250 subjects across 35 sites globally. Our KOL relationships, PAG connections, and specialist sites are built over time, so when your program needs them, they are ready.
Biopsy collection, processing, and reads are delivered inside our liver team, not outsourced. Imaging (i.e., MRI-PDFF, MRE, and Fibroscan) and biomarker composite scoring (i.e., MASH, fibrosis score, FIB-4, APRI, FirborSURE/FibroTest, and ELF) are integrated under the same scientific leadership.
The liver and metabolic franchises sit inside one business unit, with scientific leaders who work together as one team. Cross-franchise programs, including obesity-into-MASH, GLP-1 combination and MASH, and whole-body obesity, receive integrated scientific input from day one.
Worldwide maintains strong relationships with leading liver KOLs and scientific experts. The team’s thought leadership includes the Pitfalls and Best Practices: Clinical Trial Design in MASH infographic, co-authored by Peyton Sandroni, MarieElena Cordisco, Attila Timar-Peregrin, and Michael Murphy.
