Optimizing Outcomes in Metabolic Dysfunction-Associated Steatohepatitis (MASH) And Liver Diseases

Uncertainty and risk are inherent to the world of clinical research. Worldwide uses the latest hepatic imaging, diagnostic technology, and analytic techniques to maximize convenience and minimize risk—for patients and sponsors.

Focused expertise for your liver disease programs

As the rate of liver disease continues to rise, so does the challenge of finding the right patients for clinical trials. Metabolic dysfunction-associated steatohepatitis (MASH) has few detectable symptoms in its early stages, leading to progressive and more serious disease stages, including cirrhosis, liver failure, liver cancer, and cardiovascular events. To get your investigative medicinal product all the way to market faster to help patients sooner, partner with our experienced team at Worldwide Clinical Trials.

Scott Beasley

Executive Director, Project Management, MASH

Scott’s experience includes project management, clinical team management, portfolio development, and training across all phases of development, including compassionate use programs. He has more than 24 years of experience in the industry, with extensive MASH/MASLD experience in Phase II and several Phase III programs. His proven leadership and strategic protocol and operational expertise ensure successful implementation and delivery for his projects.

Rafal Ziecina, MD, PhD

Executive Director, Scientific Solutions, Cardiovascular, Endocrine & Metabolic

Rafal Ziecina, MD, PhD, Executive Director of Scientific Solutions at Worldwide Clinical Trials, has built his expertise over more than two decades working in pharmaceutical companies and research organizations. At Worldwide Clinical Trials, he provides scientific and medical leadership of cardiovascular and metabolic research initiatives. For sponsors, Dr. Ziecina provides strategic service around filing, regulatory, and safety, as well as writing services for protocol and drug development plans.

Strong teams with expertise in liver diseases

You require a true partner that knows the complexities of liver disease trials and has the global expertise to get your product to market. Our award-winning approach combines patient centricity with strong investigative collaboration to arrive at optimal strategies for achieving reliable data on time and within budget.

Disease-specific operations and assessment experience

Worldwide offers significant global operational expertise and enhanced awareness of the challenges unique to MASLD/MASH studies. That’s why we employ non-invasive diagnostic measurements, numerous liver imaging modalities, biomarker composite scoring (MASLD fibrosis score, FIB-4, APRI, Fibrosure/Fibrotest, ELF), and leading pathology techniques whenever possible.

Core imaging labs and central laboratory services for improved diagnostics

Our clinical trials endeavor to maximize clinical information while minimizing patient discomfort and safety concerns. That’s why our central, bioanalytical, core imaging, and ECG laboratories offer PK/PD and biomarker tests, whole organ volume analysis (liver and spleen), hepatic fat fraction (MRI-PDFF), liver stiffness (MR elastography), SAT/VAT fat depot segmentation, and vibration controlled transient elastography (VCTE) +/- controlled attenuation parameter (CAP).

Regulatory expertise, across the globe

Worldwide offers up-to-date regulatory intelligence via in-country expertise for global trials, engaging with regulatory agencies and taking advantage of pre-submission meetings or expedited pathways whenever possible to ease the way toward market approval. Our experts can also provide assistance with biomarker qualification programs, guidance for critical path innovation meetings, and pediatric-specific strategic consulting and submissions.

An extensive KOL network

Our extensive experience in MASH/MASLD research has helped us build a tried-and-true group of trusted subject matter experts and key opinion leaders who infuse our study designs with the latest clinical insights, improving patient and investigator experience as well as market uptake.

Liver Disease Experience

  • Acute Liver Failure
  • Alcoholic Hepatitis
  • Metabolic dysfunction-associated steatotic liver disease (MASLD)
  • Metabolic dysfunction-associated steatohepatitis (MASH)
  • Primary Sclerosing Cholangitis