OPTIMIZING OUTCOMES IN NONALCHOHOLIC STEATOHEPATITIS (NASH) 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. Non-alcoholic steatohepatitis (NASH) 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.
EXECUTIVE DIRECTOR, PROJECT MANAGEMENT, NASH
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 NASH/NAFLD 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
With more than 22 years of experience in the World of pharmaceuticals and research, Dr. Ziecina serves as an NAFLD/NASH scientific advisor focused on filing strategies, regulatory and safety strategies. He excels in writing protocols and drug development plans and has extensive experience in study design and medical monitoring for clinical programs.
Is Liver Biopsy a Gold or an Old Standard in NAFL and NASH?
Are you using best practices? Find out if you can drop liver biopsies in this International Biopharmaceutical Industry publication.Learn More
You Have A NASH/NAFLD Study. We Have Your Team
Meet the experts that will make the difference for you—and the resources that will help your program shine.Learn More
A TALE OF TWO AGENCIES: FDA And EMA regulatory guidance for NASH and the impact on program design
Worldwide’s whitepaper identifies the shared objectives of the European Medicines Agency (EMA) and US Food and Drug Administration (FDA) and parses the key points of divergence their respective guidance’s for clinical development in this important therapeutic area.Learn More
Worldwide offers significant global operational expertise and enhanced awareness of the challenges unique to NAFLD/NASH studies. That’s why we employ non-invasive diagnostic measurements, numerous liver imaging modalities, biomarker composite scoring (NAFLD fibrosis score, FIB-4, APRI, Fibrosure/Fibrotest, ELF), and leading pathology techniques whenever possible.
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).
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.
Our extensive experience in NASH/NAFLD 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.
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.
Liver Disease Experience
- Acute Liver Failure
- Alcoholic Hepatitis
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Non-Alcoholic Steatohepatitis (NASH)
- Primary Sclerosing Cholangitis
Our Dedicated Team
Executive Director, Project Management, NASH
Senior Vice President, Project Management, Cardiovascular, Endocrine & Metabolic and Real-World Evidence
Executive Director, Scientific Solutions, Cardiovascular, Endocrine & Metabolic
Global Head of Regulatory Strategy
Senior Medical Director, Medical Affairs, Cardiovascular, Endocrine & Metabolic