Optimizing Outcomes in MASH, MASLD & Other Liver Diseases

We’re committed to the clinical development of therapeutics across all cardiovascular-kidney-metabolic and steatotic liver diseases including metabolic dysfunction-associated steatohepatitis (MASH), metabolic dysfunction-associated steatotic liver disease (MASLD), and other acute and chronic liver diseases.

Focused expertise for your MASH/MASLD & other liver disease programs

As the rate of liver disease continues to rise, so does the challenge of finding the right patients for clinical trials. 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.

Alessandra Vignola

President, Cardiovascular & Metabolic

Alessandra Vignola brings more than 30 years of experience in the pharmaceutical and clinical research industry with therapeutic expertise across several indications, including oncology, hematology, cardiovascular, endocrinology, gastrointestinal, liver, and immunology. At Worldwide, Alessandra leads the Cardiovascular and Metabolic business unit, providing operational and strategic guidance to our teams to drive cardiometabolic program success.

Strong teams with expertise in MASH/MASLD and other liver diseases

You require a true partner that knows the complexities of MASH/MASLD 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.

Extensive experience across CKM

We’ve built a depth of experience in the development of therapeutics for cardiovascular-kidney-metabolic (CKM) diseases. Beyond MASH and MASLD, we specialize in type 2 diabetes, hypertension, obesity, dyslipidemia, and hyperlipidemia. We also support the development of medications to improve metabolic-associated diseases, like GLP-1 agonists.

Disease-specific operations & laboratory services

We employ non-invasive diagnostic measurements, numerous liver imaging modalities, biomarker composite scoring, and leading pathology techniques whenever possible. Our central, bioanalytical, core imaging, and ECG laboratories offer PK/PD and biomarker tests, whole organ volume analysis, hepatic fat fraction, liver stiffness, SAT/VAT fat depot segmentations, and vibration controlled transient elastography +/- controlled attenuation parameter.

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.

Extensive site & KOL relationships

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. We also have access to the leading MASH/MASLD site across the globe, building lasting relationships to support continued enrollment.