ENABLING MEANINGFUL METABOLIC DISEASE RESEARCH
Clear efficacy signals are as crucial as keeping research representative and reasonable in this complex field. Worldwide delivers studies that make sense for everyone
LEVERAGING OUR METABOLIC EXPERTISE
Whether your indication has millions of potential participants across the globe or just dozens, know that Worldwide’s dedicated team and global network of trusted partner sites can offer the expertise you need to succeed. Our extensive group of subject matter experts in both rare and common metabolic conditions help get studies done right.
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.
SONEIL GUPTHA, MD, FACC, FESC, FCCP, AFPM
SENIOR MEDICAL DIRECTOR, MEDICAL AFFAIRS, CARDIOVASCULAR, ENDOCRINE & METABOLIC
With 40 years of experience in clinical development and medical and regulatory affairs, this academician, clinician (interventional cardiologist), and drug and device developer has accumulated valuable experience in the US, Europe, and Asia-Pacific. His areas of extensive expertise include clinical (cardiovascular and metabolic) medicine; pharmaceutical medicine (including drug and device development and more); and research methodologies. Dr. Guptha has a track record of translating organizational strategy into effective medical affairs and clinical development internationally. And operationally, he is experienced in protocol development, outcome trials, clinical trial strategy, filing (IDE, IND, NDA, sNDA), pharmacovigilance, and medical communications. He has published extensively.
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.
MONIKA ITEN, PHD
VICE PRESIDENT PROJECT MANAGEMENT, CARDIOVASCULAR
Monika Iten, PhD, is Vice President of Project Management for Cardiovascular at Worldwide Clinical Trials. With more than 18 years of industry experience in clinical operations, performance management, and marketing, she has overseen the successful execution of large-scale, global clinical trials in cardiovascular and metabolic indications. Dr. Iten’s talent for managing complex teams has had a positive impact on team performance, leading in turn to exceptional delivery of results to our customers.
Worldwide offers broad individual and combined team experience across multiple metabolic indications. No matter the size of your study, you get a dedicated, experienced team.
Worldwide is dedicated to maximizing 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 has a large and growing global network of leading investigators, consultants, key opinion leaders, and medical experts in the fields of endocrinology and metabolic health.
Worldwide offers full-service support to metabolic studies from Phase I, starting with our co-located Clinical Pharmacology Unit and Bioanalytical lab, through post-marketing approval.
Human capital that brings clarity to complexity
At Worldwide, we understand that our greatest strength is our personnel—our expert teams around the world that craft unparalleled design and logistics solutions for even the most challenging studies. When you start with a better CRO team, you get a better study experience for the life of your program.
- Common Disorders
- Chronic Kidney Disease
- Diabetes Type 1/Juvenile
- Diabetes Type 2
- Kidney Disease
- Non-Alcoholic Fatty Liver Disease (NAFLD)
- Non-Alcoholic Steatohepatitis (NASH)
- Rare Endocrine and Metabolic Disorders
- Adrenal Insufficiency
- Congenital Adrenal Hyperplasia
- Fabry Disease
- Familial Chylomicronemia Syndrome
- Fatty Acid Biosynthesis Disorders
- Growth Hormone Deficiency
- Homozygous Familial Hypercholesterolemia
- Lysosomal Storage Disorder
- Niemann-Pick Disease
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