Motivating Patients and Maintaining Rigor in Cardiovascular Clinical Trials
Cardiovascular research can feel like a “numbers game” from design and recruitment to analysis. Worldwide brings the experience, decisiveness and tailored solutions your program needs.
Dedicated functional teams, 30 years and counting
Worldwide wins the numbers game. We have more than three decades of experience in cardiovascular and metabolic research, a presence in more than 60 countries, and extensive global trial experience in all phases of research—even involving more than 26,000 patients in a single trial. Yet every single program receives the attention and care of a dedicated functional team, enabling us to act quickly and effectively in close collaboration with key industry partners.
ETERI TSETSKHLADZE, MD, PHD, FESC, FACC
VICE PRESIDENT, GENERAL MEDICINE MEDICAL LEAD, MEDICAL AFFAIRS
As a clinician, investigator, and educator, Dr. Tsetskhladze embodies Worldwide’s commitment to supporting improved health care options. Since joining the Worldwide Clinical Trials team in 2004, she has supported more than 70 studies in her capacity as medical director and therapeutic advisor. She combines scientific and clinical rigor with an intimate understanding of the patient’s experience, and is adept at translating medical and scientific findings into accessible data to serve commercial and regulatory objectives. Dr. Tsetskhladze is a fellow of the American College of Cardiology (ACC) and the European Society of Cardiology (ESC), while also serving on a number of therapeutic working groups. She is credited with more than 50 publications.
KAREN HILL
SENIOR VICE PRESIDENT, PROJECT MANAGEMENT, CARDIOVASCULAR, ENDOCRINE & METABOLIC AND REAL-WORLD EVIDENCE
Karen Hill has served in project management roles with Worldwide and its predecessor companies since 1993. Karen’s experience includes Phase II-IV clinical studies, cardiometabolic outcome and mega-studies, and observational and non-interventional studies. She has overseen monitoring, site management, standard operating procedure (SOP) creation, data management, statistics, CTMS, and trial master file (TMF) compilation, and she is skilled at providing executive oversight for developing, implementing, and adhering to study plans. She enjoys reviewing and improving performance metrics and leading issue resolution.
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.
NANCY NEWARK, RN
Executive Director, Project Management, Cardiovascular
Nancy combines keen attention to clinical rigor with a capacity to oversee global multi-center clinical trials. As franchise lead within Worldwide’s cardiovascular therapeutic area, she provides operational oversight and leadership for our cardiovascular clinical trials, with responsibility for strategic development, regulatory compliance, site management, and clinical monitoring. After more than a decade working as a critical care transport nurse, she provided senior operational leadership for global multi-center clinical trials and registries, including direct responsibility for regulatory compliance, project management, and more at the Duke Clinical Research Institute (DCRI) for 14 years. She has been with Worldwide since 2010.
Extensive cardiovascular outcomes trial and adjudication experience
Our experience executing large cardiovascular trials has resulted in irreplaceable expertise: a solid understanding of the events, treatment, and outcomes of interest. These studies require event adjudication and close collaboration with Clinical Events Committees (CECs).
Cost-effectiveness through smart planning
Smart screening and high compliance rates reduce enrollment costs. Paired with thoughtful statistical analysis plans and early leading signals for rapid identification of struggling products, we offer shorter trials for patients and faster decision-making guidance for sponsors.
A different approach to recruitment & retention
Worldwide can do more than screen patients for inclusion and exclusion criteria. Using emerging predictive analytics technology, we identify the study subjects most likely to comply with the protocol and stay the course of the trial.
Respectful, people-focused study design
Worldwide minimizes attrition and improves statistical validity by anticipating the pain points most likely to cause attrition. We then proactively work to alleviate those concerns, honoring patients’ time and commitment through compressed timelines and reduced study burden.
Cultivating large-scale success stories one patient—and study—at a time
Cardiovascular trials often require teamwide dedication to a broad scope and a patient, detail-oriented operational approach. At Worldwide, we believe each study relies on the commitment of the individuals involved. Find out how this comes through in everything we do.
Cardiovascular Experience
- Acute Coronary Syndrome (ACS)
- Angina
- Anticoagulation
- Atherosclerosis
- Atrial Fibrillation
- Cardiac Arrhythmias
- Coronary Artery Disease (CAD)
- Heart Failure
- Hypertension
- Ischemic Heart Disease
- Myocardial Infarction
- Pulmonary Arterial Hypertension (PAH)
- Restenosis
- Stroke/Cerebrovascular Disease – Prevention
- Thrombosis
Our Dedicated Team
Karen Hill
Senior Vice President, Project Management, Cardiovascular, Endocrine & Metabolic and Real-World Evidence
Soneil Guptha, MD, FACC, FESC, FCCP, AFPM
Senior Medical Director, Medical Affairs, Cardiovascular, Endocrine & Metabolic
Rafal Ziecina, MD, PhD
Executive Director, Scientific Solutions, Cardiovascular, Endocrine & Metabolic
Eteri Tsetskhladze, MD, PhD, FESC, FACC
Vice President, General Medicine Medical Lead, Medical Affairs
