Where the Rubber Meets the Road: Operational Excellence in Non-Interventional Studies for Regulatory Purpose

About this Session

In part 1 of this webinar series, we covered how to design a non-interventional study that meets regulatory expectations. Part 2 will cover how to run one. Rich Gliklich, Michelle Leavy, and Ombretta Palucci will walk through the operational choices that decide whether a registry holds up under regulatory review, from the technology and data infrastructure behind it to keeping sites and patients engaged for years and running studies across countries.

What We'll Cover

• Technology and data innovations that drive success: how a central site model and data platforms reduce site burden, speed enrollment and strengthen regulatory rigor

• Recruiting the right sites and patients: site selection and activation, and patient recruitment strategies, including how to reach diverse, representative populations

• Keeping sites and patients for the long haul: retention strategies, plus monitoring and reducing loss to follow-up over multi-year studies

• Data extraction and management: planning for data quality from the start, risk-based monitoring, and traceability across data pathways (abstraction from clinical notes, EDC and direct entry, structured data processing)

• Taking it global: practical lessons for running studies across countries, regulators and healthcare systems

Webinar Speakers

Dr. Rich Gliklich, Founder, OM1

Dr. Richard Gliklich, MD is the founder of OM1 and brings decades of experience in the areas of registries, outcomes, and analytics. He is senior editor of the landmark publication by the U.S. Agency for Healthcare Research and Quality (AHRQ) handbook "Registries for Evaluating Patient Outcomes: A User's Guide” and the PI for the Outcomes Measures Framework, which focuses on standardization of outcomes measurement. He has led several key national and international efforts focused on evaluating the safety, effectiveness, value and quality of healthcare. Dr. Gliklich also holds several patents for both health outcomes systems and medical devices.

Michelle Leavy, MPH, Senior Director, Registries, OM1

Michelle Leavy, MPH, is the Senior Director, Registries at OM1, where she oversees prospective observational studies and patient registries as well as projects related to improving patient registry methodology and harmonizing data and outcome measures across patient registries and clinical practice. Michelle was the managing editor of Registries for Evaluating Patient Outcomes: A User’s Guide, and she led a federally funded effort to harmonize outcome measures across registries and clinical care to support depression research. She previously managed efforts to develop harmonized outcome measures for use in patient registries under the Outcome Measures Framework (OMF) project. At OM1, she leads the Registry Center of Excellence, which provides internal and external consulting on observational study best practices. Michelle is a graduate of Columbia College and the UNC Gillings School of Global Public Health. Ms. Leavy is a recognized international expert in registry and longitudinal study design and operations.

Ombretta Palucci, Vice President and Head of Operations, Europe, OM1

Ombretta Palucci is Vice President and Head of Operations, Europe at OM1. Based in Switzerland, she is a pharmaceutical scientist with more than 20 years of leadership in real-world evidence, registries, post-marketing studies, and observational research across Europe. Ombretta brings deep expertise in designing and operationalizing complex registries and has significant experience in global and multi-country studies. Previously, at IQVIA and PAREXEL, she led solution design and delivery for large-scale real-world programs, including oversight of observational studies, pragmatic trials, safety surveillance, and registries. She has extensive experience in global study operations covering regulatory submissions, CRO and vendor management, site activation, patient enrollment, and ethics approvals. She has also managed international teams of up to 100 staff, leading budgets, client engagements, proposal defenses, and business development initiatives. Ombretta holds a Master’s Degree in Pharmaceutical Chemistry and Technology (110/110 cum laude) from the Università degli Studi, Siena, Italy.