Risk-Based Monitoring in Clinical Trials: Improve Oversight Through Intelligent Review of Digital Endpoint Data
The session will break down the key elements that contribute to trial risk and discuss how a centralized, data-driven approach can enhance signal detection, reduce variability and potentially lower overall clinical trial risk without increasing operational burden.
Register for this webinar to learn how Risk-Based Monitoring can strengthen clinical trial oversight through intelligent review of digital endpoint data.
Session information:
Time:
- 11:00 a.m. – 12:00 p.m. EDT (NA-East)
- 04:00 p.m. – 05:00 p.m. BST (UK)
- 05:00 p.m. – 06:00 p.m. CEST (EU-Central)
Register for this webinar to learn how Risk-Based Monitoring can strengthen clinical trial oversight through intelligent review of digital endpoint data.
Attendees will:
- Understand key elements to reduce risk for clinical trials
- Learn how Independent Review and Data Analytics in eCOA strengthen endpoint integrity and proactively minimize risk
- Discover how AI-supported and expert-validated data monitoring can proactively monitor Spirometry and ECG data through real-world examples
- Learn how to integrate these tools into overall risk-based monitoring strategies
Moderator
Todd Rudo, M.D.
EVP, Chief Medical Officer at Clario
Dr. Todd Rudo is EVP and Chief Medical Officer at Clario, providing medical and scientific leadership across the organization. He has nearly 20 years of clinical cardiology and pharmaceutical research experience, with a career predominantly focused on drug safety.
Dr. Rudo has board certifications in cardiology, cardiac electrophysiology, nuclear cardiology, adult echocardiography and internal medicine. His team provides expert consulting to clients on scientific and regulatory strategy, and ensures Clario’s product portfolio is scientifically robust, generating high-quality clinical trial endpoint data. Dr. Rudo has a particular interest in applying innovative technologies to improve the scientific rigor of clinical trials, while maintaining focus on the customer experience, including minimizing patient and site burden.
Speakers
Stacey Rumerman, PsyD
VP Clinical Science, eCOA Neuroscience at Clario
Dr. Stacey Rumerman is a Clinical Psychologist with over 20 years of clinical experience and more than a decade in clinical research, primarily focused on CNS disorders. She provides strategic clinical and scientific leadership to global teams, with expertise in rater training, clinical endpoint protection, data analytics and eCOA implementation. Her oversight spans Psychiatry and Neurology programs, including depression, bipolar disorder, schizophrenia, Alzheimer’s disease and Parkinson’s disease, across inpatient, outpatient and research settings.
Alain Gay, M.D.
Senior Cardiologist, Cardiology at Clario
Alain Gay, M.D., is board-certified in Cardiology. After completing his training as a Cardiologist at the Hospital Cardiologique in Lille, France, Dr. Gay practiced for 10 years in a community hospital, completing his training in Cardiac Electrophysiology and Cardiac Pacing.
Dr. Gay then moved into Drug Development and Medical Affairs studies for 15 years at Bayer. He contributed to establishing study standards in heart failure and contributed to the prelaunch and launch of both Xarelto® and Kerendia®.
At Clario, Dr. Gay is a contributor to the ECG core lab and also reads Holters and other recordings. He works with our global customers to ensure their needs are met with robust, cost-effective solutions.
Kevin McCarthy, RPFT, ATSF, FAARC
Senior Director, Scientific Affairs, Respiratory Science at Clario
Kevin McCarthy has worked in lung function testing for 50+ years, with 40 years as the Manager of the Pulmonary Function Laboratories at the Cleveland Clinic Health System. He has always been passionate about the quality of pulmonary function measurements and has moved this passion to the clinical trial world, where data quality is critical and where these measurements help accurately answer the questions we are asking.
Kevin’s research experience includes managing pulmonary function quality control in two NIH-funded registries: patients with severe A1AT deficiency and the Registry of patients with lymphangioleiomyomatosis (LAM). He has published extensively on pulmonary function testing and is a former member of the ATS PFT Committee and ATS/ERS Task Forces that updated the standards for Spirometry in 2019 and the standards for Lung Volume testing in 2023.