Risk-Based Monitoring in Clinical Trials: Improve Oversight Through Intelligent Review of Digital Endpoint Data

Todd Rudo, MD, EVP, Chief Medical Officer, 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.

Stacey Rumerman, PsyD, VP Clinical Science, eCOA Neuroscience, 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, MD, Senior Cardiologist, Cardiology, Clario

Alain Gay, MD, is board-certified in Cardiology. After completing his training as a Cardiologist at the Hopital 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, 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.