Marlys Chellew is a seasoned Clinical Research professional with over 29 years of extensive experience in managing FDA-regulated trials across a diverse array of therapeutic areas. Currently, she plays a pivotal role at Zenflow, Inc. as a member of the Data Safety Monitoring Committee (DSMC)...
Marlys Chellew is a seasoned Clinical Research professional with over 29 years of extensive experience in managing FDA-regulated trials across a diverse array of therapeutic areas. Currently, she plays a pivotal role at Zenflow, Inc. as a member of the Data Safety Monitoring Committee (DSMC) for a pivotal Benign Prostatic Hyperplasia (BPH) Investigational Device Exemption (IDE) study. In this capacity, Marlys is responsible for the setup and management of a remote DSMC, ensuring that the trial adheres to the highest standards of safety and regulatory compliance. Her expertise is instrumental in the development of the DSMC Charter and associated materials, which she crafts in close collaboration with the study sponsor.
Marlys’s extensive background in clinical trials encompasses a wide range of skills, including interventional cardiology, vascular surgery, and cardiac surgery, making her a valuable asset in the clinical research organization (CRO) landscape. Her proficiency in regulatory affairs and the establishment of Standard Operating Procedures (SOPs) ensures that all trial activities are conducted in accordance with FDA regulations and industry best practices.
Throughout her career, Marlys has demonstrated a proven track record in the development and execution of First-In-Man (FIM), IDE, and post-market clinical research trials. Her results-oriented approach and commitment to patient safety have not only contributed to the successful management of complex clinical studies but have also fostered a culture of transparency and ethical oversight within the clinical research community. As she continues to navigate the evolving landscape of clinical research at Zenflow, Inc., Marlys remains dedicated to advancing innovative therapies while prioritizing the safety and well-being of trial participants.
