Strategies to Avoid Enrollment Delays
Completing enrollment is typically one of the most critical milestones in a clinical trial. Enrollment delays impact the study budget, site resources, and downstream timelines. Therefore, it is important to identify potential risks to enrollment early in the study, even during the protocol development process if possible. Defining risk mitigation strategies and setting quality tolerance limits allows the study team to quickly identify when a strategy must be implemented to keep enrollment on track. In this webinar, we will discuss how we have used a risk-based quality management system to document enrollment risks and creative solutions we have implemented.
Senior Project Manager
A pain expert at Rho, Ms. Baggett has over 14 years of clinical trial experience. In the last 8 years alone, she has led 3 chronic pain studies and 7 acute pain studies across 5 programs. This success is partly due to her keen understanding of the unique challenges inherent to chronic and acute pain studies such as accurate pain reporting for efficacy endpoints, operational challenges resulting from swift enrollment on elective surgical models for acute pain, and subject retention challenges for single-injection chronic pain studies. In 2017, Ms. Baggett earned her Regulatory Affairs Certification (RAC) which provides her with…
Senior Director, Project Management
Brandy Lind, PMP, RAC served as Program Director for the Medical Countermeasures Clinical Studies Network (MCM-CSN) contract funded by the Office of the Assistant Secretary for Preparedness and Response (ASPR), Biomedical and Advanced Research Development Authority (BARDA). She is currently a Senior Director of Project Management and has been at Rho for over 15 years. As the BARDA Program Director, Ms. Lind was responsible for managing a cross-functional team and ensuring consistency in communication and processes across the projects. She has also been involved in proposal development efforts for the 2 MCM-CSN base contracts and the individual task orders, leading…
Nancy Yovetich, Ph.D.
Principal Research Scientist
Dr. Nancy Yovetich is a Principal Research Scientist who has been involved in the research of psychiatric, neurologic and analgesic therapies for more than 25 years. Her responsibilities have included study design, protocol writing, project and clinical study management, data management, analysis and report writing. A frequently-cited author, Dr. Yovetich has written scientific and medical articles in the related areas of the aging process, the dually-diagnosed homeless population (substance abuse and psychiatric illness), and pediatric patients with sickle cell disease and prior stroke. Her specific indication experience includes Alzheimer’s disease (2 studies), traumatic brain injury (3 studies), stroke (5 studies),…