Vice President, Global Study Start-Up
Andrea Ochoa has over 19 years of clinical operations experience in a variety of roles, specializing in study start-up for the past 10 years. In her current role, she oversees Premier Research’s start-up function while providing expert advice and strategies to operationalize and navigate the complex global regulatory and start-up environment.
Victoria Watts, CIPT
Global Data Protection Officer
Victoria Watts has compliance and legal risk management experience in a variety of industries, most recently within clinical research. She has extensive experience in formulating, operationalizing, and implementing data protection compliance programs and is an expert in interpreting the General Data Protection Regulation (GDPR) as it relates to clinical research.
The direct-to-patient clinical trial model has gained popularity in recent years, and social distancing concerns have only accelerated this trend. In this model, on-site clinical assessments are limited, and study materials are delivered to patients at home to minimize site visits and provide added convenience for participants. While this arrangement offers many advantages, there are some things to consider before jumping in.
Andrea Ochoa, Premier Research’s Vice President of Global Study Start-Up, and Victoria Watts, our Global Data Protection Officer, join Dr. June Chen this episode to discuss these topics, including:
- What to consider when using technology solutions to ensure data integrity
- How to protect patient privacy
- What recent events suggest about the “new normal” for clinical research
COVID-19 & Clinical Trials: Direct-to-Patient Model Keeps Research Moving and Patients Safe
Real-World Data and Real-World Evidence: What Is Their Value as a Synthetic Control Arm?