Upcoming Events
Setting Up for Success: How MedTech Companies are Streamlining Clinical Trial Operations with Risk-Based Strategies
Wednesday, June 22, 2022 (11:00 AM - 12:00 PM) (EDT)
Description
Global regulatory agencies have recently highlighted the importance for Clinical Operations to identify, manage, and report risks associated with critical quality factors to answer key questions and support sound decision-making, all while protecting trial participants. In support of the evolving regulatory landscape, MedTech organizations are increasingly taking a risk-based, fit-for-purpose approach in the use of technology to conduct their trials.
Join this session to learn about the holistic technology approach that enables organizations to streamline their clinical trial monitoring and oversight strategies.
SPEAKERS
 | Brian Barnes Brian has over 15 years in the clinical development space and specifically supported RBQM for the past 10 years specializing in operational solutions for small to large pharma, biopharma, and biotech companies. Brian is a co-liaison within the Associate of Clinical Research Organizations (ACRO) RBQM Working Group and presented and published on the topic of RBQM within a number of industry meetings, conferences, and journals. Brian received his Bachelor of Science in Kinesiology from San Diego State University and Masters of Art in Human Physiology from University of Texas at Austin. |
 | Jana Hydukovich A leader with expertise in quality and regulatory matters concerning clinical trials. Jana joined Medidata’s Global Compliance & Strategy organization and brings to the team over 15 years experience in overseeing Quality Management Systems and Regulatory Affairs programs for clinical trial Software as a Service (SaaS) providers and medical device companies. Currently, Jana is leading the Quality System efforts around Medidata’s Software as a Medical Device initiatives. |