Course Description - Course runs 9:00 to 5:00 both days (Breakfast & Lunch Included)

This course explores the international challenges of trial records management: people, culture, and systems. With so many trials occurring in Brazil, Russia, India, China, South Korea and Turkey, as well as the US, Canada and Europe, the confluence of cultures presents unique challenges. This course offers suggestions for building a workable, sustainable system for clinical documents and data with practical templates, processes and solutions to common problems. This course also reviews the range of documentation that sponsors and sites need to control and generate for a successful outcome. It also addresses what to do with records once a trial is complete.

Who Should Attend

Conducting clinical trials and accruing accurate and viable data is the most expensive component of the drug development paradigm. Clinical teams are held accountable to ensure the most efficient and effective delivery of high quality data from each and every trial that they complete. Even in this day of electronic data transfer for many aspects of a trial, how those data are collected, reviewed, archived and retrieved has become a logistical nightmare for many clinical teams. This course aims to support all those team members who touch some aspect of clinical documentation in understanding the importance of the data/paper flow based on the specifics of their clinical protocol and existing systems. Typical attendees include:

• Project Managers, Directors and Leaders
• CRO Staff Members
• Site and Sponsor Staff Members
• Clinical Investigators and Study Coordinators
• Clinical Operations Directors and Senior CRAs
• Clinical Trial Managers, Monitors and Associates
• Medical Affairs and Clinical Operations Professionals
• Quality Assurance Personnel
• Central Records Staff
• Document Management Staff
• Regulatory Managers

Kay Monroe

Specialties: Quality, Management

Kay Monroe is Acting Executive Director of Zagaya. This non-profit – specializing in Malaria – works to bring innovative technologies to the problems of global health in the developing world.

Ms. Monroe has spent over 25 years with biotechnology and pharmaceutical companies around the world; working on global project teams from Research through Phase IV and introducing Project Management Offices into several companies. She has extensive experience in product lifecycles and the creation of submission documents. In addition, she has sourced both items and processes for pharmaceuticals, biologics and devices.

Ms. Monroe has held positions as Vice President of Operations, Project Management and Quality Assurance in companies such as Lundbeck, Synarc and Genentech. She has extensive experience in the start-up environment with such companies as Cerus, Dynavax and Amyris.

Ms. Monroe received her Bachelors of Science in Animal Science from UC Davis and her MBA from Golden Gate University.