Event Calendar

Data Management / EDC

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2018 Agenda

2019 Agenda Coming Soon! 

Friday, September 28, 3:25 to 4:10                                          

Trial Master File: Transition from Repository to Study Management Tool 

Following the release of ICH GCP E6 and the draft EMA guidance on the Trial Management File (TMF) the industry is transitioning from a repository which should be complete at the end of a study to a study management tool for communication, management and oversight.  Ms. Malia will discuss how this change came about and considerations for companies as they move forward. 113

Presenter: Joanne Malia, BS, MS, MS, Associate Director, Clinical Documentation Management, Regeneron Pharmaceuticals 

Track: Data Management / EDC

Friday, September 28, 4:15 to 5:00                                           

Electronic Clinical Trial Management Systems: The Basics, Needs, and Outputs 

Mr. Wieczerzak will discuss the basic structure, need, and importance of having an electronic clinical trial management system at the sponsor/CRO level. The various benefits of using an integrated CTMS system such as linking other systems, running reports and other various outputs will be presented as well as the requirements and regulations needed when using an electronic CTMS. 115

Presenter: Michael Wieczerzak, BS, MS, CCRP, Associate Director of Clinical Trial Management  

Track: Data Management / EDC