DIA
Drug Information Association Logo
« Back to Listing

Sustainable Solutions for Global Clinical Research Site Documentation

Track:
Processes and Technologies for Clinical Research

Day & Time:
June 18, 3:30PM - 5:00PM (Pacific Standard Time)

Session Number:
385

Room Number:
30CD

Level:
Advanced

Type:
Symposium

Title:
Sustainable Solutions for Global Clinical Research Site Documentation

Chair(s):
Betsy Fallen, RN
Principal
BAFallen Consulting, LLC, United States

Description:
In this age of cutting edge technology development, solutions have been developed to mitigate industry’s challenges. This symposium will include valuable information on the management of documentation between sponsor, their agents, and clinical sites. Discussion will include investigator portal, digital signatures, and case studies.


Learning Objective(s):
Define the changing landscape for process and technology options with insight from independent analysis and leading life science companies; Identify potential risks associated with managing documentation requirements on large global late phase programs; Recognize the special considerations for implementing and integrating digital signatures and investigator portals.

Presentation(s) & Speaker(s):
Digital Signatures 2.0: Current Usage and Landscape in Clinical Operations
Rodd Schlerf
FDA Markets Manager
CoSign by ARX, United States

Building an Investigator Portal from the Ground Up: The Decisions, The Pitfalls, and The Lessons Learned
Sukh Chugh, MBA
Director, R&D Informatics Services
Allergan, Inc., United States

Using Technology and Processes to Effectively Manage Regulatory Documentation Requirements for Late-Phase Clinical Research
Kate Trainor
Vice President and Global Head, Late Phase Project Management and Technology
PAREXEL International, United States