Session 26 - Innovating in Real-Time - Keys to Running a Successful Decentralized Clinical Trial

  • #pioneer
Wednesday, September 16, 2020: 10:15 AM - 11:15 AM
/ CEU Credits:0.2

SESSION CHAIRS & SPEAKERS

Speaker
Alison Holland
Head of Decentralized and Remote trials
Medable
Speaker
Judy Moeller
Data Management Scientist
Janssen Pharmaceutical
Session Chair
Manny Vazquez
Senior Manager, Clinical Data Management
PRA Health Sciences
Speaker
Sina Adibi
CEO
Adaptive Clinical Systems

SESSION DESCRIPTION 

In recent years, the idea of running site-less, decentralized trials, aka virtual trials, has been discussed at length with many theories posited as to how such a trial would be executed, the systems that would be utilized, and how traditional team roles would fit into this evolving paradigm. In 2020, the rubber has met the road with numerous decentralized trials in process including an industry-first, indication-seeking trial. This session will bring together individuals from various functional areas involved in running these trials to discuss the roadblocks that have been encountered and the innovative solutions being employed, often in real-time, to implement these trials successfully. We will discuss how the theories of the past few years have translated into the real world, share experiences and lessons learned. A prime focus will be on the newest warrior to enter the arena of the project-level team, Information Technology. Suddenly, IT specialists without prior protocol experience are being thrust front-and-center to develop innovative, trial-specific data flow solutions and pushing data integration technology to the limit. As these trials become more commonplace, the goal of this session is to ensure our industry colleagues are informed of what is currently happening on the ground, discuss the solutions and come away better prepared to remove roadblocks and successfully execute a decentralized trial when it inevitably comes their way.

TOPIC


LEARNING OBJECTIVES

1. The current clinical landscape for decentralized trials.
2. Key considerations for technology and vendor selection.
3. Key startup strategies when implementing a decentralized trial.
4. Data flow considerations for IT and enterprise programming teams.

SESSION INFORMATION

CDM Certification Competencies::
Project Management,Electronic Data Collection,Data Management Plans

Target Audience:
Study Data Manager,DM Management,Information Technology Team