Program Overview

Career Development & Leadership

Data Review

eConsent

Niche

RBM

Tech

12:00 PM - 08:00 PM Registration
Evergreen Ballroom Foyer
08:00 AM - 12:00 PM  

 Leadership Forum*

Leading CDM from Today's Challenges to a Visionary Future
Sanjay Bhardwaj, Global Biometrics
Carol Schaffer, Pfizer


Upon invitation only
Schedule: 09:00 AM - 04:00 PM
12:00 PM - 01:00 PM
01:00 PM - 05:00 PM Pre-Conference Workshop*
Preparing Data for FDA Submission
Dave Izard, GlaxoSmithKline
05:00 PM - 06:00 PM
06:00 PM - 08:00 PM  Opening Reception
Grand Ballroom
*Pre-registration is mandatory and additional fee might apply for attending.
07:30 AM - 06:00 PM Registration
Evergreen Ballroom Foyer
07:30 AM - 08:30 AM Continental Breakfast
Evergreen Ballroom Foyer - Sponsored by Clinical Ink
08:30 AM - 09:15 AM SCDM Business Meeting
Evergreen Ballroom
09:15 AM - 10:30 AM Keynote Presentation
Steven E. Kern, Ph.D., Deputy Director, Quantitative Sciences, Global Health – Integrated Development, Bill and Melinda Gates Foundation

"Global Health Clinical Trials: Challenging Work in Challenging Situations"
10:30 AM - 11:15 AM Coffee Break - Exhibit Hall
Grand Ballroom
11:15 AM - 12:15 PM Session 1 - Everything I Know I Learned in Data Management [I]
Gregg Dearhammer, IQVIA
Session 2 - Harnessing New Technologies to Improve Data Review Efficiency [P]
Amy Wanamaker, Neon Therapeutics
Session 3 - eSource [PD]
Amy Nordo, Duke University
12:15 PM - 01:45 PM  Lunch - Product Showcases - Exhibit Hall
Grand Ballroom
01:45 PM - 03:15 PM  Session 4 - Data Management in the World of 'Direct to Patient' or 'Virtual Trials' [PD]
Arshad Mohammed, IQVIA
 Session 5 - Let’s DTQR: Define the Quality Relationship of Data Management within Clinical Trials [P]
Sara Doolittle, Premier Research
 Session 6 - eSource Implementation at Academic and Industry - Sponsor Sites [PD]
Michael Buckley, MSKCC; Rakesh Maniar, NVS
 Session 7 - Technology Ignite - Spark the Future [I]
Debra Jendrasek, Premier Research
03:15 PM - 04:00 PM  Coffee Break - Poster Presentations - Product Showcases - Exhibit Hall
Grand Ballroom
04:00 PM - 05:30 PM  Session 8 - Leveraging High Impact Information: Lessons and Best Practices in a Data Driven Culture [P]
Jennifer Price, Paidion Research
 Session 9 - Combining Standards and Technology to Accelerate Timelines and Efficiently Manage Clinical Trial Data [PD]
Dan Crawford, eClinical Solutions LLC
 Session 10 - Virtual Trials and the Data Manager [PD]
Stephen Cameron, PRA Health Sciences
 Session 11 - Therapeutic Area Knowledge in Clinical Data Management: Setting Expectations [RT]
Swati Tare, TCS
07:30 AM - 06:00 PM Registration
Evergreen Ballroom Foyer
07:45 AM - 09:00 AM Continental Breakfast
Evergreen Ballroom Foyer - Sponsored by Clinical Ink
08:00 AM - 09:00 AM Session 12 - Get Off My Cloud: How IT Infrastructure Affects Privacy and Performance in eClinical Systems [PD]
Scott Weidley, ClinCapture
Extra Session - GCDMP Revision Highlights [P]
Meredith Zozus, UAMS
Session 13 - "Don't You (Forget About Me)," The Breakfast Club...of Data Management! [RT]
Kate Solomon, PRA Health Sciences - PPD
09:00 AM - 10:30 AM Regulatory Panel
Demetris Zambas, Pfizer
10:30 AM - 11:15 AM Coffee Break - Poster Presentations - Product Showcases - Exhibit Hall
Grand Ballroom
11:15 AM - 12:15 PM Session 14 - More Than Checking Boxes: Integrating Electronic Informed Consent in a Compliant and Ethical Way [PD]
Cal Collins, OpenClinica LLC
Session 15 - Coalescing Research Data Services and Enabling Data Science at Academic Medical Centers [PD]
Emily Patridge, University of Washington
Session 16 - Does the Quality of Your Clinical Data Keep You Up at Night? [PD]
Julie Smiley, Oracle Health Sciences
Session 17 - Training the Past, Present and Next Generation of Clinical Data Managers [PD]
Kelly Ritch, MedNet Solutions Inc.
12:15 PM - 01:30 PM  Lunch - Product Showcases - Exhibit Hall
Grand Ballroom
01:30 PM - 03:00 PM Session 18 - Machine Learning, Artificial Intelligence in Data Management [P]
Appalla Venkataprabhakar, Novartis Healthcare
 Session 19 - Data Management in 2020, and Beyond [I]
Richard Young, Veeva Systems
Session 20 - Evolution or Revolution: How will Emerging Technology Innovations Change Data Management? [P]
Patrick Nadolny, Allergan
Krista Mullen,SDC
Session 21 - Utilizing GCDMP as a Training Tool for Clinical Data Managers [P]
Reza Rostami, DCRI

03:00 PM - 03:30 PM  Coffee Break - Exhibit Hall - Vendors Prize Draw
Grand Ballroom
03:30 PM - 05:00 PM Session 22 - Single Source of Truth, Integrations or IoT (Internet of Things): Exploring Ways to Improve Connectedness of Clinical Data [PD]
Joby John, Bioclinica
Session 23 - EHR Integration using SMART on FHIR [P]
Keith Howells, OmniComm Systems, Inc.
Session 24 - The Inspection Experience Through the Eyes of a Data Manager [P]
Maria Craze, Merck & Co.
Session 25 - Pop-Up Session
Cedar Ballroom
05:00 PM - 06:00 PM  Session 26 - Becoming a CCDM [P]
Meredith Zozus, UAMS
 Session 27 - From Data Management to Data Science: Raising the Bar for Scientific Abstracts and Presentations [P]
Richard Ittenbach, Cincinnati Children's Hospital
Session 28 - Pop-Up Session
Regency Ballroom A-D
07:00 PM - 09:30 PM Networking Reception*
Ascend Prime Steak & Sushi - Sponsored by Medrio, Oracle & Veeva Systems
*Pre-registration is mandatory and additional fee might apply for attending.
07:30 AM - 12:00 PM Registration
07:30 AM - 08:30 AM Continental Breakfast
Evergreen Ballroom Foyer - Sponsored by Clinical Ink
08:30 AM - 10:00 AM Closing Keynote Presentation

Kaye Fendt
"Clinical Data Integrity: The Central Role of the Data Manager"

Closing & Award Ceremony
10:00 AM - 10:30 AM Coffee Break - Evergreen Ballroom Foyer
10:30 AM - 12:00 PM Session 29 - Enabling Smart Central Monitoring Operations - Transitioning from Data Noise to Meaningful Signals in RBM [P]
Abby Abraham, Omnicomm Systems
Session 30 - Clinical Trials of the Future - Where are we headed? [RT]
Jonathan Andrus, Clinical Ink
Session 31 - Being Digital Clinical Data Manager, What it Means for the Industry! - A Visionary Approach to Revolutionize CDM Practices [PD]
Sangeet Kumar, Cognizant Technology Solutions
Session 32 - Time to Mutate: How Emerging Technologies will Shape the Future Role of Data Management [P]
Derek Lawrence, Rho, Inc.

LEGEND:

Oral Presentations [P] Panel Discussions [PD] Roundtable Discussions [RT] Ignite Presentations [I] Poster Presentations [PO]

This program is provisional and may be subject to change