Two Full Days of Industry Best Practices, Trends and More

Agenda Subject to Change

TUESDAY, DECEMBER 4 SESSION SPEAKER
8:00 - 9:00 Breakfast
9:00 - 9:15 Opening Remarks Bill Byrom, CRF Bracket
9:15 - 9:45 Keynote T.J. Sharpe, Patient Advocate
9:45 - 10:15 Industry Perspective on FDA’s Patient-Focused Drug Development Guidance Series Nikunj Patel, AstraZeneca
10:15 - 10:45 Panel: What Role Does Electronic Approaches Have in the Research of Patient-Focused Drug Development? Ashley Slagle, Aspen Consulting
Nikunj Patel, AstraZeneca
T.J. Sharpe, Patient Advocate
10:45 - 11:15 Networking Break
11:15 - 11:45 "BYOD or not to BYOD”, Recent Research Results and Their Implications for eCOA Willie Muehlhausen, Muehlhausen Ltd
11:45 - 12:15 Migration Evidence to Support Use: Case Study Workshop Bill Byrom, CRF Bracket
Serge Bodart, CRF Bracket
12:15 - 1:15 Lunch
1:15 - 2:15 Panel: Leveraging Patient-Reported Outcomes in Oncology Ashley Slagle, Aspen Consulting
Ari Gnanasakthy, RTI Health Solutions
2:15 - 2:45 Approving Library Versions of Instruments That Can be Applied, Under License, Without Further Author Approvals Michelle White, Optum
2:45 - 3:15 Networking Break
3:15 - 3:45 Optimizing the use of Mobile Technologies in Clinical Trials Jen Goldsack, monARC Bionetworks
3:45 - 4:15 Panel: Wearables & Sensors Jen Goldsack, monARC Bionetworks
Mark Wade, Transperfect
Bill Byrom, CRF Bracket
4:15 - 4:45 Best Practices for Licensing and Translation Activities During eCOA Study Startup Ashley Deane, ICON
4:45 - 5:00 Closing Remarks Bill Byrom, CRF Bracket
5:30 - 7:30 Networking Reception Revolution House

 

 

Wednesday, December 5 Topic Speaker
8:00 - 9:00 Breakfast
9:00 - 9:15 Opening Remarks Bill Byrom, CRF Bracket
9:15 - 9:45 Enhancing Data Quality and Rater Reliability with eClinROs Dan DeBonis, CRF Bracket
9:45 - 10:15 Case Study: eCOA Version of the OAS-M Emil Coccaro, University of Chicago Medical Center
10:15 - 10:45 Evaluation of Measurement Properties of Selected Physical Performance Outcome Assessments: Case Study and Lessons Learned Rachel Ballinger, ICON
10:45 - 11:15 Networking Break
11:15 - 11:45 Case Study: Equivalency Testing of a Clinician Administered Observer-Reported Outcome (ObsRO) For Use in Autism Following Migration to eCOA: Case Study Rebecca Grimes, Adelphi Values
11:45 -12:15 Best Practices for Usability Testing to Improve the eCOA Patient Experience, Particularly in BYOD Studies Alisa Heinzman, RWS Life Sciences
12:15 - 1:30 Lunch
1:30 -1:50 Keynote: What Does Harry Potter Have in Common with eCOA Joseph Kim, Eli Lilly
1:50 - 2:20 The Power of Integrated Patient Engagement Jeff Lee, CRF Bracket
2:20 - 2:50 Panel: Future Trends Joe Kim, Eli Lilly
Willie Muehlhausen, Muehlhausen Ltd.
Jeff Lee, CRF Bracket
David Stein, D. Bartley Consulting
2:50 - 3:20 Networking Break
3:20 - 4:00 Use of eCOA Metadata to Detect Fraud, Develop Risk Indices and More: Presentation and Audience Discussion Jill Platko, CRF Bracket
4:00 - 4:15 Closing Remarks Bill Byrom, CRF Bracket