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Type: 03: Data-Tech in Clinical Trials [clear filter]
Monday, June 20
 

1:15pm CDT

#111: The Role of Sensors in Clinical Research: Integrating Sensor Generated Data into Data Platforms to Power Clinical Research and Patient Care Room 179

1:30pm CDT

#114: Data Integrity Across the Product Lifecycle Room 183 B

4:00pm CDT

#134: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 178
 
Tuesday, June 21
 

9:00am CDT

#203: The Site Landscape: Data and Discussion of the State of the Clinical Research Site Room 178 #205: Optimizing Evidence Supporting Fit-for-Purpose Digital Clinical Measures Across the Drug Development Life Cycle Room 180

9:15am CDT

#209: New EU Clinical Trial Regulation: Experience So Far Room 184

11:00am CDT

#220: Collection of Quality Endpoint Data in a Decentralized Trial in Complex Indications: The Practical and Logistical Challenges Room 180 #223: Meeting Regulatory Expectations: What Needs to be Considered When Using Digital Technologies to Generate Clinical Evidence? Room 175

12:30pm CDT

#236 RT: Round Table Discussion: FDA Update on the Upcoming PDUFA VII Data and Technology Commitment Room 375 A Zone 1

1:45pm CDT

#243: Technology-Enabled Clinical Trials Using Electronic Health Record (EHR)-Derived Real-World Data: Opportunities and Limitations Room 176

2:00pm CDT

#248: Healthcare Datasets as Assets: Secure and Compliant Valuation and Transaction Methods Room 186 #249: Regulatory-Grade Real-World Evidence: Distilling to Practice Room 183 A #251: Data Science, Text Analytics, and Machine Learning to Derive Insights from Clinical Quality, Compliance, and Real-World Data Room 183 B

4:15pm CDT

#268: Life Science Research Innovation Powered by Real-World Data Room 183 A #270: Recommendations for Conducting Bring Your Own “Device” (BYOD) Clinical Studies Room 180 #271: Building the First Cloud-Based Submission Review Collaboration Platform Room 184
 
Wednesday, June 22
 

9:00am CDT

#304: Transformation of the Data Manager to the Data Scientist Room 470 B

11:00am CDT

#321: FHIR in Clinical Research Room 180 #320: De-Risking Decentralized: Understanding the Dimensions of Risk and Maximizing Data Quality in Decentralized Trials Room 176

1:45pm CDT

#342: Democratizing Data for Cancer Research and Real-World Evidence Generation Room 176 #343: Redefining the Value Proposition for Innovation: Connecting Data, Technology, and Quality to Improve Outcomes Room 179

2:00pm CDT

#347: Enabling Digital Transformation in Health Care and Clinical Trials Room 184 #349: The Power and Uncertainty of Data: How it Can be Used to Drive Efficiency While Recognizing its Limitations Room 186

3:15pm CDT

#360 CH: Considerations for Establishing Meaningful Change for Digital Endpoints Derived From DHT Drug Development Tools Room 470 A

4:15pm CDT

#368: Sneak Peak: First Share from Initiatives of a Global Collaboration to Address Barriers to Decentralized Trial Scale and Adoption Room 183 A #370: Where Are we Really on Data Interoperability? Room 185 AB #369: Approaches to Addressing Diversity and Inclusion in Clinical Research Room 185 CD
 
Thursday, June 23
 

10:00am CDT

#405: How the Heck do I Get this Digital Endpoint to Work in my Clinical Trial? Nuts and Bolts for Trials Teams Room 176 #406: The PCORnet Response to COVID-19: The Importance of Partnerships, Data, and Digital Innovations to Provide Fast Answers Room 178 #407: Methodologies Used to Aggregate Real-World Data and Clinical Trial Data Room 179
 
Monday, June 26
 

10:45am CDT

Inspired by Big-Tech and Humbled by Complexity of Clinical Research: Clinical Trial Digital Transformation TBD

1:30pm CDT

Building Trust: Data Privacy in Decentralized Clinical Trials TBD Innovative Digital Health Technologies: Strategies for Successful Integrations, Quality, and Compliance TBD

4:15pm CDT

Digital Endpoint Qualifications in Clinical Trials: Collaborations and Applications TBD The True Decentralization of Clinical Trials: Benefits and Drawbacks of Blockchain Technology TBD
 
Tuesday, June 27
 

8:30am CDT

ICH M11 Clinical Electronic Structured Harmonized Protocol (CeSHarP): Enabling Consistency and Information Exchange TBD The Case for Generating Synthetic Data as Real-World Data: Regulatory and Planning Perspectives  TBD

10:30am CDT

The Future of Regulatory Submissions: Opportunities and Challenges TBD

1:15pm CDT

Global Regulatory Perspectives About Real-World Data: DARWIN EU®, FDA, and Other Current Initiatives TBD

4:00pm CDT

IDMP and Data Harmonization Methods: How Your Company will be Impacted TBD SMART-on-FHIR: Integrating Electronic Health Records as Real-World Data TBD
 
Wednesday, June 28
 

8:30am CDT

Real-World Data Quality: Components and Considerations of Data Sources Used for Regulatory Decision-Making TBD The Rapidly Changing Landscape of Data Collection and its Implications for Clinical Data Management TBD

10:30am CDT

Leveraging Data Scientists and Data Managers with Evolving Protocol Designs   TBD Operationalizing Real-World Data: Methods, Acceptance, and Future Hopes  TBD

1:15pm CDT

Managing BYOD and Wearables in Clinical Trials: Sustainable Data Collection TBD
 
Thursday, June 29
 

8:30am CDT

Effective Use of Intelligent Automation in Clinical and Regulatory TBD

9:45am CDT

Process Automation and Artificial Intelligence in the Field: Practical Applications TBD
 
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Exh Hall Community Area
Exhibit Hall
Exhibit Hall Booth #1719
Exhibit Hall Theater #1
Exhibit Hall Theater #2
Exhibit Hall Theater #3
Level 3 F2 Entrance
Meeting Rm Lobby Level 1
Meeting Room Lobby
Room 175
Room 176
Room 178
Room 179
Room 180
Room 183 A
Room 183 B
Room 183 C
Room 184
Room 185 AB
Room 185 CD
Room 186
Room 187
Room 375 A Zone 1
Room 375 A Zone 2
Room 470 A
Room 470 B
Room 471 A
Room Skyline 375 CDE
Skyline Ballroom Foyer
TBD
Virtual
  • 00: Plenary
  • 01 - Clinical Safety and Pharmacovigilance
  • 01: ClinSafety-PV
  • 02: ClinTrials -ClinOps
  • 03: Data-Tech in Clinical Trials
  • 04: MedAffairs-SciComm
  • 05: Patient Engagement
  • 06: PreClinical Dev-EarlyPhaseCR
  • 06 - Translational Sciences and Precision Medicine
  • 06: TranslationalScience-PrecisionMedicine
  • 07: ProjectManagement-StrategicPlanning
  • 08: RD Quality-Compliance
  • 09: Regulatory
  • 10: RegCMC-Product Quality
  • 11: Statistics
  • 12: Value-Access
  • 13: ProfDevelopment
  • 14: DIAmond
  • 15: Content Hubs
  • 16: Community Rounds
  • 17: Networking Opportunities
  • 18: Posters
  • 19: InnovationTheaters
  • 20: Short Courses
  • Level
  • Advanced
  • Basic
  • Intermediate
  • Featured Topics
  • AI and Machine Learning
  • COVID-19
  • Data Science
  • Decentralized Trials
  • Digital
  • Diversity Equity and Inclusion
  • Innovative Trial Design
  • Patient Perspective
  • Personalized Health Care
  • Regulator Perspective
  • Remote Work
  • RWD-RWE
  • Special Populations
  • Student Programming