Track 3: Data and Data Standards
The overarching themes of this track are Navigating Data and Standards in a Big Data World, and Explosion of Technology and the Change to the Role of the Data Professional. With 14 sessions specific to Data and Data Standards, this track will appeal to a broad audience as it addresses the data topic from the perspectives of:
- Sources, standards, quality, handling, and regulatory requirements
- Current and emerging applications of data
The full spectrum of data and its uses to support biopharmaceutical development, approval, and postmarketing use will be covered in this track including: clinical (eClinical from electronic health records, wearables, and other mobile apps), and real-world data from large data sets (including registries).
Sessions in Data and Data Standards
Sunday, June 24 | Short Courses
Monday, June 25
- Using Fast Healthcare Interoperability Resources (FHIR®) for Clinical Research
- Data Integrity Playbook: A Cross-Functional, Risk-Based, Analytics Driven Approach to Monitor Data Integrity
- Applying Artificial Intelligence, Machine Language, Natural Language Processing, and Predictive Models in Clinical Trials to Deliver Value to Multiple Stakeholders
Tuesday, June 26
- FDA Data Standards Update
- Common Data Model Harmonization for Evidence Generation
- Automation with Intelligence: From Standard-Based Solution to Metadata-Driven Automation
- Use of Electronic Health Records (EHRs) as eSource in Clinical Investigations
- Building up Efficiencies, Breaking Down Barriers: Using Mobile Technology for Data Capture in Clinical Trials
Triple-A RWE: Adequate Data, Appropriate Study Designs, and Actionable Evidence
Wednesday, June 27
- Building a Roadmap to the Implementation of the Risk-Based Monitoring Process: Facilitating the Perspectives of All Stakeholders
- Clinical Data: Let’s Get to the Source and Streamline it to the End
- Streamlining Vendor Reconciliation
- Do the Evolution: The Future Role of Clinical Data Management
- Evolving CDISC Standards and Technologies
Thursday, June 28
Who is This Track is Designed For?
Professionals involved in: Informatics (bio and medical), data standards and quality control (regulatory standards implementation), data quality, clinical data management, clinical trial design, clinical operations, eClinical (electronic health records), submissions and global submissions, health economics outcomes research, biostatistics, medical writing, real world evidence, epidemiology, postmarket studies, regulatory affairs and operations, and statistics.