Track 3: Data and Technology
Innovative technologies are improving efficiency in the collection of data from clinical trials through the product development lifecycle to patients. This track focuses on recent developments in clinical data curation, data development, and harnessing data across the product lifecycle which includes the structure, organization, validation, storage, extraction, and delivery of diverse types of patient data to facilitate review, analysis, and reporting in regulatory submissions. Specifically, the track will have the following as focal points:
- Structured data sources
- Data quality
- Cloud-based regulatory submissions
- Digital health outcomes
- Data standards
- Real-world data (RWD) and real-world evidence (RWE)
- Global health authority collaboration
- Data integration, sharing, and protection
- AI and emerging technologies
- Emerging policies and regulations
DIA recommends this track and associated sessions to professionals involved in: informatics (bio and medical), data standards and quality control (and regulatory standards implementation specialists), data quality, clinical data management, clinical trial design, clinical operations, electronic health records, structured data submissions, and global submissions, health economics outcomes research, biostatistics, medical writing, real-world evidence, pharmacoepidemiology, post-market studies, and regulatory affairs and operations.
Included Topic Areas
The broad range of data that is generated during biopharmaceutical development, approval, and post-market will be covered in this track including: clinical (including data from electronic health records, wearables, and other mobile apps), real-world data from large data sets, including registries and national datasets, claims data, and payor/HTA expectations for real world data, and new technologies to support HTA and regulatory submissions.
Priority Topics
- Pharmacoepidemiology and Real-world Evidence (RWE)
- Access and Equity
- AI and Emerging Technologies
- Data Access, Standards, Sharing and Exchange
- Driving Adoption through Policies and Regulations