May 19, 2021 — Biomarker data generated to support clinical development has multiple roles:
- Inclusion in end-of-study regulatory submissions. As such, data must conform to FDA data exchange standards and need SDTM programming for analysis and submission.
- Supporting on-study decisions. Data must be stored in an accessible, flexibly structured format to adapt to on-study needs. These diverse needs include data visualization, mock TLFs, materials for investor meetings, posters, and reporting for safety review, data monitoring, and dosing decisions.
- Enable deep exploration to generate translational insights. Biomarker data generated during clinical trials presents opportunities for sponsors to further characterize mechanism of action and prioritize additional target pathways for their pipelines.
