Early Data Strategy: Building Today's Trial For Tomorrow's Scalable Success

For a small biotech sponsor launching a Phase II rare disease trial, early data strategy was critical to navigating protocol complexity, niche endpoints, and multi-source data requirements—all without an internal data management (DM) team. Veristat was engaged at the protocol finalization stage to build a scalable, streamlined data collection approach tailored to tight timelines and limited EDC/ePRO experience.

Veristat’s DM experts led a strategic evaluation of three electronic data capture (EDC) systems, selecting a platform that balanced functionality, site usability, and future scalability. They developed SDTM-aligned case report forms (CRFs) that prioritized essential data, minimized redundancy, and supported regulatory readiness. A focused data collection strategy reduced site burden while ensuring capture of key endpoint-aligned elements. Explore how Veristat created a forward-looking roadmap for their integration, ensuring a future-ready data ecosystem without overcomplicating current operations. By embedding DM strategy early, the sponsor avoided common pitfalls and established a strong data foundation—delivering clean, submission-ready data while positioning the study for seamless expansion into future trial phases.