Beyond Compliance: Vivalink's Cecilia Xi, PhD, on Data Provenance and Sustainable Device Strategy in Clinical Trials

In this episode of Beyond Compliance, host Otis Johnson, PhD, MPA, founder and principal consultant at Vantix Operations, talks with Cecilia Xi, PhD, VP of clinical and scientific affairs at Vivalink, about what it takes for clinical trial data to remain traceable, reproducible, and defensible years after collection.

Xi explains that strong data provenance requires integrity across both time and space, tracking not just when data was collected but how it moved from raw device output to final dataset, with clear logging of any missing data or imputations. She contrasts this with traditional site-based measurements, noting that connected devices generate far greater data volume and noise, requiring automated auditing methods rather than manual review. Xi also stresses that sponsors cannot outsource accountability for their data, even when platforms and vendors do the collecting, making early data repository transfer essential to avoid loss if a vendor relationship ends.

The conversation turns to sustainability, where Xi describes how reusable, clinical-grade devices can sharply reduce operational waste compared to disposables, provided sponsors manage device service life, calibration, and consistent training across patients and sites. She closes by outlining what sponsors should evaluate in technology partners, from regulatory clearance and financial stability to encryption, non-proprietary data formats, and API access, and urges a shift from reactive compliance to treating trial data as a proactive, quality-driven scientific asset.

Key takeaways

• Strong data provenance requires integrity both temporally and spatially, meaning traceable timestamps, sources, and documented transformations from raw device data through to the final dataset.
• Continuous data from connected devices generates far greater volume and noise than traditional site-based measurements, making manual auditing impossible and requiring automated verification methods.
• Sponsors should secure their own data repository soon after study completion, since losing platform ownership or control can mean losing access to historical data if a vendor relationship ends.
• Reusable, clinical-grade devices can significantly cut operational waste compared to disposables, but require managing service-life expiration, recalibration, and consistent training across patients and sites to maintain data quality.