09.12.26 -- Beyond Reviewing Data: RBQM And EDC Integration

Rebecca Jackson offers a candid reality check on EHR-to-EDC integration, AI, and clinical trial technology, arguing that innovation must solve real operational problems — not create new ones.

After COVID forced sponsors to move faster than ever, many are now confronting a harder challenge: ownership. Marci Thear explains why RBQM and centralized monitoring only work when sponsors move beyond reviewing outputs and start acting on the signals.

Leida Bowen explains how patient councils and early community input can inform protocol design, reduce burden, and ensure trials reflect patient needs before study execution begins.

Protocol design directly affects recruitment, data quality, and startup speed. Clear workflows, streamlined criteria, and early alignment reduce delays, amendments, and improve reliable study execution.

By collapsing the gaps between manufacturing and clinical trials and integrating these functions into a unified system, teams can adjust formulations in real-time and accelerate timelines.

Gene therapy immunogenicity requires platforms, judgment, and regulatory fluency beyond ADA norms. Relying on biologics criteria creates gaps; CGT expertise ensures reliable, interpretable results.