06.04.26 -- Why Clinical Execution — Not Tech — Is Trials' Biggest Risk

Continuous, risk-based data cleaning improves trial integrity, compliance, and outcomes. Learn how leading teams are shifting from reactive to real-time approaches.

ISPOR CEO Rob Abbott explains HTA-integrated trials, digital twin evidence gaps, and SaMD update challenges, and the one change needed to future-proof clinical tech.

Part 2 examines AI model migration risks, including data residency, compliance exposure, and maintaining regulatory-grade records during system transitions.

The FDA’s real-time review pilot highlights a move toward continuous, regulator-ready data, reshaping how sponsors prepare submissions and manage trials.

Agentic AI reduces variability, accelerates workflows, and supports compliance, helping clinical teams scale efficiently as trial complexity increases.

Centralized data access, AI automation, and traceable workflows enable faster reviews, better decisions, and reduced compliance risk in clinical trials.

New U.S. pricing policies, including IRA reforms, may reshape innovation incentives. Explore unintended consequences for R&D, access, and global competitiveness.

Insights from Deepak Ananthan on structured data, AI, and interoperability, and how organizations can act now to enable more patient-centric trials.

Selecting an IRT partner for complex trials requires the right expertise and flexibility. These five questions help reduce risk and ensure execution readiness.