06.14.25 -- Clinical Leader, The Best Of May

If E6 (R3) is ushering in the era of Quality by Design, clinical development consultant Angus Henderson says it's time we talk seriously about oversight by design.

Consultant Denise Bronner details pharma's strategic rollback of DEI initiatives, roles, and even departments and explains why well-meaning but misguided intentions enabled their demise.

GCP consultant Donatella Ballerini explores how AI is shaping eTMF management and what this means for the future of clinical research in part one of this series.

By analyzing patient data sets, AI enhances predictive analytics, supports real-time patient alerts, and strengthens continuous monitoring — improving the effectiveness of clinical trial oversight.

While compassionate use and expanded access programs provide lifesaving treatments outside clinical trials, the lack of structured protocols can lead to inconsistent data, compromising crucial evaluations.

Facing economic pressures, regulatory changes, and technological advancements, CROs must redefine their value propositions and discuss the need for reinvention in 2025 to accelerate into the future.