Reactions to Being “Powered By Purpose” on Clinical Trials Day 2025

As a follow-up to Clinical Trials Day 2025, held on May 20 with the theme of being “Powered By Purpose,” a collection of industry thought leaders shared their perspectives with ACRP on their clinical research powers, and on what they see as being the greatest current challenges and opportunities for the enterprise.

Detecting Fraud in Clinical Trials Using Statistical Data Monitoring

“Identifying … potential data manipulation and data integrity problems” are an International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) E6 (R3) requirement and foundational for ensuring research integrity. In this article, we examine statistical tests for continuous variables that have identified deliberate data manipulation in clinical trials and evaluate their […]

The Future of AI in pharma: Beyond the buzz to real-world impact

Artificial Intelligence (AI) continues to gain momentum in the pharmaceutical sector, but can it truly deliver the full-spectrum intelligence needed to improve clinical research outcomes, speed up insights, enhance patient safety, and ensure regulatory compliance?

Benchmarking Risks Across Therapeutic Areas

The monitoring of key risk indicators (KRIs) is an established form of risk control in the conduct of clinical trials. It is widely acknowledged that acceptable thresholds for KRIs vary by therapeutic area. However, the unavailability of benchmark data can limit the robustness of mitigations built into protocol and monitoring plans, in accordance with ICH […]

Where is RBQM Heading in The Future With AI?

Richard Young, Chief Strategy Officer at CluePoints, shares insights on AI and risk-based quality management (RBQM) in clinical trials. With experience at both CluePoints and Veeva, Young discusses AI’s role, transparency, and the future of risk management in clinical trials.