The Modern CRA: Operationalizing Data-Driven Site Success

As clinical trials become more complex, leading sponsors are shifting the focus of their clinical research associates (CRAs) from traditional compliance monitoring to proactive, data-enabled site support and oversight. Skill development, structural changes, and the use of advanced analytics are modernizing the CRA role—and the way we monitor clinical trial sites.

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 […]

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