Insights

Clinical trials have become more complex, due to myriad factors including rising protocol demands, the adoption of decentralized models, and the integration of artificial intelligence. While these innovations promise greater personalization and operational efficiency, they also introduce new layers of logistical and regulatory complexity. Sponsors and CROs should collaborate to design site-centric processes that reduce operational burden, streamline communication, and allow research teams to focus more on patient care and data quality.

Although researchers are required to consider sex as a biological variable, the field of sex-based biology and medicine remains underdeveloped and often mischaracterized as peripheral. This article investigates gender disparities in clinical trials and pharmacology, focusing on adverse drug reactions and highlighting critical areas where differences in drug tolerability between genders are most significant, particularly in the management of insomnia.

Institutional review boards (IRBs) are federally required committees that evaluate research involving human subjects to safeguard participants’ rights, safety, and well-being. Their oversight guarantees adherence to federal laws, institutional policies, and ethical standards. Before starting any study with human participants, researchers must submit their research plans to the IRB for review and approval.

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.

Global trials can unlock real advantages for sponsors, including access to diverse patients, faster enrollment, and more representative data across geographies. However, global expansion isn’t always the right move. For every sponsor that benefits, there’s one that overspends, underdelivers, or enters markets they were never built to support. In a high-risk industry that punishes missteps and rewards efficiency, the question any sponsor should ask isn’t how to go global. It’s whether they should at all.