News By: Emily Norris

Clinical research professionals operate in an environment of constant change. New regulations, evolving guidance, increasing enforcement activity, and emerging technologies continue to shape how research organizations manage compliance and protect research participants. Keeping up requires more than reviewing regulatory updates. It means learning from experienced compliance leaders, connecting with peers facing similar challenges, and gaining practical strategies that can be applied immediately. 

Many organizations face financial strain as they are asked to support investigator-initiated clinical trials with little or no budget or to absorb hidden costs arising in sponsor studies. Practical strategies are needed to identify and manage this risk at sites, using tools to evaluate feasibility, recover costs and make decisions at the portfolio level. This will enable continued innovation, while building mission-driven research efforts that are likely to gain funding in future.

I first became a CRC in 2004, and I love my job. But there is a part of being a CRC that no one talks about enough: the mental weight of always having so much in motion.

For clinical research sites, manual data entry remains a substantial burden that drains resources and increases study timelines. This impact is worsening as clinical trials become increasingly complex, with more endpoints, procedures, inclusion/exclusion criteria, and data sources. 

New approaches are required to comply with the ICH E6(R3) guideline for Good Clinical Practice (GCP), intended to drive a culture of quality. These include new ways of working, use of proportionate risk-based methods, and a culture that favors quality and rewards critical thinking.