Technological advancements have broadened the reach of clinical studies to larger and more diverse populations. However, technology alone isn’t sufficient to guarantee successful trial outcomes. The human element, including how technology is utilized by sites, sponsors, and patients in accordance with regulatory guidelines, remains pivotal in ensuring compliance, minimizing risks, and upholding patient safety.
Our recent blog, published in DIA Global Forum, discusses how technology and human involvement can work together to conduct clinical trials in a compliant and safe manner. In this article, Bill Barrasso, Clinical ink Chief Compliance Officer, refers to the recent guidance from the FDA and EMA on using digital health technologies, software, and electronic data in clinical research. Bill also provides some recommendations and best practices for sites and sponsors to ensure effective planning and communication, as well as patient well-being and safety.
Read Human Interaction: Risk-Mitigation Recommendations When Using Technology in Clinical Trials and learn more about how effective planning and human engagement complement technology use in trials.