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Artificial intelligence could be leveraged to reduce the administrative burden associated with laborious, site-specific documents to provide clinical trial teams more time to conduct high-priority tasks such as identifying, screening, and enrolling patients.

It’s no secret that the clinical research enterprise faces many struggles related to attracting and retaining qualified physicians to serve as principal investigators (PIs) for clinical trials. All too often, the first trial a PI completes is also their last one. However, when someone with a passion for research takes on the PI mantle as a true calling, it becomes part of their professional and personal identities. 

One of the most common and important types of quality management measures in clinical research is the Corrective and Preventive Action (CAPA) plan. Learning the CAPA process will provide insight into how corrective and preventive actions are handled, along with creating an effective game plan for your use of CAPAs. 

Diversity in clinical research has become a hot topic in recent years, with heightened attention leading to dramatic changes in the regulatory framework, including U.S. legislation broadening the scope of diversity consideration in clinical trials. In an article for the forthcoming August issue of ACRP’s Clinical Researcher journal, Faith Holmes, MD, Chief Medical Officer, and Kristen Snipes, CCRA, Executive Director, Project Delivery, both with Elligo Health Research®, examine how, despite this increased awareness and regulatory push, many long-standing challenges persist.

Within the clinical research enterprise, as can be seen elsewhere in business and regulatory landscapes, the terms “quality” and “compliance” often intersect, creating what some feel is a symbiotic relationship crucial for organizational success. However, despite their frequent association, these terms embody distinct philosophies and practices.