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A “clear inconsistency” in site monitoring process outcomes during clinical trials is placing an “unsustainable” strain on the demand for and management of clinical research associates (CRAs) today—and it’s only going to get worse unless the industry reconsiders how it handles technology and workforce training, according to a new white paper from IQVIA. “There […]
If the term “digital twin” conjures up scary images of Frankenstein-like human experimentation or “Westworld”-style human-replicating androids run amok, don’t worry. It’s actually a scientifically sound concept on the verge of boosting clinical trial performance and reach, says advocate Charles K. Fisher, PhD, founder and CEO of Unlearn.AI. “A digital twin that is an exact […]
The Association of Clinical Research Professionals (ACRP) welcomes UC Davis Health as the latest member of the ‘Workforce Innovation Steering Committee’ (WISC). The WISC is a collaborative partnership of private and public stakeholders working to improve clinical trial quality and respond to changes impacting the workforce by providing oversight for needed standardization activities. The […]
“The best way to survive an FDA inspection is to always be prepared for one,” advises Michelle Anantha, MSPAS, PA-C, RAC (US), with the U.S. Food and Drug Administration’s (FDA’s) Center for Drug Evaluation and Research (CDER), Office of Compliance, Office of Scientific Investigations, Division of Enforcement and Postmarketing Safety, Compliance Enforcement Branch. If that […]
Leading U.S. Food and Drug Administration (FDA) officials hailed clinical study investigators as some of the unsung heroes of the clinical trial ecosystem during an agency training course last week in College Park, Md. However, regulators also reminded anyone contemplating leading studies to understand just how difficult the principal investigator (PI) role can be. “It’s […]
