Future Clinical Trial Landscape Demands New CRA Skills

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 […]

‘Digital Twin’ Advances Poised to Expand Clinical Trial Reach

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 […]

UC Davis Health Joins ACRP’s Clinical Research ‘Workforce Innovation Steering Committee’

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 […]

Are You Ready to Handle an FDA Form 483?

“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 […]

FDA Headquarters

FDA Officials Shower Investigators with Praise—And a Few Warnings

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 […]