Earlier this month, the U.S. Food and Drug Administration (FDA) debarred a study coordinator for a drug clinical trial at an institution in the agency’s Northern District of Illinois, alleging the use of fictional patients and skewed reports, among other serious charges. While it represents an “extreme and rare example,” the FDA’s action should serve […]
With a tightening clinical trial marketplace and an increasingly stagnant per-patient value, study sites are under ever-greater pressure to find new ways to reach new subjects and satisfy some wary sponsors, says Christian Burns, a specialist in clinical site business development and patient recruitment with ClinEdge. The key is flexibility and recognizing new market segments. […]
Comments submitted regarding Public Notification of Emerging Postmarket Medical Device Signals ("Emerging Signals"). (Docket number: FDA-2015-D-4803). Click here to read the comments and impact on ACRP Members.
Clinical research site staff report communication, protocols, and monitors as the three most critical aspects of successful relationships with their CRO and sponsor research partners, according to new data from a collaborative research study by ACRP and CRO Analytics. In a survey of nearly 300 clinical research sites, the majority of respondents listed these three […]
The Association of Clinical Research Professionals (ACRP) continues calling for a groundbreaking shift in the clinical research industry: elimination of the commonly accepted and practiced two-year experience requirement for entry-level Monitors/Clinical Research Associates (CRAs) in favor of competence-based employment practices. An article in today’s CWWeekly (“The ongoing CRA shortage: Competency versus experience”) notes that “at […]