CRCs ‘Absolutely Critical’ to Success of Precision Clinical Trials

New technologies and concepts are all well and good. However, they won’t advance precision clinical trials alone. The key to success? Clinical researcher coordinators (CRCs). That’s the verdict of one of the winners of a recent clinical trial challenge affiliated with the Harvard Business School (HBS). “Without fantastic CRCs, we wouldn’t be as successful,” says […]

FDA Calls for Increased Clinical Trial Diversity

It’s time for the clinical trials industry to step up to the plate and do everything it can to champion diversity in clinical trial participants, says Jonca Bull, MD, Assistant Commissioner for Minority Health with the Office of Minority Health in the U.S. Food and Drug Administration (FDA). “Participants need to more closely mirror the […]

National Academies Report Calls for Withdrawal of Common Rule

Congress and the Obama Administration still have time for a critical “course correction” by withdrawing the Notice of Proposed Rulemaking for the “Common Rule,” according to the final portion of a report issued by the National Academies of Sciences, Engineering, and Medicine on June 29. The chair of the committee that wrote the report, Larry […]

Change is in the Air: Part VI

This is the sixth installment in the series on changes coming to the clinical research enterprise that John Neal, CEO of PCRS Network, LLC,  began in April 2016, with the prediction that “major changes are coming that will be disruptive, displacing many people currently working in the industry.” Prediction 6: There will be fewer studies […]

Navigating the Perils and Promise of Centralized Clinical Management

The leaders of institutions involved in the conduct of clinical research have the option of various models for managing their clinical research personnel. When considering a centralized or hybrid model for management of such professionals, experts advise that the organizational leaders must engage stakeholders early and often in the process, and build in flexibility to […]