Barnett’s Clinical Research Training and Consulting

PAID MESSAGE - Barnett’s training and consulting services allow our clients to leverage our more than 30 years of expertise in training program design, gap analysis, needs assessment, curriculum development, and training program delivery. From program design to mock audits and findings-based training, competency mapping, and assessment, Barnett’s consulting offerings bring cost-effective solutions to our clients. […]

FDA Commissioner Scott Gottlieb, MD

FDA Offers Refined Gene Therapy Clinical Trial Expectations

A new series of guidances from the U.S. Food and Drug Administration (FDA) proffer a number of goals, including articulation of the agency’s expectations regarding how sponsors should provide sufficient chemistry, manufacturing, and control (CMC) information to address safety issues in the nascent world of human gene therapy. Commissioner Scott Gottlieb said the agency plans […]

Ken Skodacek, U.S. Food and Drug Administration

Don’t Let Technology Bury Your Clinical Trials with Frivolous Data

A dazzling new array of wearable and other mobile technologies can provide a more complete clinical trial picture, increase efficiency, and reduce the burden on patients, says Ken Skodacek, part of the U.S. Food and Drug Administration’s (FDA) Clinical Trials Program and Payer Communication Task Force at the Center for Devices and Radiological Health (CDRH). […]

Are You Ready for the Shifting Clinical Trial Landscape?

Five years ago, your contract research organization (CRO) was focused on asthma drugs. Today, the emphasis is on cardio-related treatments. Where will it (and perhaps many other CROs) be five years into the future? Finding the answer, or at least coming up with a good guess, is important for clinical trial professionals who want to […]