Liz Wool, RN, BSN, CCRA, CMT, President, Wool Consulting Group Inc.

Trial Practitioners Grapple with Stringent ICH GCP E6(R2) Demands

Updated expectations in the International Council for Harmonization’s (ICH’s) guideline for Good Clinical Practice (GCP) E6(R2) are changing the way institutions and investigators calibrate and implement appropriate and adequate approaches for qualifying external labs and other testing facilities, and for ensuring oversight of many of the trial-related tasks delegated to those outside organizations. Industry has […]

David Burrow, Director, Office of Scientific Investigations, Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

FDA Official Encourages Robust Industry Dialogue

There’s nothing like getting backup from the U.S. Food and Drug Administration (FDA) during a debate with your boss. Just ask popular ACRP conference speaker David Burrow, PharmD, JD, director of the FDA’s Office of Scientific Investigations within the Office of Compliance for the Center for Drug Evaluation and Research. “Some of the most rewarding […]

Dartmouth-Hitchcock Health

Dartmouth-Hitchcock Health Joins ACRP’s Clinical Research ‘Workforce Innovation Steering Committee’

The Association of Clinical Research Professionals (ACRP) welcomes Dartmouth-Hitchcock 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 partnership […]

John Neal, CEO of PCRS Network

Looming Changes Could Catch Clinical Trial Professionals Off Guard

Virtual clinical trials won’t eliminate the need for clinical trial professionals anytime soon, and the technology’s most dazzling predictions are likely years away from having a big impact on sites and the clinical trial workforce. However, that’s not an excuse to sit back and passively wait to see what’s coming next, says John P. Neal, […]

The Training Challenges in Billing and Research Compliance

Clinical Researcher—March 2019 (Volume 33, Issue 3) PEER REVIEWED Kelly M. Willenberg, DBA, RN, CCRP, CHRC, CHC Clinical trial billing is the process of ensuring that, from the coverage analysis to a claim reimbursement, you have revenue integrity. From the negotiation of a budget and contract against the coverage analysis to the revenue charge review […]