by SOCRA | Jun 14, 2021 | Clinical Research, clinical research regulations, Compliance, FDA
Mike M. Rashti President, BIMO Auditor and Trainer, LLC Abstract: This article provides an overview of the U.S. Food and Drug Administration’s (FDA’s) foreign inspection program and the Bioresearch Monitoring Program as it is applied to inspections in Canada. How to...
by SOCRA | May 13, 2020 | Clinical Research, clinical research regulations, COVID-19
Defining a “New Normal” in Clinical Research to Support the World’s 336,747 Research Studies By: Jennifer Goldfarb – MSN, RN, CCRP As of April 21, 2020, according to clinicaltrials.gov, there were 336,747 research studies registered by organizations in all 50...
by SOCRA | Apr 23, 2020 | Compliance, Finance and Budgeting, Technology, Training
By: Kelly Willenberg, MBA, BSN, CCRP, CHRC, CHC Kelly Willenberg & Associates Abstract: Mobile technology, social media, and health information technology can help clinical research sites handle billing compliance. This article describes digital tools that...
by SOCRA | Mar 29, 2020 | Clinical Research, clinical research regulations, FDA, FDA Drug Approval
U.S. Food and Drug Administration, Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA). As our society becomes more global, it has become increasingly clear that the U.S. Food and Drug Administration needs to take a more...
by SOCRA | Dec 20, 2019 | clinical research regulations
James F. Bush, Esq. [1] Abstract In 2018, the European Union’s General Data Protection Regulation (“GDPR”) came into full force and effect. With the growth of international multi-center clinical research studies, U.S.-based research organizations and investigators...
