by SOCRA | Dec 11, 2024 | quality management
Viswakanth Makutam, Pharm D, Msc, ACRP-CP The Role of Quality Assurance in Clinical Trials Clinical Research Quality Assurance is a vital part of today’s successful clinical research, ensuring that research studies are run in compliance with regulatory requirements,...
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 | 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...
