by SOCRA | Mar 30, 2023 | Clinical Research, FDA
In Interview with Andrace De Yampert, MS This Women’s History Month, we’d like to express our gratitude to those in the clinical research community who dedicate their careers to advancing inclusivity and equality in our field. Whether through small acts of empowerment...
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 | 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...
