by SOCRA | Jul 19, 2021 | Clinical Research, Monitoring, Project Management, Protocols, quality management, Trial Management
Tracy Popp, MBAPreviously: Director, Research Financial Operations Norton Healthcare, Inc.Currently: Senior Director of Clinical Research, Tampa General Hospital Abstract: It is important for clinical research sites to operationalize the serious adverse event (SAE)...
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 5, 2021 | Clinical Research, Clinical Trials Day, SOCRA Member Highlights
May 20th marks Clinical Trials Day (CTD), an international commemoration of James Lind’s launch of the scurvy clinical trial on May 20, 1747, which would form the foundation for modern clinical research. Celebrated for the first time in 2005, CTD raises clinical...
by SOCRA | Apr 1, 2021 | Clinical Research, Good Clinical Practice (GCP), Study start-up
Michael Mapel, CCRPClinical Research LeadUCLA Pediatrics Office of Finance & Research Children’s Discovery & Innovation Institute1 Abstract: Activating a clinical research project at an academic medical center requires significant planning and effort from...
by SOCRA | Mar 10, 2021 | Clinical Research, Professional Development, Project Management, Training
Takisha Adair, Clinical Operations Manager, Covance Abstract: Retaining staff is challenging for clinical research organizations. Motivating employees and engagement can help reduce staff turnover. Organizational leaders who desire to retain a talented workforce...
