by SOCRA | Oct 24, 2022 | Clinical Research, Training
Anatoly Gorkun Senior Manager, Global Clinical Management, PPD Hugh Devine Senior Director, Global Clinical Management, PPD Abstract: Line management is generic, utilizing the same approaches throughout all industries; line management brings together company needs and...
by SOCRA | Oct 18, 2021 | Cancer Research, Clinical Research
Sara Balch, BS, Project Manager, Count Me In and the Broad Institute of MIT and Harvard Abstract: Count Me In is a research initiative whose aim is to engage patients living with all major cancer types, as well as those with rare cancers. Along with this goal, Count...
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 | Jan 4, 2021 | Trial Management
Michael Wieczerzak Associate Director, Clinical Quality Management, EMD Serono Abstract: Sponsors and contract research organizations should be using electronic clinical trial management systems to efficiently oversee their trials. This article describes the...