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 | 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...
by SOCRA | Nov 8, 2019 | Good Clinical Practice (GCP)
Amy Waltz, JD, CIPAssociate Director – Regulatory Affairs, Reliance, Outreach Indiana University Abstract: Understanding context is key to understanding the regulations and complying with regulatory requirements. This article explores the historical context and...
by SOCRA | Jan 25, 2019 | Good Clinical Practice (GCP), Good Laboratory Practice (GLP)
Milton V. Marshall, PhD, DABT, CCRP, President, Marshall & Associates Abstract: Preclinical testing of investigational pharmaceuticals, medical devices, and biologics is necessary before human subjects can be exposed to them. Many similarities exist...
