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 24, 2024 | Professional Development, quality management, Uncategorized
Erika Stevens, MA, FACRP Faculty Lecturer Rutgers Clinical Research Management Principal Recherche Transformation Rapide LLC Liz Wool, FACRP, CCRA, CID, CMT President Wool Consulting Group, Inc. Abstract: The role of leaders in successful implementation of a workforce...
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 | Oct 28, 2019 | quality management
Abby Statler, MPH, MA, CCRPResearch Regulatory Quality Assurance CoordinatorCleveland Clinic Cancer Institute Abstract: In 2008, The Cleveland Clinic Cancer Institute established a quality assurance (QA) program for investigator-initiated trials (IITs). Over the past...
by SOCRA | Jul 18, 2019 | quality management
Vatché BartekianPresident, Vantage BioTrials, Inc. Abstract: Quality by design for clinical trials comprises an independent entity responsible for quality standards and an integrated system where each person is accountable for quality. This article explores myths...
