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ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors.
Safeguarding patient safety and data integrity by maintaining strict regulatory compliance with an emphasis on immediate risk mitigation and inspection readiness.
ERG’s Quality Assurance function provides clinical sites with the standardized operating procedures (SOPs), systems, tools, and best-practice guidance needed to support consistent, compliant study execution and the delivery of clean, reliable data. Through centralized resources and cross-site standardization, Quality Assurance helps equip sites with clear processes and operational frameworks that promote efficiency and consistency. Executive management oversees these activities, and internal committees meet regularly to identify opportunities for process improvement. ERG’s centralized quality assurance procedures and policies are aligned with all required regulations and best practices such as the Food and Drug Administration (FDA), International Council for Harmonisation (ICH), and the U.S. Department of Health and Human Services (HHS), and others when applicable.
ERG’s technology environment is architected to meet the demands of regulated clinical research and enterprise scale operations. Our platforms create the framework of our operations:
An electronic Quality Mangement System (eQMS)
Electronic Investigator Site Files (eISF)
Clinical Trial Management System (CTMS)
Quality Control is implemented in ways that provide meaningful oversight based on a clinical trial sites practices or protocol design. Quality Management Plans or Quality Management Work Instructions ensure site staff adhere to specific quality control checks that confirm that the data generated, collected, analyzed and reported is in compliance with the protocol, SOPs, and supporting regulations and guidelines. Quality Control efforts not only ensure accuracy but keep a pulse on identifying opportunities for training, process improvement, and reporting any observations or trends to the Quality Assurance team for further event investigation and management.
ERG’s mission is to provide the highest quality clinical trial execution across all clinical research phases to help sponsors.
