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ARA Quality Management System

independently run, rigorously tested

ARA’s rigorous Quality Management System (QMS) encompasses both quality control and quality assurance, defining the organizational structure, responsibilities, processes, procedures, and resources for implementing quality management. QMS is employed throughout all facets of ARA and includes managing and updating Standard Operating Procedures (SOPs); utilizing best practices to increase quality in output, systems and processes; providing universal training to all employees; employing Risk-Based Quality Management (RBQM) and root-cause analysis to drive higher efficiency and effectiveness; hosting and conducting audits of vendors and clients; and ensuring compliance with the General Data Protection Regulation (GDPR); the Food and Drug Administration (FDA) regulations related to Good Clinical Practice (GCP) [i.e. 21 CFR Part 11] the International Council for Harmonisation (ICH) guidance for GCP [i.e. ICH E6] and the International Organization for Standardization (ISO) standards for GCP [i.e. ISO 14155].

ARA’s QMS is based on Good Clinical Practices (GCP), Good Documentation Practices (GDP) guidelines, and industry standards for data management in clinical trials.

We believe that process-monitoring is one of the paths to continued improvement, success, and client satisfaction.

ARA’s Quality Systems Manager is independent of all project work and reports directly to the ARA President.

ARA’s dedication to internal quality is also a reflection of our commitment to the quality of our client-related work.

Rigorously tested; quality data you can trust.