Quality Management System

ARA – Turning Trials into Triumphs

At ARA, we understand that your clinical trial may face unique challenges. Our goal is to provide the expertise, experience, and customized service necessary to overcome these challenges so you can reach a successful result as efficiently and cost-effectively as possible. From Phase I to FDA approval, for drugs, devices, and biologics, your success is our goal.

ARA Quality Management System

ARA’s rigorous Quality Management System (QMS) is based on Good Clinical Practices (GCP), accepted Quality Management System guidelines, Good Documentation Practice (GDP) guidelines, and industry standards for data management in clinical trials. ARA employs a full-time individual in the role of Quality Systems Manager, who is independent of all project work and reports directly to the ARA President. ARA’s QMS is designed to continually monitor ARA’s policies, procedures, and processes, and to incorporate internal and external audit feedback. We believe that process monitoring is one of the paths to continued improvement, success, and client satisfaction. We are proud to have a fully documented and tested QMS that includes the following:

  • Version-controlled SOPs and Work Instructions
  • Training Program
  • Quality Manual
  • Quality Policy
  • Corrective and Preventive Action System (CAPA) Manual
  • Internal Audit System
  • Management Review of QMS and related findings
  • Trending Evaluation

ARA’s dedication to internal quality is also a reflection of our commitment to the quality of our client-related work. ARA regularly receives positive feedback surrounding the completeness of our QMS from existing and potential clients.