Quality Assurance

ARI ensures your clinical studies are done right at every step of the way

ARI is extremely proud of the reputation for quality we have earned in the drug development industry over the past 18 years. ARI understands the requirements to make your clinical study a success. Our commitment to quality is represented by our Quality Assurance group, which plays an active role in each study to ensure regulatory and sponsor requirements are met.

All studies conducted at ARI as an investigator site are subject to the Quality System:

Standard Operating Procedures (SOPs) – ARI has a Global SOP system established and implemented across all clinical sites, which ensures systems and processes are uniform and controlled.
Employee Training – ARI employees are rigorously trained on Good Clinical Practices (GCP), Good Documentation Practices (GDP), applicable SOPs and protocol-specific training prior to conducting clinical activities. As part of our commitment to quality, ARI staff members attend industry conferences on a regular basis to keep abreast of regulatory and quality requirements.
Quality Control – ARI’s Quality Control group is unique, where our quality assurance group is separated from clinical operations and provides an independent, objective review of all clinical documentation and data. All source data generated from a clinical trial is QC’d for completeness as well as protocol and SOP compliance.
Auditing – Audits are conducted at various stages of the project according to a Quality Plan. Depending on the stage of the trial, ARI conducts the following types of audits:
- Vendor audit
- Pre-trial audit
- In-process documentation audits
- Trial close out audit
- Statistical audit
- Clinical study report audit