A Global CRO

 

quality assurance

At Amarex, the Quality Assurance (QA) team interacts directly with our clients to understand the specific requirements for their product development project. Our quality and regulatory affairs specialist ensure adherence to these requirements and any applicable regulations from the U.S. Food and Drug Administration (FDA), Canada's Health Products and Food Branch Inspectorate, European Union, ANVISA and other international agencies during each phase of the clinical trial process. Our service comply with Good Clinical Practices (GCP), Good Laboratory Practices (GLP) and International Conference on Harmonization (ICH) GCP guidelines (E6).

For continual improvement, our team measures, assesses and reports quality data and seek ways to continually improve quality performance and results. According to industry best practices, our corrective and preventive action (CAPA) process ensures we investigate significant out-of-specification events, deviations and discrepancies, report the findings and conclusions of the investigation and implement and document corrective actions. We maintain preventative maintenance and calibration programs, as applicable, to ensure operational equipment is appropriately maintained and operating as defined.

Our senior-level auditors conduct unbiased assessments of all aspects of a study, including auditing clinical sites and associated databases, vendors, validating software, and assuring the quality of individual reports, study files, tables, and listings. They can also provide training to prepare investigator sites for actual regulatory inspections. Because of our global footprint, we have personnel fluent in twelve major languages and have conducted quality assurance audits in more than 45 countries. Our services include:

  • Auditing: investigator sites, clinical and analytical laboratories, drug packing and distributors, IRBs. Phase I unites and suppliesr/vendors
  • Validation of databases and computer systems
  • Review of study documents such as protocols, CRFs, clinical study reports, study files
  • Clinical site, manufacturer site and laboratory audits - GCP, GMP, GLP
  • Assistance preparing responses to inspection findings