BioResearch Monitors, Inc.


Quality assurance and regulatory compliance services for

pharmaceutical and biomedical research and development



BioResearch Monitors, Inc. provides professional, independent, cost-effective quality auditing services related to FDA, ICH, ISO and related worldwide quality standards for good clinical practices (GCP), and related quality standards for pharmaceutical research and development.


  • Interim Quality assessments of ongoing domestic and international clinical trials
  • Validation audits of completed clinical trials
  • For-Cause audits to assess issues identified by monitors or sponsors
  • Preparation of clinical sites for regulatory inspections
  • Due-diligence audits of CROs or vendors to ensure that adequate systems are in place prior to study start 
  • Independent QA assessments of CRO study management and CRO managed studies
  • Study file and regulatory documentation reviews
  • Evaluation of Standard Operating Procedures (SOP's)
  • Assessments of management systems of Research and Development operations and research projects
  • Computer validation audits (CFR Part 11)