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AUDITING SERVICES

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.


AUDIT SERVICES INCLUDE:

  • 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)