BioResearch Monitors, Inc.

 

Quality assurance and regulatory compliance services for

pharmaceutical and biomedical research and development

 

GOOD CLINICAL PRACTICES SERVICES

To ensure that scientific and ethical standards are met in the conduct of clinical trials, the experienced clinical scientists of BioResearch Monitors, Inc. use proprietary computer based audit tools .

To maintain independence and objectivity in the conduct of Quality Assurance evaluations, BioResearch Monitors, Inc. does not undertake the conduct or management of clinical trials.

 

 

Clinical Trial Quality Assurance services include:

  • Interim quality assessments of ongoing domestic and international clinical trials
  • Validation audits of completed clinical trials
  • Preparation of Clinical Sites for Regulatory Inspections
  • Due diligence audits of Contract Research Organizations (CRO), Site Manegement Organizations (SMO)
  • Independent QA assessments of CRO study management and CRO managed studies
  • Study file and regulatory documentation reviews
  • Drug accountability and reconciliation audits
  • Clinical Laboratory, Bioanalytic Laboratory and other Clinical Facilities assessments
  • Clinical supplies preparation, packaging and distribution audits
  • Data receipt, entry and reporting assessments
  • Clinical trial "Audit Certificates"
  • Final Report and Regulatory Submission Audits
  • Institutional Review Board (I.R.B.) evaluations