Quality Management and Compliance

Our team approach to quality management and compliance begins in the implementation phase and exists within all systems and processes throughout the lifecycle of a program or clinical trial.  The approach includes the incorporation of standardization through education, written procedures, the establishment of defined metrics, and auditing.

We offer the following Quality Management and Compliance Services:

  • • Quality Management Plans
  • • Metrics for Performance and Compliance
  • • Onsite or Remote Independent Data Auditing
  • • 21 CFR Part 11 Compliance
  • • GLP, GMP, and GCP Consultation, Training, and Auditing
  • • Standard Operating Procedures
  • • Regulatory Master File Review
  • • Preparation and Facilitation of Third Party Audits
  • • Site GCP Audits
  • • Vendor Qualification Audits
  • • Research Readiness Assessment

 


 
AWARDS

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GENERAL INQUIRY

Corporate Headquarters 800.431.9640 330.278.2343 info@clinicalrm.com
Federal Services Operations 301.620.1987 info@clinicalrm.com
International Operations 800.431.9640 info@clinicalrm.com

 
DRIVING DIRECTIONS