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

 

 

GENERAL INQUIRY
Corporate Headquarters
800.431.9640
330.278.2343
info@clinicalrm.comFederal Services Operations
301.620.1987
info@clinicalrm.comInternational Operations
800.431.9640
info@clinicalrm.com

 

DRIVING DIRECTIONS