Overview

HeaDS endorses Quality by Design principles applied to all functions of clinical research in alignment with FDA’s key initiative for modernizing trial oversight. To that effect, our Quality Assurance department comprises of highly trained scientists and pharmacists who establish integrated management plans to ensure that quality is built into the strategic, operational, and scientific level.

Our cross-functional approach provides more formal opportunities for the team to systematically discuss, assess, and measure quality according to international standards. This way we assure that clinical trials adequately safeguard patients and provide reliable data.

HeaDS heightened awareness allows stakeholders to take greater ownership of quality in any clinical research project.

Services

Services

Quality planning

  • Development of Standard Operating Procedures
  • Identification of Critical Quality factors
  • Risk mitigation strategy
  • Development of study specific Audit Plan
  • Vendor Qualification

Quality improvement

  • Continuous Risk Management review and adjustment
  • Response to quality issues with appropriate CAPAs
  • GCP Training

Quality control

  • Continuous oversight of Key Performance Indicators and Metrics
  • Continuous vendor evaluations throughout the project
  • GCP site audits

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