You Expect Quality

We Deliver a Never-Ending
Continuum of Standards

It’s difficult to overstate the importance of data quality in clinical research. Scrupulous attention to detail in capturing, reporting, and interpreting data is vital to helping researchers draw valid conclusions, meet regulatory requirements, ensure patient safety — and realize the promise of new treatments and cures.

Harbor Clinical provides a broad portfolio of quality assurance services to ensure that investigators, staff, and vendors follow trial protocol, adhere to regulatory and good clinical practice standards, and collect and report data that is of the highest integrity. We’re committed to helping clients implement GxP strategies and programs that meet the requirements of the Food and Drug Administration, the European Medicines Agency, and the Medicines and Healthcare products Regulatory Agency.

Our highly experienced QA professionals have the expertise to implement programs, processes, and procedures that meet regulatory requirements and accelerate product development while minimizing risk and safeguarding patient safety.

  • Quality Management System development
  • Gap analysis and compliance assessment
  • SOP development
  • Inspection readiness
  • Audit preparation training
  • Mock inspections
  • GxP training
  • GxP quality assurance audits
  • GLP, GMP, GCP, and GVP audits
  • Clinical documentation
  • Clinical databases
  • TMF audits
  • Vendor qualification
  • System validation
  • For-cause audits

Case Study:

A global pharmaceutical company was seeking a Quality Assurance partner to conduct a Gap Assessment and assist with issue resolution and ongoing QA initiatives.

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