You Expect Quality

We Deliver a Never-Ending
Continuum of Standards

Providing the bedrock on which your outsourcing is based is ICH E6/R2. Harbor Clinical provides peace of mind as a deliverable in ensuring that your outsourcing partners are implementing quality control and quality assurance measures so that your trials are conducted and data are generated, documented (recorded), and reported in compliance with the protocol, GCP, and the applicable regulatory requirement(s)

  • Global GCP, GLP, GMP audits
  • Gap Assessments
  • Design and implementation of Quality Management Systems
  • System Validation Services
  • Regulatory Inspection Readiness, Training
  • Customized QA Solutions
  • Vendor Qualification Audits
  • Site Audits

Bringing peace of mind that your team and your partners are adhering to GxP guidelines; ensuring the delivery of clinical data that is accurate, complete, and meets all regulatory requirements.

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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