Quality is Our Common Denominator to Regulatory Compliance

Your Safeguard to Clinical Trial Success

As outsourcing continues to rise, so too has the number and accessibility of CROs. Outsourcing partners of various sizes and therapeutic alignment provide services running the full clinical development spectrum. Harbor Clinical understands that, regardless of the CRO resource used, per ICH E6/R2, Sponsors have the ultimate responsibility for quality and regulatory compliance on all submissions. Harbor Clinical’s oversight services are structured to incorporate quality control throughout the process overseeing QC checks at each step of data handling to ensure your success. We subscribe to “an ounce of prevention is certainly worth a pound of cure!” approach.

  • Facilitate Risk Assessments and mitigation strategies
  • Oversee Vendor and Site Audits for compliance
  • Develop Quality and Oversight Plans
  • Implement quality control procedures as identified in the risk assessments
  • Develop, document, and evaluate Key Performance Indicators
  • Manage Issue escalation and resolution
  • Provide resources for co-monitoring purposes, site audits, vendor audits, etc.
  • Conduct eTMF QC for completeness and accuracy
  • Support finance with CRO spend number and projection of cost to complete

Case Study:

A growing biotech company progressing into late-phase trials needed a partner to manage and conduct all audits.

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