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.

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

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