You Expect Results

We Deliver a Never-Ending
Continuum of Quality

From start-up to study close-out, your operational needs can be supported with a team of Harbor Clinical professionals who understand the regulatory role they play to ensure you are compliant in all functions, including:

Study Startup Services:

  • Recruiting investigational sites
  • Supporting regulatory affairs group with regulatory authority submissions
  • Coordinating IRB/EC approvals
  • Collecting and reviewing initial essential documents
  • Closing investigator contracts (clinical trial agreements)

In-house Site Management Services

  • Reviewing and processing site documents in eTMF
  • Assisting with site queries
  • Tracking clinical activity status
  • Tracking and assisting with data queries
  • Providing support to CRAs and lead CRAs

Monitoring Services

  • Site qualification visits
  • Site initiation visits

Case Study:

An emerging immuno-oncology biotech entering Phase 1 was seeking a strategic partner in its plan to begin development.


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