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Regulatory Affairs

What We Provide

Cancer Insight provides CRO services to support your research initiative. We help you design, execute, and assess your clinical research with a hands-on collaborative approach throughout the entire process. Our Regulatory Affairs Team ensures that the extensive and ever-changing regulations imposed by the FDA and other regulatory oversight bodies are proactively managed and that regulatory compliance does not pose any difficulties to your study. Our Regulatory Affairs Team can also organize and manage your study’s IRB requirements to ensure seamless compliance.

Regulatory Affairs Capabilities Include:

  • IND Application Management
  • Sponsor & FDA Correspondence Liaisons
  • SAE/Deviation Reporting and Tracking
  • Multi-Site Review and Management
  • Document Creation (IB/Protocol/Consent)
  • Regulatory SOP Development

From investigational new drug applications to the FDA to multi-site IRB oversight, our Regulatory Affairs Team provides consultation and management on the code of federal regulations and all other regulatory matters as they pertain to your study.