Clinical Services Regulatory Affairs

Regulatory Affairs

CTI’s global Regulatory Affairs team is experienced in assisting international sites with local and central Institutional Review Board (IRB)/Ethics Committee (EC) submissions, and they practice proactive site management to ensure regulatory compliance throughout the duration of a clinical trial. Our global Regulatory Affairs team has many years of industry experience, allowing for faster review of time sensitive documents, relationships with site regulatory staff, and faster approvals. Our team is familiar with the processes and required documents for local and central IRBs/ECs across the world.

Our global Regulatory Affairs team oversees:

  • IRB/EC submissions
  • Collection and maintenance of required site essential documents
  • Informed Consent Form (ICF) and Patient Information Form review
  • Electronic and paper Trial Master File (TMF) support

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