Regulatory Affairs Study Start-up

    CTI’s global Regulatory Affairs Study Start-up team assists international sites with local and central IRB/EC submissions, and they practice proactive site management to ensure regulatory compliance throughout the duration of a clinical trial.

    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