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