Clinical Services Regulatory Affairs Study Start-Up

Regulatory Affairs Study Start-Up

CTI’s global Regulatory Affairs Study Start-Up 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 Study Start-Up 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.

Roy Wells
Assistant Director, Regulatory Affairs Study Start-Up, North America
Roy has over 20 years of industry experience in quality assurance and regulatory affairs. His knowledge of global regulatory and quality assurance requirements, along with his ability to respond quickly to the needs of CTI employees, sponsors, and sites, have made Roy a strong resource in regulatory affairs.

Roy Wells

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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