CTU Services

The CTU can help you with all aspects of your clinical research study. Contact us to learn more!

Hire Dedicated Research Personnel

  • Regulatory Specialist
  • Start-up Specialist
  • Recruiter
  • Research Assistant
  • Research Coordinator
  • Project Manager

Fee for Service -- Contract with the CTU for Specific Tasks

  • Protocol Development
  • Study Start-Up Regulatory
  • Regulatory Submissions
  • Feasibility Assessments
  • Study Budgets
  • Project Development (Includes Protocol Development, IND determinations, feasibility consultations, CRO and vendor selections, vendor start-up management, consultation on regulatory items, etc. – especially for investigator-initiated studies)

Other Services

  • Recruitment Strategy & Advertising
  • Feasibility Assessments
  • Site Qualification Visit
  • Consent Development
  • Essential Regulatory Documents
  • Regulatory Binder
  • Source Documents & Trackers
  • Site Initiation Visit Training Slides
  • Mock Visits with Coordinators
  • Supplies and Sample Labels
  • Pharmacy Set-up
  • Clinicaltrials.gov
  • Monitor Plan, DSMB Charter, Lab Manual
  • Tools (best practices, guidance, process notes, etc)

Just-in-Time Services to active trial to enhance, boost or rescue the trial

  • Recruiter to maximize enrollment
    • Prescreening, calls, data mining, consulting
    • Good for well-funded competitive enrollment trials or lagging investigator-initiated trials
  • Coordinator to help run trial
    • Conduct study visits, enter back-logged data
    • Good for over-enrolling trials and unanticipated staff shortage
  • Research Assistant to free up time
    • Visit prep, labeling, filing, lab processing, admin work
    • Good for freeing up time for Coordinators to do higher-level tasks
  • Regulatory Specialist to do submissions & documents
    • Conduct folder & regulatory binder checks, help prep for monitor visits, targeted training
    • Good for high risk/high profile studies, junior teams or compliance issues