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