Services

The clinical research center offers a wide variety of services throughout the life cycle of a clinical trial. Services can be utilized in an a la carte or bundled manner to meet the needs of each unique study. Below are some of the most common services provided, but additional services may be available upon request. Learn more about our clinical research services.

Coverage Analysis

• Perform in-depth review of studies to verify conventional standard care vs. research only costs to identify what can or cannot be billed to a third party payer (either private insurance or Medicare).
• Develop the billing grid
• Request Clinical Trials Management System calendar build
• Perform a compliance review to ensure document alignment (i.e. billing grid, coverage analysis, consent form, budget)

Budgets

• Develop internal budget based upon coverage analysis findings
• Edit sponsor budget templates
• Budget review with departments
• Negotiate budgets
• Collaborate with contracting team on final budget

Regulatory

• Submit studies for IRB approval
• Coordinate institutional requirements
• Negotiate consent forms
• Assist with monitoring visits
• Maintain regulatory binders
  • Protocols
  • IRB application, amendments and continuing reviews
  • Licensures
  • Certifications (i.e. CITI, GCP)
  • CVs

Finance

• Invoice creation
• Payment reconciliation
• Subject stipend and/or travel reimbursement processing
• Clinical Trials Management System budget entry
• Multi-site IIT Payments to subsites
• Clinical trial financial reporting
• Internal forms submission

Clinical Services

• Study Coordination
  • Research Nurse Coordination
  • Research Coordination (non-nurse)
• Clinical Space
  • 3rd Floor University Tower
  • Global Center for Health Security 
• RA Services
  • Phlebotomy
  • Timed PK/PD Assessment
  • Urine Collection
  • Pregnancy Test
  • Specimen Processing & Shipping
  • Study Specific Assessments
    • Vital Signs: including height and weight  
    • ECGs
    • Spirometry
    • 6 Minute Walk Test
• Nursing Services
  
  • IV Draws
  • Port Draws
  • Central Line
  • Drug Administration
    • Infusions
    • Oral
    • Sub Q
    • Interdermal
    • Atopical 
    • Transdermal
    • IM
    • Inhaled
    • Eye Drops
  • NP Swabs
  • Post Drug Administration Monitoring

Cellular Therapy Support Service

The Cellular Therapy Support Service assists research teams interested in opening trials involving cellular therapy. Cellular therapy is the administration of engineered and/or expanded cells as a medicinal product to induce a therapeutic effect. Learn more details about this service.