The CRC offers a wide variety of Clinical Research Services throughout the life cycle of a clinical trial. The CRC services can be utilized in an a la carte or bundled manner to meet the needs of each unique study.
Some of the most common services provided are:
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 (CTMS) 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
- CTMS 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 (UT)
- Global Center for Health Security (GCHS)
- 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
- For more details on this service, please see this link.
Additional services may be available upon request.