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For Investigators
- Study Startup & Clinical Operations Management - Coordinated guidance from concept to activation, ensuring a smooth launch.
- Budgeting - Accurate, strategy-driven budgets aligned with institutional and sponsor expectations.
- Research Coordination - Experienced clinical research coordinators provide day-to-day support for protocol implementation, including participant scheduling, data collection, regulatory documentation, and communication with sponsors and study teams.
- Regulatory Support - Expert navigation through IRB submissions, compliance requirements, and documentation.
- Feasibility - Clear, data-informed evaluations to determine protocol fit, resource availability, and enrollment potential.
Scope of Services
Phase I, Ila Studies Phase llb-lV Ancillary Services - First Time in Human Safety/Tolerance
- Pharmacokinetics (PK)
- Pharmacodynamics (PD)
- PK/PD Correlations
- Pharmacogenetics
- Clinical Safety and Efficacy
- Dose Ranging and Dose Definition
- Labeling and Claims Support
- Post Marketing Surveillance
- Protocol Preparation
- Study Design
- Source Document Form Design
- Database design
- IRB Preparation and Submission
- Budget Analysis and Negotiation
- Study Coordinator Effort
- Category B Devices
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For Sponsors & CROs
Systems currently utilized at our institution include:
- IRAP – electronic research administration system (New system coming soon 2026)
- Cerner – EMR system (EPIC coming soon February 2027)
- i2b2 – de-identified repository of health information, used for finding patients meeting certain criteria
- OnCore – clinical trials management system
- REDCap – scheduling & data entry
- Florence – eRegulatory binder service
Our team has access to multiple facilities and equipment that offer clinical research support:
- CH20 (Community Health Services Building 20): Administrative hub supporting public health initiatives and research coordination efforts.
- UAB Hospital: Supports inpatient clinical trials with full integration into UAB’s academic medical infrastructure and billing systems.
- The Kirklin Clinic (TKC): Major outpatient center enabling research in routine clinical workflows across 30+ specialties.
- UAB Hospital–Highlands: Acute-care facility supporting research through coordinated services and integrated hospital systems.
Community health care partners
- CCTS Research Support: Coordinated capacity, physical space and expertise, including:
- FibroScan: Liver elastography scheduling and service through the CReSt.