- Institutional review board (IRB) submissions
- Informed consent preparation
- IRB amendments
- Regulatory document preparation and management
- Cost assessment
- Study budget preparation and negotiation
- Financial reporting
- Reconciliation of the study cost center
Research Coordinator Support
- Study feasibility
- Study initiation
- Sponsor meetings
- Subject screening
- Subject enrollment
- Subject follow-up
- Specimen collection
- IP accountability
- Data collection
- Case Record Form (CRF) completion
- Clinical Trials Management System (CTMS) entry
- Monitoring visits
- Study closeout
Our clinical research services core offers three distinct facilities to fulfill the data requirements of clinical trials needing approval by a regulatory agency.
- The Academic Office of Clinical Trials provides resources for conducting innovative, sponsored clinical research, including regulatory coordination, integration of research operations, liaison services to industry sponsors, and staff development opportunities.
- The Cockrell Center for Advanced Therapeutics promotes and supports clinical research operations at Houston Methodist. A full range of outpatient clinical care and study management services includes regulatory submissions and budget management support.
- The Cockrell Center Phase 1 Unit conducts early phase clinical trials. Facilities include exam rooms, private infusion rooms and a lab specimen processing area. The unit’s staff specializes in research nursing and coordinating services for client-sponsored projects.
The Clinical Research Services Core delivers excellence in standards of care and research integrity for client-sponsored clinical trials, focused on yielding rigorous data for regulatory agency review.