Clinical Trial Support

Clinical Trial Support2018-09-07T16:22:56+00:00

Regulatory Support

  • Institutional review board (IRB) submissions
  • Informed consent preparation
  • IRB amendments
  • Regulatory document preparation and management

Financial Support

  • Cost assessment
  • Study budget preparation and negotiation
  • Invoicing
  • 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.