About the Clinical Trials Studio

The Clinical Trials Studio is an initiative supported by a multidisciplinary team of accomplished clinical trialists aiming to assist UTMB investigators with beginning and refining their clinical trials. We assist researchers at any career level, and we provide feedback on trials at any stage of development.

Investigators interested in performing a clinical trial at UTMB are encouraged to attend the Studio should they need assistance in any step of the process, including:

  • Incubation
  • Study Framework
  • Budgeting
  • Hypothesis Formulation
  • Protocol Development
  • Consent Form Development
  • Biostatistics/Statistical Planning
  • Ethical Considerations
  • IND/IDE Development
  • Submitting to the IRB
  • Addressing IRB Stipulations/Obtaining Final Approval
  • Post-Approval Procedures (e.g., Recruitment, Retention, etc.)

Kathleen Vincent, MD
Director of the ITS Clinical Trials Studio

For more information about Clinical Trials Studio consultations, please visit the Submitting a Research Project page.