Clinical Operations Division

MTBI2’s Clinical Operations Division provides a full range of clinical trial support services to internally funded and collaborative research projects. They assist investigators and study teams with all aspects of their traumatic brain injury-related clinical trial, from project proposal to study close-out and publication. 

MTBI2’s Clinical Operations division has unique expertise and extensive experience, including clinical research within U.S. military and civilian populations, Department of War and Federal Regulations, United States Food and Drug Administration (FDA) Regulatory Affairs and International Council of Harmonisation (ICH) Guidance. 

We can assist investigators and study teams with all aspects of their TBI-related clinical trials.

 

Protocol Development & Operations

  • Proposal Support (Budgeting/Agreements)
  • Site Identification and Qualification; Site Staffing/Management
  • Protocol Development (protocol and consent documents) 
  • Trial Feasibility Assessment

Trial Start-Up and Close-Out Activities

  • Manual of Operating Procedures
  • Standard Operating Procedures
  • Recruitment and Retention Strategy Plan 
  • Outreach and Recruitment Consultation
  • Safety Monitoring Plan
  • Quality Management Plan
  • DSMB Coordination
  • Sponsor Study Close-Out Plan 
  • Training

Regulatory Compliance and Operations

  • eIRB Guidance
  • Regulatory Strategy
  • clinicaltrials.gov
  • Essential Documents/Regulatory Binder
  • Regulatory Reporting

Monitoring

  • Remote & On-Site (Site Initiation, Monitoring and Close-Out)
  • Risk Based Monitoring Plan

 

Interested in working with our Clinical Operations Division? Contact MTBI2-cod@usuhs.edu for more information about its capabilities. Regulatory inquiries should be made to MTBI2-reg@usuhs.edu.