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.

We CAN ASSIST INVESTIGATORS AND STUDY TEAMS WITH ALL ASPECTS OF THEIR TBI-RELATED CLINICAL TRIALS, INCLUDING: 

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 
  • Case Report Form Development/Electronic Data Capture Support
  • Safety Monitoring Plan
  • Quality Management Plan
  • DSMB Coordination
  • Sponsor Study Close-Out Plan 
  • Training

Regulatory Compliance and Operations

  • eIRB Guidance
  • Regulatory Strategy
  • IND or IDE Application Support
  • clinicaltrials.gov
  • Essential Documents/Regulatory Binder
  • Regulatory Reporting

Monitoring

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

 

MTBI2’s Clinical operations division has unique expertise and extensive experience, including: 

  • Clinical research within U.S. military and civilian populations
  • Department of Defense and Federal Regulations
  • United States Food and Drug Administration (FDA) Regulatory Affairs
  • International Council of Harmonisation (ICH) Guidance

     

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

What Some of Our Previous Collaborators Have Said About The team:

“My experience working with MTBI2’s Clinical Trials Unit has been nothing short of excellent. The team has been extremely helpful with planning and walking our team through the process. Their expertise has been invaluable to me as a practicing clinician!”
CAPT Scott Klimp, Director | Fort Liberty Intrepid Spirit Center
 
"I have found MTBI2 to be an excellent collaborator. Their research interests closely align with ours, resulting in a natural partnership. They bring exceptional experience and support to all efforts. On a personal level, they are a pleasure to work and interact with."
Dr. Wesley R. Cole, Neuropsychologist / Research Lead / Section Chief | Fort Liberty Intrepid Spirit Center
 
“My experiences with MTBI2’s Clinical Trials Unit has been exemplary. I am the Site Primary Investigator on three studies with MTBI2 and this team has made what can be a very involved and timely process into as straightforward and painless as possible. They are willing to go the extra mile to help with all aspects of the work. I cannot thank them enough.”
Dr. Sean C. Sebesta, Chief | Department of TBI, Fort Bliss Intrepid Spirit Center