Academic Office of Clinical Trials

Dr Helekar placing magnetic stimulation device on patients head

Pauline Todd, MBA, BSN, RN
System Director
Director of Research, Academic Office of Clinical Trials and Cockrell Center for Advanced Therapeutics
ptodd@houstonmethodist.org
713-441-3242

 

Raquel Bunge
Clinical Trials Manager, Academic Office of Clinical Trials and Cockrell Center for Advanced Therapeutics
rrbunge2@houstonmethodist.org
713-441-3912

At Houston Methodist, we provide leadership for clinical trial operations through the Academic Office of Clinical Trials. Our dedicated staff offers resources to new and experienced investigators to enable them to conduct innovative clinical research.

 

 

When it comes to clinical research, our goals are fourfold.

 

 

  • We want to provide investigators with experienced and certified research coordinators and regulatory personnel who can give researchers internal and external support in their research
  • We serve as an effective liaison between investigators and industry sponsors
  • We attempt to promote the growth and development of our staff responsible for coordinating clinical trials
  • We pursue efficient integration of clinical research operations throughout Houston Methodist

 

 

 

Scope of our research services is broad and provides regulatory, research coordination and financial support.

 

Regulatory Support
  • Institutional review board (IRB) submissions
  • Informed consent preparation
  • IRB amendments
  • Regulatory document preparation and management
  • Investigational New Devices (IND) and Investigational Device Exemptions (IDE) applications
Financial Support
  • Cost assessment
  • Study budget preparation
  • Study budget negotiation
  • Invoicing
  • Financial reporting
  • Reconciliation of the study cost center
Research Coordinator Support
  • Study feasibility
  • Study initiation
  • Investigator 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

 

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