Goal

The Vanderbilt Coordinating Center offers Investigator Initiated Trial support to investigators engaging in expanding their studies to sites on national and international platforms. Through the expertise of the VCC’s Project Managers, investigators are able to conduct their studies with new and innovative technology.

Our team excels in creating projects focused on maximizing site support, successful recruitment, and quality reporting, all in an economical model. By incorporating the FDA’s guidance for remote  monitoring, and having the infrastructure and tools in house, such as REDCap, our experienced staff insures that each trial is tailored to produce sound scientific data.

Overview

Our Project Managers are able to connect with sites in a unique way as they have served as clinical research coordinators, and can help navigate sites through IRB submissions, leveraging tools to help support expedited contracting, and help navigate recruiting strategies.

Services

Our team hosts many services that can be customized to each Investigators’ project. Our team experts will help guide each investigator through services to create a tailored project plan.

  • Services offer could include:
  • Protocol development
  • Statistical support
  • Randomization schedules
  • Database design
  • Source verification
  • Traditional on-site monitoring
  • Off-site remote monitoring
  • Regulatory support
  • FDA assistance
  • Budget development and negotiations
  • Site payments
  • Site selection
  • IRB support
  • Assistance in committee formation
  • DSMB services
  • Project newsletters
  • Poster and pocket card creation
  • Audit preparation
  • Data management
  • Protocol and EDC training
  • Site initiation
  • Site close out

Highlighted VCC Managed Investigator Initiated Clinical Trials

feat

This trial is being conducted in order to compare angiographic outcomes in patients receiving 0.014-0.0155″ platinum framing and filling coils (larger diameter coils) versus those treated solely with coils less than 0.014″ (with a standard diameter).

NCT: https://clinicaltrials.gov/ct2/show/NCT01655784?term=FEAT&rank=1

positive

Perfusion Imaging Selection of Ischemic Stroke Patients for Endovascular Therapy is an interventional randomized study. Acute Ischemic stroke patients are randomized between mechanical thrombectomy or best medical therapy within 6-12 hours from symptom onset.

NCT: https://clinicaltrials.gov/ct2/show/NCT01852201?term=POSITIVE+MUSC&rank=2

Krista Vermillion
Division Manager
Stephanie Smith
Senior Clinical Research Navigator
Jessica Marlin
Clinical Trial Operations Manager
Bryan Cawthon
Clinical Research Data Specialist
Ally Qi
Clinical Research Data Specialist
Stephanie Stoops
Clinical Research Data Specialist
Lilyanna McArthur
Clinical Research Projects Coordinator
Sheri Dixon
Senior Clinical Research Navigator
Judy Jenkins
Clinical Research Navigator