The VCC strives to provide comprehensive support for clinical and translational research projects.  In addition to serving as a “one-stop-shop” for clinical and translational research needs, the VCC also provides flexible project support (i.e. the option to select services as needed).  Investigators requiring focused support for specific needs as well as those requesting full project support can all be accommodated by the VCC.  

Services & Rates 2018

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Multicenter Clinical Trials Support

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 experience staff insures that each trial is tailored to produce sound scientific data.

Protocol Development

VCC Research Navigators are experts in investigator initiated projects, partnering with the investigator to carry the vision for the clinical trial to fruition. Planning each step of the project, identifying feasibility, and workflow optimization are just a few of the services that the VCC can provide.

Data Management

Using REDCap, databases are customized for each individual project. Data is entered remotely and source documents can be uploaded for data verification. Data verification can be customized for specific data points or through 100% verification. With off-site monitoring, data is reviewed in real-time and queries are issued for quick resolution. Projects are assigned a Data Analyst that is available for sites with urgent requests. Investigators also have the option of having a hotline for the VCC staff to be available for database and enrollment issues 24/7.

Clinical Trial Management

Once the protocol has been developed, our team of experts can support the oversight and full management of the project. This may include interactions with safety committees, participating sites, and industry or foundation sponsors and their representatives. Through continued site engagement, successful recruitment and retention, and can do approach; our team has a proven success in effective trial management.

Budget Development

The VCC has dedicated financial and accounting analyst to help properly project expenses for a variety of projects. From multicenter budget development, to local site proposals, our analysts are in compliance with federal, state and local regulations governing billing compliance.

Compliance

With the FDA’s guidance, the VCC works to maintain compliance with all regulatory authorities and laws through the E6 and Good Clinical Practices. The VCC will assist and offer consultation for agency audits and will comply with all IRB, sponsor, and other institutional reporting guidelines.

Participant Recruitment

Utilizing existing internal relationships with community engagement teams, ethicists, and human protection programs, we are able to leverage unique ways to engage participants. Consulting experts with a vast understating of studies are able to communicate effectively with our academia, industry, and foundation partners to maximize trial success.

Financial Management

Dedicated oversight of expenditures throughout the trial are assessed through our customizable financial management system. Real time reports are provided to investigators and departments to provide transparent and identifiable reconciliation of study finances.

Informatics

Vanderbilt has a strong history of creating customizable tools to increase clinical workflow, and research integration. The Synthetic Derivative (SD) is a database containing clinical information derived from VUMC’s medical record. This de-identified data allows for real-time patient population metrics for accurate enrollment estimations in addition to countless other research operations. REDCap is a CFR 21.11 capable, secure web application designed for building and managing online surveys and databases. REDCap is capable of generating automated data exports and provides seamless data integration with statistical software packages. This intuitive, flexible software allows for high levels of user customization without the need for experienced programmers, passing on the savings to both Vanderbilt researchers and industry supporters. (select the logo for more information)
redcap

Publications

The VCC partnered with institutional resources can help review manuscripts that are near completion. The VCC can help to guide Studio support for review and suggestions for edits to maximize journal acceptance. The Editor’s Club at Vanderbilt additionally can review manuscripts, posters, and abstracts. This is available to VUMC faculty, postdoctoral fellows and graduate student authors.

Protocol Training Materials

Tool development is customizable based on your clinical trial needs. Our team can provide services for multicenter education for various study related training. Tools are created to maximize workflow, built with intuitive features to help guide study personnel and prevent deviations. Our team also provides remote training opportunities to study personnel, making training more economical for the study, and efficient for the team. Training can be done through videos, or previously recorded webinars, or in real time webinar presentations. As study teams can often transition, this helps to properly train new study team members and expedite study enrollments.

Outreach

The VCC is specialized in developing the investigator’s vision for their focused research interest. Supporting investigators though navigating bench to bedside protocols, the VCC will help to funnel ideas into a viable and successful scientific questions. Continued communication with investigator will help foster growth in the investigator’s overall research portfolio.