Biostats & Epi

Data Coordination Unit

Director:

Dr. Valerie Durkalski, PhD, MPH
Phone: 843-876-1911
E-mail: durkalsv@musc.edu
   

Location:

MUSC - 135 Cannon Street, Suite 303

Website:

http://dcu.musc.edu/

Description:

The Data Coordination Unit (DCU), housed within the Department of Public Health Sciences in the Department of Medicine at the Medical University of South Carolina, specializes in providing assistance with the design of clinical trials and analysis of their data and in establishing, implementing and maintaining data and project management systems for multicenter clinical trials.

The Unit is experienced with the design and conduct of Phase I through III trials in a variety of therapeutic areas including neurology, digestive diseases, psychiatry, and diabetes, as well as trials conducted under FDA Investigational New Drug applications.  Current clinical research studies involve over 100 academic institutions (including MUSC) in North America as well as international institutions. All data management activities for these studies are conducted using the DCU’s internally developed and validated Clinical Trials Management System (CTMS) referred to as the WebDCU™ system. The WebDCU™ offers a full collection of web-enabled modules for randomization, protocol and site management (e.g., drug accounting and shipping, automated SAE reporting, regulatory document tracking), study monitoring, data entry and validation, and report generation.

The system provides a web-based collaborative environment for study team members across all participating clinical sites and provides all the required tools for site coordination and data management in one efficient and easy to use system.    

Accessibility:

If you are in the process of planning a clinical trial particularly a multicenter trial, please feel free to contact DCU for potential collaborations.