Overview

The Data Coordination Unit (DCU) is highly experienced with all aspects of multicenter clinical trials and offers full service statistical consulting ranging from protocol development to final analysis and report writing. DCU services include study design/protocol development, central registration and randomization, data management, web-based database system development, reporting and publications.

The DCU, housed within the Division of Biostatistics and Epidemiology 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.

The DCU is involved with several clinical research studies, most of which are NIH-funded, multicenter clinical trials involving 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.

Please view our website to find out more about our system and unit.