Study Design

  • Statistical Methods

    We have substantial biostatistical expertise in the design, conduct and statistical analysis of observational studies and clinical trials. This includes traditional designs and modern variations, such as one using a sequential multiple assignment randomization trial (SMART) design.

  • Sample Size and Power

    When determining whether a proposed study is feasible and ethical, sample sizes with adequate statistical power are crucial in yielding definite results. Our biostatisticians are highly skilled at sample size and statistical calculations.

Data Analysis and Reporting

  • Scientific Presentations and Manuscripts

    Our faculty and staff statisticians collaborate with investigators to prepare scientific presentations and manuscripts, undertake the appropriate statistical analyses and contribute to the writing of the manuscripts.

  • Masters Papers and Doctoral Dissertations

    Faculty at the CSCC frequently serve as advisors for masters papers and on doctoral dissertation committees.  For biostatistics doctoral dissertations, this is typically to help provide access to and expertise on real-world data.  For doctoral students from other departments, it is more for guidance with statistical aspects of their dissertation.

  • DSMB and Interim Analysis Reports
    The CSCC is an experienced provider of high quality, comprehensive reports on study safety and interim effectiveness for Data and Safety Monitoring Boards and other oversight groups. We have produced such reports for both NIH-funded studies conducted by the CSCC and industry-sponsored studies where DSMB reports are the sole need. We specialize in graphical presentation of study data based on state of the art ideas about human comprehension and scientific communication.
  • Data Visualization
    At the CSCC, important charts for regular study and clinic monitoring are implemented within views.  On a regular basis the data behind each chart is updated, so the chart automatically reflects the newest status.  By moving to online distribution of these charts, CSCC has not only reduced our dependence on paper, but has added a degree of interactivity and clarity to status reports that was previously unattainable.

Study Implementation

  • Risk-based Monitoring

    We use a risk-based system for monitoring clinical studies, improving efficiency as well as patient safety.  This method utilizes a combination of central monitoring and on-site monitoring, and focuses on the most critical monitoring activities for enhancing patient safety and ensuring quality data in a particular study.  Development of a clinical monitoring plan and an ongoing assessment of risks to patient safety and data quality are important components of our approach to risk-based monitoring.

  • Event Review and Adjudication

    Once health outcomes are classified by a team of nurse-abstractors and specialty physicians, our biostatistics and statistical computing groups summarize them to provide validated data for use in publications or reports.

  • Site Training and Coordinating

    The CSCC offers extensive services in creating training materials, manual of procedures, forms and question by question documentation, and planning and hosting training events.  We work together with sites and clinical coordinating centers to ensure that the protocol is rigorously followed by the sites and that data is correct entered.  Experienced members of our data management, statistical computing and research teams are on hand to provide you with the level of instruction needed to guarantee quality data collection for your research.

  • Case Report Form Design

    We work with study investigators to develop questionnaires and interviews with the goal of high quality data collection, as well as ease of use. We then design data entry screens from the paper instruments that include data validation, automatic skip patterns, and calculations, as needed.

  • Custom-Fit Data Management System Built to Your Needs: CDART
    Providing you with a flexible data management system customized to you and your study’s needs is what we designed CDART to do best. Tell us what you need, and we can apply CDART to it. CDART (Carolina Data Acquisition and Reporting Tool) is an enterprise-grade, scalable, web-based data management tool made for multi-center clinical trials, observational studies, and patient registries. We’ll work with you to customize the CDART data management system to meet your needs. Instead of changing your study to fit a system, we customize CDART to the needs of your study and your staff.
  • Quality Assurance and Quality Control
    In order to assure adherence to protocols, the Coordinating Center organizes training of field center staff.  CSCC conducts central training sessions prior to the start of study enrollment as well as having considerable expertise in laboratory quality control.