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.
Study Design
- Statistical Methods
- Sample Size and PowerWe have substantial biostatistical expertise in the design, conduct and statistical analysis of observational studies and clinical trials. When determining whether a proposed study is feasible and ethical, sample sizes with adequate statistical power are crucial in yielding definite results.
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
With regard to biostatistics doctoral dissertations, assistance is typically intended to help provide access to and expertise on real-world data. For doctoral students from other departments, we provide guidance with statistical aspects of their dissertation.
- DSMB and Interim Analysis ReportsThe 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 VisualizationAt 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.
- Experience with data standards
- Utilize best practices data sharing strategies
- Experience working with CDISC SDTM and ADaM standards
- Cloud-based Computing
Experience hosting image reading infrastructure using XNAT
Study Implementation
- Risk-based Monitoring
We use a combination of risk-based monitoring (RBM) and centralized monitoring (remote data review) approaches with occasional on-site visits for source data review (SDV) in our clinical monitoring. This improves efficiency as well as protects study participants by focusing on the most critical elements of monitoring activities to enhance participant safety and ensure quality of the data collected in our different studies.
- Event Review and Adjudication
We can classify medical endpoints for certain studies in a standardized manner with our team of professional nurse-abstractors and specialty physicians who review select data points and confirm actual diagnoses of interest. Both medical research teams are trained, certified and involved in quality control exercises to maintain the skills to do their work with the same approach, preventing possible bias in the data. Our biostatistics and statistical computing groups then summarize the results 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 correctly 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 DesignWe 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. Our in-house Form Designing tool is capable of building complex and customizable forms from the paper instruments.
- Custom-Fit Data Management System Built to Your Needs: CDARTProviding 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 ControlIn 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.
- Regulatory, including data use agreements and single IRB
- Data Collection Forms / CDART: Self-administered data collection options available