Providing consulting services in all aspects of clinical data management, develop electronic case report forms (eCRF), develop query and reporting tools, and edit check programming. Development of data management plan (DMP), data review standards, and implementation of clinical systems security plans to meet data management study timelines.

Consulting Services: 

• Development, implementation, and maintenance of data exchange and transfer between Electronic Data Collection Systems and internal electronic tracking database systems.
• Develop and maintain 21 CFR part 11, regulatory guidelines, and IRB compliant databases (EDC).
• Develop electronic data collection systems (survey monkey, MS access, Qualtrics, redCap)
• Validation and user acceptance testing (UAT) for databases and eCRFs.
• Consult standards of practice and recommend appropriate strategies for database development to the center trial director and project managers.
• Perform statistical analyses such as descriptive analysis, univariate, multivariate analysis of variance, and regression analysis.
• Provide statistical analysis using statistical software packages in SAS and SPSS.
• Prepare reports to be submitted to funding sponsors, study leadership, and principal investigators relevant to publications in progress and monitor continuous progress in pending manuscripts.
• Consult on trial data management design, general supervision, and oversight of research projects.