Services

Biostatistics Services

The mission of the biostatistics team is to provide consultative and analytic support services to investigators interested in basic, pre-clinical, clinical and epidemiological pediatric studies. Our biostatisticians may serve as the protocol statistician on clinical trials and participate as protocol team members.

The biostatistics team offers the following services:

  • Study Design (from pre-clinical, basic science to multi-site clinical trials and observational studies)
  • Randomization
  • Sample size and Power Calculations
  • Statistical Analysis (planning, data analysis and report writing)
  • Statistical Analysis for Data and Safety Monitoring Boards (DSMB)
  • Statistical Support for Grant Applications
  • Statistical Support for Abstracts and Manuscripts
  • Statistical Methodological Research
  • Free Statistical Consulting

Click here to see a selection of publications, presentations, and abstracts co-authored by BDMC staff.


Data Management/Information Technology Services

The data management/information technology team provides a selection of services including case report form development, single or double data entry, data review, discrepancy checking and resolution, and quality assurance audits. Data management software and activities are conducted according to standard operating procedures

The level of involvement ranges from consultation through full-service data management. The data management/information technology team offers the following services:

  • Database Development and Maintenance using Oracle, REDCap, SQL Server and other database tools
  • Web-based Systems for data capture and study operations
  • Case Report Form (CRF) Design (paper and electronic)
  • Data Entry (single or double data entry) and Document Imaging
  • Data Review, including query generation and resolution
  • Audits to ensure accuracy and quality of study data
  • Creation of Analytic Datasets (e.g., SAS and SPSS)
  • Data management systems and documentation that meet regulatory requirements (e.g., FDA, Part 11, CDISC/CDASH compliance)