The Biostatistics and Data Management Core was created in the summer of 2003 as an outgrowth of the Division of Biostatistics and Epidemiology. At that time the biostatistics unit and the data management unit were merged into a single comprehensive core facility charged with providing analytical, data management and information technology support to investigators throughout the Hospital. The BDMC currently has two broad subcores in its administrative structure.
Biostatistics: The biostatistics subcore has approximately 10 statisticians and statistical programmers at the doctoral and master's levels. In addition to study design and analysis, core biostatisticians are able to help researchers with statistical analysis plans, publication and grant application support, sample size estimations and centralized randomization services. The BDMC biostatisticians also collaborate and interact with members of the CHOP Biostatistics Faculty on grant applications and the design and analysis of research projects.
Data Management/Information Technology (DM/IT): The DM/IT subcore has approximately 10 staff members consisting of data managers, database analysts, data entry personnel and systems support staff. DM/IT services include CRF and eCRF design, data project management, database design and implementation, data management, data entry and data quality assurance and reporting. The DM/IT subcore currently provides traditional CRF-based trial services as well as web-based electronic data capture for CHOP investigators, permitting distributed data entry for investigator-supported research. IT personnel are available to support all Biostatistics and Data Management Core-sponsored projects.
The Biostatistics and Data Management Core has access to state of the art computing resources capable of supporting studies ranging in size from one to more than 100,000 subjects. The equipment is fully supported by the Research Information Systems group at CHOP and has complete business continuity and disaster recovery via redundant, distributed data centers and backup processes.
The IT staff can support development in SQL based databases, as well as web systems such as Coldfusion and .net. In addition, technologies are available to help projects identify technical solutions to project needs.
For trials of significant size or those requiring 21 CFR Part 11 compliance, the core utilizes Oracle Clinical TM, a clinical database management system (CDMS) designed specifically for use in FDA regulated trials. Oracle Clinical TM provides a highly secure environment with full data management functionality including built-in data cleaning and validation tools, clinical coding tools and external data integration capabilities. Oracle Clinical TM is a widely recognized and respected CDMS that is used in many trials by the National Institutes of Health and other agencies worldwide.
In addition to traditional office and project management software, BDMC staff have access to the following commercially available software packages for statistical analysis, sample size calculations and datafile conversions: Amos, LogXact, SAS , SPSS, S-Plus, STATA, StatXact, SOLAS, SUDAAN, CART, EAST, nQuery Advisor, Power and Precision, NCSS PASS, DBMS, WESSAMP (for stratified systematic sampling), WESSUPP (for supplemental sampling), WesVar (for analysis of data from complex surveys), and WesDaX (a web-based, statistical reporting tool).
In 2008, Westat assumed responsibility for operating the Biostatistics and Data Management Core. Westat's Clinical Trials Study Area (based in Rockville, Maryland) provides oversight, backup, and support to the BDMC as needed.
Westat, an employee-owned company, has more than 30 years of experience implementing clinical trials, epidemiologic, and other health studies for the National Institutes of Health, the Centers for Disease Control and Prevention, foundations, and pharmaceutical companies. Westat's Clinical Trials Study Area has approximately 400 staff members, including: approximately 145 database developers and data managers; approximately 30 PhD and Masters-level biostatisticians, epidemiologists, trialists, and statistical programmers; and approximately 35 information technology specialists, who in turn draw on Westat's 500 IT professionals as needed.