Across studies from phase I to phase IV, it is essential and required to transform raw data that collected from individual subject who participated clinical trials, into useful information. The task described above is accomplished by our Biometrics & Data Management (BDMD) Team.
VCRO data management service is utilizing Oracle Clinical (OC) CDMS with Oracle database and VCROCDMS proprietary system using SQL Server database. Data standard can be in full compliance to CDISC (Clinical Data Interchange Standards Consortium) when needed by the clients. All data processing steps and data validations are tested, independently validated, and well modularized before use. Coding dictionaries commonly applied to data coding are MedDRA, WHODRUG, and ICD10.
All statisticians in VCRO BDMD team are well trained SAS programmers, enabling all statistical services to be provided by SAS. All statistical programs are validated and modularized before applying to individual analysis purpose.
A general list of BDMD services:
Since year 2010, VCRO also provides the data warehousing services to clients that the clinical trial data across different studies can be integrated for further data mining purpose based on the data standards of CDISC.