Biometrics and Data Management
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Biometrics and Data Management

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:

  • Study experimental design
  • Case report form development
  • Case report form user guide development
  • eCRF designing and development for VCROCTIS EDC module
  • Randomization list generating program coding
  • Data management plan & report writing
  • Database creating & validation (Oracle database, SQL server database, SAS databset)
  • Audit trail designing and maintenance
  • Data double entry & databases comparison
  • Data validation rules (= data validation plan) development
  • Data validation rules programming & validation
  • Data coding
  • Data audit
  • Data cleaning (Queries generation & resolution)
  • Database locking, unlocking, & relocking
  • Database transferring
  • Interim data cleaning and output (interim analysis and/or DSMB data review)
  • By subject listing
  • Statistical consultation
  • Sample size / Power calculations (nQuery Advisor, SAS)
  • Statistical analysis plan writing
  • Blind reviewing and pre-analysis meeting
  • Statistical analysis programming & validation
  • Statistical analysis results outputs (tables, figures, listings) and interpretations
  • Statistical report writing
  • Interim statistical analysis
  • Data warehousing / Data mining

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.