Businesses - Clinical Research Services - Services - Biometrics


The Biometrics Group handles the functions of Data Management, Programming and Statistics (using R or SAS®) for all phases of the clinical trial. The Biometrics team has experience in handling projects in a large number of therapeutic areas. The Group has implemented CDISC standards and all processes are compliant with ICH guidelines.

Technical Infrastructure in Biometrics includes:

  • Oracle Clinical® - Our core Data Management system
  • R for Statistical programming
  • Adobe Frame Maker® for CRF designing
  • MedDRA for Adverse Event coding.
  • WHO-DD for medication coding.
  • Toad™ de facto standard Oracle development tool for reporting
  • Win-Nonlin® for PK/PD analysis
  • Customized applications for data tracking and analysis and reporting

Data Management

The capabilities are:

  • CRF Design, Printing, Distribution, Collection, and Analysis (CDASH compliant)
  • Global Library Creation and Maintenance as per CDISC/SDTM model
  • CRF Annotation and Review
  • Data Management Plan (DMP) Development
  • Database Design
  • Edit Checks Programming
  • Data Validation Specifications
  • Data Receipt, Logging, and Tracking
  • Data Entry
  • Query Management
  • Clinical Data Coding
  • Data Quality Assurance
  • Data Transfer
  • SAE Reconciliation
  • Data Management Reporting
  • Data Review Meeting
  • Electronic Data Transfer
  • Electronic Data Capture (EDC)

Programming and Statistics (using R or SAS®)

The capabilities are:

  • Sample size estimation and justification
  • Statistical methods for protocol development
  • Randomization schedule generation and management
  • Statistical Analysis Plan development for individual studies and ISS/ISEs
  • Programming of Statistical Tables, Listings and Graphs
  • Analysis dataset creation (CDISC, XPT and XML)
  • Interim and final analyses/Support DSMB or DSRB
  • Independent QC programming
  • Support for marketing
  • Exploratory and trend analysis
  • Analyses for manuscript preparation
  • Patient Profiling
  • Patient Narratives
  • Services for BA/BE-Studies
    • Pharmacokinetics (PK) and Pharmacodynamics (PD) analysis using WinNonlin
    • Statistical report writing

Biostatistics and Programming

The team has strong expertise in the full range of statistical methods:

  • Descriptive statistics
  • Linear and nonlinear models
  • Generalized linear models
  • Categorical data analysis
  • Time-to-event analysis
  • Nonparametric methods
  • Equivalence and non-inferiority methods data imputation

The statisticians and programmers have worked on protocols that are varied in size and complexity, across multiple therapeutic areas and study phases.