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.