Infrastructure Data Management
- Capabilities		 Biostatistics
- Capabilities		 Statistical Methods

Reliance’s Biometrics Group encompasses the functions of Data Management, SAS Programming, and Statistics for all phases of the clinical trial. Our 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
  • SAS® 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

Our capabilities:
  • 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)

SAS Programming and Statistics

Our capabilities:
  • Sample size estimation and Justification
  • Statistical methods for protocol development
  • Randomization schedules 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
  • For BABE-Studies following services are provided
    • Pharmacokinetics (PK) and Pharmacodynamics (PD) analysis using Win-Nonlin
    • Statistical report writing
Bio Statistics and Programming:

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