home_banner2
Biostatistics

Enabling scientists to take
data-driven decisions by
transforming data into science.

Slider
Home » SERVICES » Biostatistics

Differentiators

Proficency

15+ years of experience in the field of Biostatistics services

330+ projects executed

All phase of clinical trials, Non-Interventional Studies (NIS), FMCG and Real World Evidence (RWE)

Our core expertise

Statistical input to study protocol, design, DSMB/DMC, Interim Analysis, Statistical Analysis Plan (SAP) Randomization

SAS programmers with wide therapeutic area experience along with Statistical Programming services

Compliance and Quality assurance

Compliance with current industry standards and regulatory guidelines/ requirements

High quality biostatistics deliverables

CDISC Submission Format

Adaptability and efficiency to comply with CDISC format

Biostatistics and Programming service offerings

Biostatistical Services
  • Statistical inputs to control
  • Sample size estimation
  • Randomization for open label and  blinded studies
  • SAP develoment
  • Statistical analysis for trial data
  • Support for DSMB/Interim Analysis/BDR activities
  • Full DMC support, including preparation of the DMC charter
  • PK and PD Analysis
  • Interpretation of results and input to clinical study reports
Statistical Programming
  • Writing SAS edit checks for data validation
  • Programming analysis datasets
  • Reporting of statistical  analysis results (TLFs)
  • Programming of CDISC deliverables

CDISC Programming/Legacy Data Conversion 

  • CRF annotation
  • SDTM and ADaM specification creation
  • Programming of SDTM and ADaM datasets
  • Generation of define.xml
  • CDISC complaint deliverables
Business Intelligence & Data Analytics
  • Pharmaceutical sales analytics
  • Supply chain analytics
  • Risk based monitoring
  • Dashboard reporting