Biostatistics is at the heart of every clinical study (driving study design, study conduct, data collection, analysis, and reporting). The contemporary focus on evidence-based research magnifies strategic biostatistics needs. Biostatisticians and statistical programmers of COD Research apply scientific principles and therapeutic indication knowledge to support throughout the clinical study.
● Clinical Design: Adaptive Design, Sample Size Calculations, Randomization Plan
● Statistical Analysis: SAP Preparation, SAS Programming, TLF Generation, PK/PD Analysis
● CDISC Conversion and/or Deliverables (SDTM, ADaM, Define)
● Contribution: Protocol Development, DSMB/DMC, ISS/ISE, DSUR, CSR
● Support Regulatory Query Resolutions
Why COD Research Biostatistics?
Lead Biostatistician with 18+ years of experience and worked on 250+ clinical studies
Seasoned advanced SAS Certified Programmer with 11+ years of experience in GCT environment
In-house SAS V 9.4 software for statistical analysis
Handled multiple GCT studies with 20000+ study subjects
Worked in prominent therapeutic areas
Providing support on standalone services via the FSP model
Clinical Design
• Adaptive design
• Sample size calculations
• Randomization plan
Statistical Analysis
• SAP preparation
• SAS programming
• TLF generation
• PK/PD analysis
• CDISC conversion and/or deliverables
(SDTM, ADam, Define)
• Statistical reports development
Contribution
• Protocol development
• Data safety meeting/update
• Clinical study report
Support
• Regulatory query resolutions
Different models
to meet diverse needs
to meet diverse needs
Insights &
Resources
Request For Proposal
We offer an array of niche and full-fledged CRO services, from clinical trial protocol development to post-marketing surveillance. Whatever your need, rope in COD Research experts to breeze through regulatory approvals and get your drug or device on the market soon.
