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Biostatistics and Statistical Programming offers you Accurate Data Analysis complying with Regulatory Requirements
Our experienced Statisticians and Statistical Programmers help our customers in analysis of clinical trials of all types including parallel, crossover, multi-phase and PK/PD studies. Our statisticians and programmers are committed to follow SOPs and ICH guidelines. We are flexible in producing reports in sponsor-defined templates or our standard templates. Our processes and procedures are well documented to help produce high quality outputs on time.
Our biostats statistical programming services include:
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Statistical inputs to protocol development
CDISC SDTM mapping and conversion
Pooled/Integrated Analysis (ISS and ISE)
Sample size calculation
Generation of Analysis Data in ADaM data model
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Randomization schemes
TLF programming for analysis and reporting of clinical trial data
Analysis for Real World Evidence
Independent Statisticians
Interim Analysis for DMCs and DSMBs
Statistical Analysis Plan
PK/PD Analysis
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