Statistical Consulting Services Based on Years of Experience
Statistical Consulting Services
We provide a huge range of statistical consulting services, which include:
Protocol development and review
Sample size calculations
Randomisation and code break envelope generation using custom-made NCR envelopes for maximum security
CRF advice, design and review
Working alongside EDC systems, and providing consultancy in EDC design
Statistical analysis plan preparation, include table blanks
Executive and full statistical reports
Integrated summary of efficacy and safety
Help desk for immediate consultation
Post-hoc and exploratory analysis
Marketing support analysis
Representative for client at MHRA and FDA meetings
Analysis of all types of data from pre-clinical, clinical and epidemiological trials, following a variety of designs
SAP and programming
Pooling of studies (meta analyses)
Safety and efficacy summaries for regulatory submissions
Data Safety Monitoring Board (DSMB) / Data Monitoring Committee (DMC)
Independent statistician for the DMC and/or DMC analysis
Performing statistical analysis and statistical modelling
General statistical consultancy
Analysis, tables, figures and listings programming
Statistical reporting
Statistical QC
Performing interim analyses and defining stopping rules
Determining how interim analysis results impact sample size
Providing an independent statistician for your unblinded interim analyses
Program validation
Review of tables, figures and listings
Overall summaries of safety and efficacy
Interaction with regulatory authorities
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