Biostatistical Analysis

Turn your complex data into meaningful insights with IDDI

At IDDI, we deliver accurate, reliable, and reproducible results for your clinical trial by using standard and innovative statistical methods recommended by regulatory agencies. 

We complement this with decades of experience interacting and effectively communicating with the FDA and EMA on behalf of our sponsors. 

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A Path to a Successful Clinical Trial: Customized Biostatistical Analysis

No matter how complex your clinical trial is, we tailor our biostatistics services to your needs, ensuring optimal data analysis and interpretation across all therapeutic areas and study phases. 

Our statistical processes support the entire clinical trial life cycle:

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  • Innovative trial design
  • Design and writing of statistical section of the protocol
  • Biostatistician CRF review to ensure the most efficient and correct data collection
  • Creation of randomization lists and randomized kit lists
  • Validation of randomization algorithm
  • Statistical Analysis Plans
  • DMC Charter
  • Monthly randomization checks to ensure groups are well balanced and study drugs are properly allocated
  • Creation of ADaM derived datasets
  • DSUR analyses
  • SAS programming and independent verification of tables, listings, and figures
  • Interim analyses
  • Futility analyses
  • DMC preparation and attendance
  • Final ADaM datasets and associated documentation (define.xml/ADRG)
  • PK analyses (NCA)/PD
  • Final tables, listings, and figures
  • Integrated summaries of safety and of efficacy (ISS, ISE)
  • Statistical appendices in accordance with ICH E3 guideline
  • Statistical review of Clinical Study Report (CSR)
  • Statistical inputs to publications
  • Statistical sections of FDA/EMA submissions
  • Meta-analysis
  • Validation of surrogate endpoints
  • Exploratory analyses
  • Biomarker-IVD validation
  • Support with regulatory bodies

Transform your complex data into clear, actionable insights with our biostatistical analysis services.

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Biostatistical Analysis Resources

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