Biostatistical Analysis

Comprehensive Biostatistics services for the success of your Clinical Trial

Innovative statistical methods to provide results that are accurate, reliable, and reproducible

Biostatistical analysis: Improving Reliability and Consistency of Your Clinical Trial Results

When providing biostatistical analysis, IDDI’s statisticians implement both standard and innovative statistical methods to provide results that are accurate, reliable, and reproducible, using techniques that are recommended by the regulatory agencies.

Our expert biostatisticians offer flexible and innovative solutions and are not afraid to challenge the status quo. As a biostatistics CRO with scientific roots and in-depth clinical and regulatory experience, our team understands the scientific issues, anticipates, and overcomes potential challenges specific to your clinical trial.


No matter the complexity of your clinical trial, we will tailor a solution to your clinical data analysis needs. We use innovative study designs and advanced biostatistical methodology to support clinical trials in any phase in any therapeutic area.

Discover IDDI’s statistical processes to support the clinical trial life cycle: Hover your mouse!

Biostatistical_Analyses_graphic Conduct Set-up Report & Publication Analysis Other analyses Design
DESIGNInnovative trial design
Design and writing of statistical section of the protocol
SET UP CRF Review by Biostatistician to ensure the most efficient and correct data collection
Creation of randomization lists and randomized kit lists
Validation of randomization algorithm
CONDUCTStatistical 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
ANALYSISFinal ADaM datasets and associated documentation (define.xml/ADRG)
PK Analyses (NCA)
Final tables, listings and figures
Integrated summaries of safety and of efficacy (ISS, ISE)
REPORT AND PUBLICATIONSStatistical appendices in accordance with ICH E3 guideline
Statistical review of Clinical Study Report (CSR)
Statistical inputs to publications
Statistical sections of FDA/EMA submissions
Validation of surrogate endpoints
Exploratory Analyses
Biomarker-IVD Validation
Support with Regulatory Bodies
Submit RFI
  • Our strong team of senior biostatisticians and statistical SAS programmers produces high-quality, reproducible analysis and reporting of clinical trial results across all therapeutic areas.
  • The biostatistics team, which accounts for a third of IDDI employees, is committed to providing the very latest statistical thinking. Therefore, we stay abreast of the latest statistical methods and related regulatory preferences.
  • Our statisticians are experienced in interacting with the FDA/EMA and other regulatory agencies and pride themselves of effectively communicating on behalf of our Sponsors.
  • All clinical studies are performed in compliance with FDA and CDISC requirements.
  • Our SDTM/ADaM experts have the ability and experience in developing eCRFs to CDISC/CDASH standards and delivering data in STDM and ADaM standards.
  • The department also has extensive experience with Data Safety Monitoring Boards (DSMB), including charter development, safety and efficacy analyses, and conduct and documentation of DSMB meetings.
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