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.
COMPREHENSIVE BIOSTATISTICS SERVICES FOR THE SUCCESS OF YOUR CLINICAL TRIALS
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!
| DESIGN | Innovative 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 | |
| CONDUCT | 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 | |
| ANALYSIS | Final 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 PUBLICATIONS | 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 | |
| OTHER ANALYSES & SUPPORT | Meta-analysis Validation of surrogate endpoints Exploratory Analyses Biomarker-IVD Validation Support with Regulatory Bodies |
STRONG TEAM OF BIOSTATISTICIANS
- 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.