Biostatistics

Advanced Biostatistics for Leaner and More Efficient Clinical Trials

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Today, less than 10% of new compounds reach the market. The need for advanced biostatistics and efficient clinical development strategies to shorten timelines, reduce costs and risks, and improve the quality of submissions is vital. State-of-the-art statistical methods play a key role in every step of the drug development process.

At IDDI, biostatistics remains an integral part of our services and solutions. Statistics is at the heart of every clinical study—driving study design, protocol development, clinical data collection, analysis and reporting. From study inception to delivery of the Clinical Study Report, our skilled biostatisticians are involved to increase efficiencies at every phase of clinical drug development.
Using optimal clinical trial designs, best-practice randomization methods, regular checks of the randomization balance, data quality assessment, eCRF review, and timely statistical analysis, we deliver clinical trial results that are scientifically accurate, validated and reproducible.

We believe that the most efficient and cost-effective way to conduct and control clinical trials is to make the best possible use of advanced and innovative statistical methodology.

To date, more than 270 pharmaceutical and biotechnology companies, as well as academic cooperative groups and CROs worldwide, have relied on our extensive biostatistics experience, operational excellence, unbiased expertise, independent data quality assessment capabilities and regulatory-compliant procedures to optimize the value of their clinical trials.

760
Biostatistics services & statistical consultancy
208
Independent data monitoring committees (DMCs)
20
FDA/EMA approvals
7
Rescued studies

Complete Range of Services in Advanced Biostatistics

In working with sponsors:

  • We give careful consideration to the objectives of the protocol to determine how they can be statistically supported.
  • We interact with clinicians to determine the possible outcomes and make sure we optimize your clinical trial by developing the right study design.
  • We assess the inherent risk in the study design and ensure robustness and consistency of clinical trial results.

Thanks to advanced methodology, such as Bayesian methods, adaptive designs, modelling and simulations, biomarkers validation, and biomarker-based endpoints, we help you to make better data-driven decisions, mitigate risks, and improve the quality of study submissions.

IDDI Sets Trends in Clinical Research thanks to Biostatistics, the Backbone of the Company

  • With a scientifically-driven culture, IDDI has always been at the forefront of new research methods. The use of advanced methods in trial design is essential to conduct faster, leaner and more reliable clinical studies.
  • Since we devote a portion of our revenues to the deployment of advanced statistical methodology, our philosophy is different from that of purely business-driven companies. 10 years of research have led to the creation of our affiliate, CluePoints, for Central Statistical Monitoring in the context of Risk-Based Monitoring. We have also developed a unique Bayesian methodology to increase the speed of the validation of biomarkers.
  • IDDI works with leading academic institutions, collaborating on new statistical research methods and insights.
  • In-depth experience in a range of therapeutic areas, paired with profound understanding of ICH GCP, regulatory requirements and ADaM analysis datasets, ensures quality throughout all stages of drug development.

Meet your Clinical Trials Objectives with the Support of our Experts in Biostatistics

Our expert biostatisticians offer flexible and innovative solutions for clinical research, and are not afraid to challenge the status quo. With scientific roots and in-depth clinical and regulatory experience, our team understands the scientific issues, anticipating and overcoming potential challenges specific to your clinical trial.

  • Our team of biostatisticians includes 9 PhDs, 1 ScD, 3 MDs and 17 MSCs.
  • Our senior consultants have extensive experience in providing biostatistical advice, from study design and protocol development to study analysis, regulatory submission, and FDA or EMA meeting representation
  • An average of 9.5 years’ experience in biostatistics
    • Over 200 cumulated years’ experience in biostatistics

Unrivaled Experience in Biostatistics

Because figures speak louder than words:

35
FDA/EMA meetings
9
Statistical books
88
Book chapters
3
FDA-quoted papers

600
Scientific publications
650
Scientific conferences