Strategic Consulting

Advanced clinical research consulting for efficient product development, from dose-finding to confirmatory trials

In today’s complex clinical research landscape, the importance of integrating cutting-edge statistical methods with an in-depth understanding of regulatory constraints has never been more critical! Our mission is to ensure the success of your clinical trial, guiding you seamlessly towards regulatory approval.

At IDDI, we blend decades of experience with unparalleled expertise in biostatistics, approval-optimizing strategies, and regulatory statistics, to to help you confidently navigate the complexities of clinical development.

Is your Clinical Development Strategy READY for Success?


IDDI stands as your steadfast partner, offering regulatory statistics and approval-optimizing strategies that are your roadmap to success. 

  • Streamlined Clinical Development Plans: By harnessing regulatory-best statistical knowledge and pioneering methods, IDDI doesn’t just assist with strategic decisions—we optimize your clinical development journey, significantly reducing time to market with assuredness. 
  • Enhanced Data Quality Assurance: Our profound understanding of regulatory guidance ensures unparalleled data quality, bolstering your trial’s credibility and maximizing regulatory approval chances. 
  • The Backbone of Trial Design: Regulatory statistics is the backbone of trial design in the development of drugs, biomarkers, and devices. IDDI will provide a methodologically sound trial design that will not only meet rigorous regulatory demands for evidence on safety and efficacy but will also enhance the credibility of data submitted for regulatory approval.
  • Expert Consultation for Optimal Outcomes: Our consultants are adept at determining the right sample size, appropriate endpoints, and randomization techniques to solidify your trial’s foundation, maximizing the potential for your drug’s approval.

IDDI’s suite of high-level strategic consulting services ranging from clinical study design and protocol development to regulatory submission including FDA/EMA meeting representation are designed to infuse your clinical development strategy with an unparalleled level of expertise.

  • Trial Design
    • Adjusted level of complexity: Conventional, group-sequential, adaptive, biomarker-based designs, complex and innovative designs.
    • Appropriate statistical framework:  Frequentist and Bayesian designs 
    • Optimized interim decisions: stopping rules, group-sequential designs, sample-size re-estimation.
    • Bias-mitigating methods: Randomization procedures, sound use of real-world data (RWD) and evidence (RWE) 
    • Sample-size calculation and simulations 
    • Input on other study features: population, endpoints, outcome assessments 
    • PK/PD analysis: Non-compartmental analysis (NCA), population pharmacokinetics (PK), modeling. 
  • Clinical Input for Development Plans
    Based on the available preclinical data and clinical results, IDDI helps you with the strategic decisions that are required for further clinical drug development and approval of the product.
  • Regulatory Support
    Our regulatory guidance spans IND and NDA submissions, pediatric exclusivity, rare diseases/orphan drug designation, and IVD and medical device clearances and approvals ensuring your journey to approval is navigated with expertise and confidence. 
  • Input in licensing Deals and Portfolio Management
  • Advanced Biostatistics
  • Validation of surrogate endpoints
  • Seamless and efficient early phase designs
  • Generalized Pairwise Comparisons (GCP)

Partner with IDDI for Confidence 

In choosing IDDI advanced clinical research consulting, you’re not just selecting a service; you’re embracing a partnership defined by confidence. From dose-finding to confirmatory trials, our team is committed to ensuring your path to the success of your product development.

You might be interested in :


  • What is regulatory statistics
  • What is approval-optimization strategies
  • How we help our Sponsors optimize their regulatory strategy with a promising study design
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Learn more on our Flexible and Innovative Approach to Clinical Study Design

Our consultants always start with the end in mind. They always strive to achieve the right balance between scientific rigor and pragmatism, as well as between state-of-the-art methodology and innovation in study design. Our toolkit includes:

  • Statistical, clinical and regulatory acumen
  • Dose-finding, proof-of-concept, confirmatory & pivotal trials
  • Industry, academic & cooperative-group collaboration
  • Frequentist and Bayesian methods
  • Conventional and adaptive designs
  • Interventional, observational, & meta-analytic studies
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Meet the Consultants Team

IDDI’s highly skilled consultants are members of international expert committees. They have published over 950 scientific papers and are invited for lectures across the globe. They have supported more than 350 pharmaceutical and biotechnology companies, as well as academic and cooperative groups, throughout Europe, North America and Asia Pacific.

Marc Buyse, ScD
Founder and Chief Scientific Officer
Everardo Saad, MD
Medical Director
Tomasz Burzykowski, PhD
VP Research
Elisabeth Coart, PhD
Director, Statistical Consulting & Research
Leandro Garcia Barrado, PhD
Research Biostatistician
Vaiva Deltuvaite-Thomas, PhD
Senior Scientist
Vincent Staggs, PhD
Senior Scientist