Strategic Consulting

Navigating the Path to Regulatory Approval

Leverage IDDI Statistical Knowledge of the Regulatory Approval Process to Optimize your Clinical Development Strategy

In the ever-evolving landscape of drug development, approval-optimization strategies play a pivotal role in ensuring the success of your clinical trials and eventual approval by regulatory authorities.

We leverage the power of regulatory statistics to support our Sponsors in developing a robust statistical design that will maximize the chances of approval for your promising drug.

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Regulatory Statistics and Approval-optimization Strategies from Dose findings to Confirmatory Trials

APPROVAL-OPTIMIZATION STRATEGIES

  • Streamlined Clinical Development Paths.
    By implementing regulatory-compliant statistical methodologies and innovative strategies, IDDI helps you with the strategic decisons and optimizes your clinical development path and reduces time to market.
  • Data Quality Assurance
    Robust statistical knowledge of regulatory guidances and process ensure data quality and increases the chances of regulatory approval.

REGULATORY STATISTICS

  • Regulatory statistics is the backbone of trial design for the development of drugs, biomarkers, and devices. Regulatory bodies demand rigorous evidence to ensure the safety and efficacy of new products.
  • A methodologically sound trial design not only meets these stringent requirements but also enhances the credibility of data submitted for regulatory approval. IDDI’s expert consultants team helps you determine the right sample size, appropriate endpoints, and effective randomization techniques.

Comprehensive Services to Help with Your Clinical Development Strategy

IDDI’s expert consultants provide high-level strategic consulting services ranging from clinical trial design and protocol development to regulatory submission including FDA/EMA meeting representation. IDDI offers the medical experience, biostatistical acumen and regulatory knowledge that are required to design and launch clinical trials that ask the right questions regardless of the trial phase.

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

Regulatory guidance for IND and NDA submissions, biomarker approvals, pediatric exclusivity, and rare diseases/orphan drug designation

INPUT IN LICENSING DEALS & PORTFOLIO MANAGEMENT

ADVANCED BIOSTATISTICS

Validaton of surrogate endpoints, Generalized Pairwise Comparisons (GPC), …

TRIAL DESIGN

  • Adapted level of complexity (conventional, adaptive, biomarker-based design, complex & innovative designs)
    • Appropriate statistical framework (frequentist, Bayesian)
    • Optimized interim decisions
    • Bias-mitigating methods (random allocation, sound use of real-world data (RWD) and evidence (RWE)
    • Sample-size calculation and simulations
    • Input on study population, endpoints, assessments
    • PK/PD analysis​: Non-compartemental analysis (NCA), Population pharmacokinetics (PK), Modeling.
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LEARN MORE ON APPROVAL-REGULATORY STRATEGIES AND REGULATORY STATISTICS

  • 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