Clinical Study Design

Innovative Clinical Study Design

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Bringing Decades of Expertise in Clinical Study Design and Strategic Input for Your Successful Clinical Drug Development

Well-designed and well-executed clinical trials are critical to successful clinical development of drugs, biomarkers, and devices. You need a partner who will carefully help you plan the course of your clinical trial, proactively improve predictability, reduce risks, and help you reach Go/No-Go decisions faster. IDDI expert biostatisticians will partner with you to provide the optimal clinical study design, looking for efficacy signals to prioritize your pipeline and achieve better outcomes for the resources spent.

Our expert consultants have recognized expertise in clinical research, including biostatistics, clinical medicine, and regulatory science. This multi-disciplinary environment will greatly add value to your capabilities and better enable you to design and launch a successful clinical study. This includes developing the synopsis and the full protocol document, calculating the sample size for conventional, group-sequential or adaptive designs (including Bayesian designs), running trial simulations, and proposing innovative solutions to expedite and optimize chances of success of your clinical trial.

At IDDI, we have proven clinical trial design experience:

200
Protocols to date

Advanced Biostatistical Methods for Clinical Study Design and Analysis

Trial Design Services Include: 

  • Selection of the patient population;
  • Stratification based on biomarkers or other prognostic/predictive features;
  • Treatment allocation methods (balanced, unbalanced, adaptive, minimization, permuted blocks, etc);
  • Choice of efficient and reliable endpoints, as well as validation of surrogate endpoints;
  • Sample size calculation;
  • Trial simulations;
  • Adaptive trial set-up;
  • Scales to measure and standardize treatment benefits or harm;
  • Factorial and cross-over designs for selected situations;
  • Statistical analysis using of state-of-the art and novel methods;
  • Interim analysis
  • Deep experience in assisting clients in dealing with regulatory authorities, including the FDA and EMA, to discuss the study design or to defend the study results.

Flexible Approach to Clinical Study Design 

  • Our experts will tailor trial design according to the appropriate clinical phase and Clinical study designobjectives.

    • Phase I: Classical modified Fibonacci, continual reassessment method, other adaptive and model-based dose-escalation methods to improve efficiency
    • Phase II: Single-arm, randomized, adaptive, dose-finding, multi-stage, cross-over, biomarker-stratified, seamless phase II/III, basket and umbrella trials
    • Phase III: Superiority, non-inferiority, cross-over, group-sequential, adaptive, biomarker-stratified, factorial trials
    • Phase IV: Large, simple trials for “real-world” settings and comparative effectiveness research 
  • Strategic clinical drug development consulting services to help our clients face the challenges of clinical drug development: 
    • Input in the context of licensing deals and portfolio management
    • Guidance for IND and NDA submissions, biomarker approvals, paediatric exclusivity, and orphan drug designation, among others

IDDI Consultant Team: 

MARC BUYSE, ScDTOMASZ BURZYKOWSKI, PhDEVERARDO SAAD, MDSTEFAN MICHIELS, PhD
(trial design, endpoints, biomarkers)(surrogate endpoints, adaptive and Bayesian designs)(trial design, endpoints, clinical issues)(trial design, biomarkers)
ELS COART, PhDKOENRAAD D’HOLLANDER, MD, MScAGNES WESTELINCK, PharmD
(development and validation of biomarkers and IVDs)(Bayesian methods, adaptive designs)(regulatory affairs)