Study Design

Innovative Clinical Study Design

Our consultants always start with the end in mind, because well-designed clinical trials are critical to successful clinical development of drugs, biomarkers and devices that can reach the market and help patients.

Our strategic input spans all phases of clinical development, therapeutic areas, and statistical methods. Let us know your needs!

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Decades of Expertise in Clinical Study Design within your Reach

WELL DESIGNED AND WELL EXECUTED CLINICAL TRIALS REQUIRE KNOWLEDGE AND EXPERIENCE!

Selection of the patient population
Treatment allocation and randomization (simple, permuted blocks, minimization, dynamic, adaptive, etc)
Sample-size calculation
Scales to measure and standardize treatment benefits or harm
Statistical analysis using state-of-the art and novel methods
Stratification based on biomarkers or other prognostic/predictive features
Choice of efficient and reliable endpoints, as well as validation of surrogate endpoints
Trial simulations
Factorial and cross-over designs for selected situations
Interim analysis
Interaction with regulatory authorities (FDA/EMA) to discuss the study design and defend the study results

Flexible and Innovative Approach to Clinical Study Design

Our consultants 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

BAEYSIAN OUTCOME-ADAPTIVE RANDOMIZATION DESIGNS: A PROMISE NOT WITHOUT PERIL

Learn on the crucial elements of implementing OAR designs and their impact on the operational characteristics
The principles of OAR designs
The key considerations for implementing Bayesian OAR designs and potential challenges ahead
The impact of selected elements of OAR designs on operational characteristics of a clinical trial
The advantages and disadvantages of OAR designs

Study Design

Innovative Clinical Study Design

Decades of Expertise in Clinical Study Design within your Reach

Flexible and Innovative Approach to Clinical Study Design

BAEYSIAN OUTCOME-ADAPTIVE RANDOMIZATION DESIGNS: A PROMISE NOT WITHOUT PERIL

Meet the Consultants Team

Marc Buyse,

ScD

Tomasz

Burzykowski, PhD

Marc Buyse,

ScD

Marc Buyse,

ScD

Marc Buyse,

ScD

Marc Buyse,

ScD

Marc Buyse,

ScD

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