Study Design
Innovative Clinical Study Design
START WITH THE RIGHT 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!
Talk to an expertDecades 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
Meet the Consultants Team
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| Marc Buyse, ScD | Tomasz Burzykowski, PhD | Everardo Saad, MD | Els Coart, PhD | Leandro Garcia Barrado, PhD | Vaiva Deltuvaite-Thomas, PhD | Vincent, Staggs, PhD |
AD-HOC CONSULTANTS
- Dr Stephan Michiels, PhD Biostatistical Expert
VelosBio worked closely with Marc Buyse and Elisabeth Coart. They were both very insightful, knowledgeable, innovative in their approach, communicative, and rapidly responsive with their development and review of documents. The support they provided was very valuable and our interactions with them were truly a pleasure. I would be more than happy to recommend IDDI to others.
Langdon L Miller, MD, Chief Medical Officer, VelosBio Inc.
WATCH WEBINAR
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