STUDY DESIGN
Pragmatic, Innovative, and Compliant Clinical Study Design
Well-designed clinical trials are critical to the development and commercial success of new drugs, biologics, biomarkers, and devices.
At IDDI, we base our clinical study design solutions on statistical expertise and research experience, so your product is ready for fast FDA-EMA review.
Proven Expertise in Clinical Study Design
For over 3 decades, IDDI has conducted research in statistics and trial design, made significant contributions to scientific literature, and designed over 550 trials across various therapeutic areas, including oncology (immunotherapy and cell and gene therapy), CNS, ophthalmology, and rare diseases.
Whether you need help with a study that warrants a novel design, requires skilled and computationally complex modeling, or necessitates interaction with various regulatory health authorities like the FDA and EMA, you can rely on our experts every step of the way.
Your Complete Solution for Clinical Trial Design
Your clinical trial has unique design and implementation constraints, from budget and time line to study population.
To help meet these demands, our study design services include:
Conventional, group-sequential, adaptive, and biomarker-based and complex and innovative designs
Frequentist and Bayesian designs
Stopping rules, group-sequential designs, sample-size reestimation
Randomization procedures, sound use of real-world data (RWD) and evidence (RWE)
Non-compartmental analysis (NCA), population pharmacokinetics (PK), modeling
Population, endpoints, outcome assessments
An innovative statistical method for the design and analysis of clinical trials focusing on multiple dimensions, thus enabling sponsors to incorporate all key patient-relevant outcomes in treatment decision (i.e. in primary analysis)
Benefits:
- Increased clinical relevance
- Better leverage your collected data
- Clinical trial designs with multiple endpoints
- Reduced sample size