Cytel - Complex Innovative Clinical Trial Design Service
Every year, sponsors hesitating to use a complex innovative clinical trial design routinely miss opportunities to optimize the speed, savings and probability of success of their clinical trials. Cytel's statistical consultants and data managers work in tandem with sponsors to ensure new medicines move forward with the right study design.
Clinical trials with complex advanced innovative designs use adaptive methods, Bayesian methods and other novel clinical trial design techniques to increase efficiency and reduce costs. Our customer success stories in complex innovative clinical trial design span statistical trial design, regulatory submission, and the execution of advanced innovative trials, with several FDA and EMA approvals.
Cytel have achieved 100% regulatory acceptance of all adaptive clinical trial proposals.
Our statisticians are leading experts in the complex design of adaptive Bayesian design, adaptive promising zone designs, adaptive enrichment clinical trials, basket trials, umbrella trials and more. Their methods have been published in high-ranked academic journals including Nature, NEJM, and CA: A Cancer Journal for Clinicians.
Cytel has a premier team of Bayesian experts who have invented and championed numerous successful early-phase clinical trial design methods including i3+3, MUCE, and more. They have prepared dozens of biotechs to sell their assets to larger pharmaceuticals between Phase 2 and Phase 3.
Cytel has also been a leader in the design of seamless adaptive clinical trials, such as Phase 1a/1b trials and Phase 2/3 trials. These trials repurpose data from the earlier phases of a clinical program to use for analyses of later phases, thus saving critical time and resources.
100% regulatory acceptance of all adaptive clinical trial proposals.
Cytel has pioneered many of the most commonly used adaptive design and Bayesian methods for the statistical design of clinical studies.
Evolving technologies, novel statistical methods for medical trials, increases in computational power and an evolving regulatory framework, all encourage the use of innovative clinical trial design.