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Business excellence award 2021

An innovator offering award-winning software solutions for design, analysis, and execution of clinical trials: Cytel

An innovator offering award-winning software solutions for design, analysis, and execution of clinical trials: Cytel

Statistical analysis is the process of collecting, transforming, and organizing data to detect useful information for making a well-informed decision. The statistical analysis gives the business managers real-time data about complex conditions to aid them in making decisions based on facts rather than hunches. The most common usage of statistics is to measure performance, whether it is the performance of an enhanced marketing tactic, a new line of product or simply the performance of the employees. Moreover, it helps businesses predict and navigate through the risks as well as optimize the return on the investment. Globally there are various companies providing statistical software solutions, but Cytel stands out from the rest. Cytel is the largest provider of statistical software and advanced analytics for clinical trial design and execution. For over thirty years, Cytel’s scientific rigor and operational excellence have helped biotech and pharmaceutical companies navigate uncertainty, prove value and unlock the full potential of their data. Founded in 1987 by Cyrus Mehta and Nitin Patel, research scientists at Harvard University and MIT respectively and collaborators at the Dana Farber Cancer Institute, the early mission was to create software that could expedite oncology trials. At the time of founding groundbreaking therapies were slow to market due to the time it took to conduct small sample statistical analysis. After successfully launching StatXact® and LogXact® for small, skewed and sparse data, Cytel pioneered East®, which remains the industry standard for advanced trial design.

With a continued focus on efficient trial design that bends the cost and time curves, Cytel has championed group sequential, adaptive designs, population enrichment trials, seamless trials, and methods of program and portfolio optimization. Cytel’s consultants advise on both large-scale and small sample designs across therapeutic areas including those that are biomarker-driven and employ Bayesian methods and unlock real-world observational data and create opportunities for HEOR and market access. Cytel’s expansive FSP team and project-based services employ world-class biometrics expertise to accelerate high-quality deliverables. A software team continues to produce a package of products that enable these methods to diffuse across the industry, driving up the probability of success. These include East, Compass, StatXact, LogXact, ACES (for DMC Services), and Enforesys for patient recruitment, and from 2020 Solara – a software platform that synthesizes statistics and strategy to help you achieve your development goals.

The Comprehensive Trial Design Solution

Extensive time and energy is often spent designing feasible clinical studies. East's broad range of statistical tools and expert simulations provides an invaluable resource for the rapid construction of trial designs. Illuminating graphs and charts allow for accessible comparison, while a user-friendly interface encourages exploration and experiment. Developed by accomplished study design experts, East creates clinical trials that best address key questions confronted by clinical investigators. East is widely validated in practice and referred to by international regulatory agencies. Powerful simulation tools allow users to compare designs and choose the trial best suited to their study's objectives. Intuitively organized tasks and workflows further enhance productivity. East provides opportunities to optimize the process of selecting superior designs, and ensures access to a range of proven algorithms. Play a more strategic role in your organization: East simplifies and automates study design and simulation, allowing users to redirect time, attention and critical resources to other vital aspects of clinical trial success.

The comprehensive adaptive dose-finding solution

High levels of Phase 3 trial failures often reflect imprecise dose selection during Phase 2. The complexities of designing and implementing early phase dose-finding studies can lead to time-consuming, resource-consuming losses. Traditional Phase 2 development programs often use a sequence of two clinical trials (one trial for proof of concept, followed by another for dose-finding). A single adaptive dose-finding trial can replace these two traditional trials to yield better dose-selection information, plus reduce trial time and size. Play a more strategic role in your organization: Compass simplifies and automates adaptive dose-finding study design and simulation, allowing users to redirect time, attention and critical resources to other vital aspects of clinical trial success. Optimize your trial designs: Rapidly generate multiple adaptive or conventional early phase designs, perform sensitivity analysis to evaluate their robustness to critical assumptions, and use sophisticated tables and graphs to compare and document the operating characteristics of different approaches.

Meet the leader behind the success of Cytel

Cyrus Mehta is a prominent biostatistician, and Fellow of the American Statistical Association. He co-founded Cytel Inc. in 1987 along with Nitin Patel. Their shared vision was to make modern methods in statistics and operations research accessible to clinical researchers, by creating quality software for statistical analyses. Cyrus's efforts helped establish Cytel as an industry leader in exact statistics, as well as in adaptive and group sequential methods. He remains a driving force behind Cytel’s East®, the industry standard software for trial design, simulation and monitoring.

“Success has everything to do with how you design for it. We help you make the right decisions at every step of the development journey so you can get the results you need to succeed.”


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