Cytel is a multinational

statistical Statistics (from German language, German: ', "description of a State (polity), state, a country") is the discipline that concerns the collection, organization, analysis, interpretation, and presentation of data. In applying statistics to a s ...

software Software consists of computer programs that instruct the Execution (computing), execution of a computer. Software also includes design documents and specifications. The history of software is closely tied to the development of digital comput ...

developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides

clinical trial Clinical trials are prospective biomedical or behavioral research studies on human subject research, human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel v ...

design and implementation services, and statistical software products primarily for the biotech and

pharmaceutical Medication (also called medicament, medicine, pharmaceutical drug, medicinal product, medicinal drug or simply drug) is a drug used to diagnose, cure, treat, or prevent disease. Drug therapy ( pharmacotherapy) is an important part of the ...

development markets. Cytel specializes in adaptive trials – a type of randomized clinical trial that allows modifications of ongoing trials while aiming to preserve the statistical validity and integrity of the study.Cytel - Pharmacompare - Your Source for Preclinical, Clinical and Pharmaceutical Products and Services
/ref> Based on either frequentist or

Bayesian statistics Bayesian statistics ( or ) is a theory in the field of statistics based on the Bayesian interpretation of probability, where probability expresses a ''degree of belief'' in an event. The degree of belief may be based on prior knowledge about ...

, adaptive trial designs are now widely accepted by government regulatory agencies including the United States

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA),

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

(EMA), and

Medicines and Healthcare products Regulatory Agency The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department of Health and Social Care in the United Kingdom which is responsible for ensuring that medicines and medical devices work and are accepta ...

(MHRA) in early and later stage clinical studies. As of January 2024, Cytel asserts that its software products and services are used by 30 large biopharmaceutical companies. With a presence spanning North America, Europe, and Asia, the company has a workforce exceeding 2,000 employees.

Background

Company founders Cyrus Mehta, Ph.D. and Nitin Patel, Ph.D. are among the pioneering statisticians credited for developing the underlying statistical methods behind so-called “flexible” designs: group sequential and adaptive trials. As of 2024, Cytel statisticians have collectively published over 140 papers in peer-reviewed statistical and medical journals.

Cytel consulting

Cytel's consulting arm focuses on optimizing approaches for biopharma clinical research development objectives. Functional elements their Strategic Consulting team claims to provide include: * Adaptive Trial Design and Implementation * Collaborative Research Projects * Program and Portfolio Optimization * Regulatory Interactions * Multiplicity * Missing Data * DMC Membership * Independent Statistical Committee * Advanced Real-world Analytics * Health Economics and Outcomes Research

Clinical research services

Cytel's clinical research services arm focuses on improving the probability of success for biopharma clinical research development efforts. Functional elements their clinical research services team claim to provide include: * Support for DMCs * Randomization Services *

Clinical Data Management Clinical data management (CDM) is a critical process in clinical research, which leads to generation of high-quality, reliable, and statistically sound data from clinical trials. Clinical data management ensures collection, integration and availa ...

Biostatistics Biostatistics (also known as biometry) is a branch of statistics that applies statistical methods to a wide range of topics in biology. It encompasses the design of biological experiments, the collection and analysis of data from those experimen ...

* Statistical Programming * Medical Writing * CDISC Migration * Regulatory Submissions * Quantitative Pharmacology * Pharmacometrics * Data Science * Complex and Innovative Designs

Software products

East Horizon In 2021, Cytel released Solara, the industry's first-to-market clinical trial strategy platform for simulation-guided clinical study design and selection. In 2024, Cytel expanded the capabilities of Solara by incorporating statistical tests from its Windows-based software East and added the ability to extend its native tests by pulling in custom R functions, and rebranded the product East Horizon. East East clinical trial statistical software supports the design, simulation and monitoring of adaptive, group sequential and fixed sample size trials. As of 2024, East 6.5 is in use at over 140 pharmaceutical and biotechnology companies, research centers and regulatory agencies including the FDA's

Center for Drug Evaluation and Research The Center for Drug Evaluation and Research (CDER, pronounced "see'-der") is a division of the Food and Drug Administration (United States), U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmet ...

Center for Biologics Evaluation and Research The Center for Biologics Evaluation and Research (CBER) is one of six main centers for the U.S. Food and Drug Administration (FDA), which is a part of the U.S. Department of Health and Human Services. The current Director of CBER is Vinay Pras ...

and Center for Devices and Radiological Health divisions. First introduced by the Cytel Software Corporation in 1995 as “East DOS”, the name is derived from the benefit of 'early stopping' a trial due to futility: a failure of the tested treatment to demonstrate significant improvement over an existing treatment and/or

placebo A placebo ( ) can be roughly defined as a sham medical treatment. Common placebos include inert tablets (like sugar pills), inert injections (like saline), sham surgery, and other procedures. Placebos are used in randomized clinical trials ...

. Enforesys Introduced by Cytel in 2015, Enforesys is a

feasibility study A feasibility study is an assessment of the practicality of a project or system. A feasibility study aims to objectively and rationally uncover the strengths and weaknesses of an existing business or proposed venture, opportunities and threats pr ...

decision-making tool for predicting recruitment milestones. Enforesys uses historical study site-level data and simulation models to calculate a numerical probability of success for study enrollment strategies. Compass Compass is used by biostatisticians and clinicians to plan and design earlier stage adaptive clinical trials (traditionally known as phase 1 human tolerance and phase 2 dose-selection studies). Compass was the first commercially offered adaptive trial composition software with both frequentist and

Bayesian methods Bayesian inference ( or ) is a method of statistical inference in which Bayes' theorem is used to calculate a probability of a hypothesis, given prior evidence, and update it as more information becomes available. Fundamentally, Bayesian inferen ...

. Other key capabilities include R code integration, trial simulation compute engines, plus various tables, charts and graphs to visualize and communicate trial design attributes. StatXact Statistical software based on the exact branch of statistics used for small-sample categorical and nonparametric data problem-solving. Used by statisticians and researchers in all fields of study, StatXact now has 150 different non-parametric statistical tests and procedures. Initially offered in 1989 as StatXact DOS, StatXact 12 was released in 2021. The StatXact PROCs variant integrates with the popular SAS statistical software. LogXact A

logistic regression In statistics, a logistic model (or logit model) is a statistical model that models the logit, log-odds of an event as a linear function (calculus), linear combination of one or more independent variables. In regression analysis, logistic regres ...

predictive modeling software package suited particularly to cases involving small samples and/or missing data. Logistic regression is used extensively in the medical and social sciences as well as marketing applications to predict subject behavior. First made available in 1996 under the name LogXact Turbo, LogXact was introduced in 2007 and is currently in its eleventh release. The LogXact PROCs variant integrates with the popular SAS statistical software. ACES Cytel's web-based Access Controlled Execution System. ACES simplifies compliance with the related FDA guidance and EMA guidelines by a secure means of communicating a clinical trial's interim analysis results and recommendations between the Data Monitoring Committee (DMC/DSMB), Independent Statistical Center and clinical team members. The validated system automatically creates an audit trial, allowing regulators to readily determine "who saw what and when". OKGO OKGO is the first commercially available software to support the implementation of a quantitative go/no-go decision-making framework in clinical trials.

Locations

United States * Cambridge, Massachusetts (HQ) * Seattle, WA (Axio Research) Canada * Toronto, ON * Vancouver, BC Europe * Geneva, CH * Paris, FR * Barcelona, ES * Basel, CH * London, UK * Rotterdam, NL Asia * Shanghai, CN * Singapore, SG India *

Pune Pune ( ; , ISO 15919, ISO: ), previously spelled in English as Poona (List of renamed Indian cities and states#Maharashtra, the official name until 1978), is a city in the state of Maharashtra in the Deccan Plateau, Deccan plateau in Western ...

Hyderabad Hyderabad is the capital and largest city of the Indian state of Telangana. It occupies on the Deccan Plateau along the banks of the Musi River (India), Musi River, in the northern part of Southern India. With an average altitude of , much ...

Ahmedabad Ahmedabad ( ), also spelled Amdavad (), is the most populous city in the Indian state of Gujarat. It is the administrative headquarters of the Ahmedabad district and the seat of the Gujarat High Court. Ahmedabad's population of 5,570,585 ...

References