Cytel is a multinational statistical software developer and

contract research organization In the life sciences, a contract research organization (CRO) is a company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis. A CRO may provid ...

, headquartered in Cambridge, Massachusetts, USA. Cytel provides

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

design, implementation services, and statistical products primarily for the

biotech Biotechnology is the integration of natural sciences and engineering sciences in order to achieve the application of organisms, cells, parts thereof and molecular analogues for products and services. The term ''biotechnology'' was first used b ...

and

pharmaceutical A medication (also called medicament, medicine, pharmaceutical drug, 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 medical field and re ...

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 Frequentist inference is a type of statistical inference based in frequentist probability, which treats “probability” in equivalent terms to “frequency” and draws conclusions from sample-data by means of emphasizing the frequency or pr ...

Bayesian statistics Bayesian statistics 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 the event, ...

, 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 respon ...

(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 medicinal products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products or Euro ...

(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 acceptably ...

(MHRA) in early and later stage clinical studies. As of January 2014, the company claims 25 large biopharmaceutical companies as users of its software to design, simulate, and analyze trials.

Background

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

Cytel Consulting

Cytel's Consulting arm focuses on optimizing the approach 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 availabi ...

Biostatistics Biostatistics (also known as biometry) are the development and application of 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 experime ...

* Statistical Programming *

Medical Writing A medical writer, also referred to as medical communicator, is a person who applies the principles of clinical research in developing clinical trial documents that effectively and clearly describe research results, product use, and other medical i ...

CDISC Migration The Clinical Data Interchange Standards Consortium (CDISC) is a standards developing organization (SDO) dealing with medical research data linked with healthcare, to "enable information system interoperability to improve medical research and rela ...

* Regulatory Submissions * Quantitative Pharmacology * Pharmacometrics * Data Science * Complex and Innovative Designs

Software

East East Clinical trial statistical software for the design, simulation and monitoring of adaptive, group sequential and fixed sample size trials. As of 2019, 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 U.S. Food and Drug Administration (FDA) that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. Some biological products are also leg ...

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

and

Center for Devices and Radiological Health The Center for Devices and Radiological Health (CDRH) is the branch of the United States Food and Drug Administration (FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safe ...

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 ( ) is a substance or treatment which is designed to have no therapeutic value. Common placebos include inert tablets (like sugar pills), inert injections (like Saline (medicine), saline), sham surgery, and other procedures. In general ...

. 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. Enforsys utilizes 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 is the first commercially offered adaptive trial composition software with both frequentist and

Bayesian methods Bayesian inference is a method of statistical inference in which Bayes' theorem is used to update the probability for a hypothesis as more evidence or information becomes available. Bayesian inference is an important technique in statistics, and e ...

. 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. Utilized by statisticians and researchers in all fields of study, the StatXact software now has 150 different non-parametric statistical tests and procedures. Initially offered in 1989 as StatXact DOS, StatXact 8 was released in 2007. The StatXact PROCs variant integrates with the popular SAS statistical software. LogXact A

logistic regression In statistics, the logistic model (or logit model) is a statistical model that models the probability of an event taking place by having the log-odds for the event be a linear function (calculus), linear combination of one or more independent var ...

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 In clinical trials and other scientific studies, an interim analysis is an analysis of data that is conducted before data collection has been completed. Clinical trials are unusual in that enrollment of subjects is a continual process staggered in ...

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". SiZ In 2012, SiZ as a stand-alone product was deprecated, and its feature set was consolidated into the company's East product. OK GO OK GO 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) * Waltham, MA * King of Prussia, PA * San Jose, CA 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 (; ; also known as Poona, (List of renamed Indian cities and states#Maharashtra, the official name from 1818 until 1978) is one of the most important industrial and educational hubs of India, with an estimated population of 7.4 million ...

Hyderabad Hyderabad ( ; , ) is the capital and largest city of the Indian state of Telangana and the ''de jure'' capital of Andhra Pradesh. It occupies on the Deccan Plateau along the banks of the Musi River (India), Musi River, in the northern part ...

Bengaluru Bangalore (), officially Bengaluru (), is the capital and largest city of the Indian state of Karnataka. It has a population of more than and a metropolitan population of around , making it the third most populous city and fifth most ...

Mumbai Mumbai (, ; also known as Bombay — the official name until 1995) is the capital city of the Indian state of Maharashtra and the ''de facto'' financial centre of India. According to the United Nations, as of 2018, Mumbai is the second- ...

Ahmedabad Ahmedabad ( ; Gujarati: 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 (per t ...

References