Cytel

Headquartered in Cambridge, Massachusetts, USA, Cytel Inc. provides clinical trial design services and specialized statistical applications primarily for the biotech and pharmaceutical research markets.

Cytel specializes in adaptive trials – a new type of randomized clinical trial that allows modifications of ongoing trials while aiming to preserve the statistical validity and integrity of the study. Based on either frequentist or Bayesian statistics, adaptive trial designs are increasingly being accepted by government regulatory agencies including the United States Food and Drug Administration (FDA), European Medicines Agency (EMA), and Medicines and Healthcare products Regulatory Agency (MHRA) in early and later stage clinical studies.

As of January 2014, the company claims all 25 top biopharm 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 120 papers in peer-reviewed statistical and medical journals, including The Journal of the American Statistical Association, The Journal of Biopharmaceutical Statistics, Biometrics, Biometrika, Circulation and Statistics in Medicine.

Consultative and Clinical Research Services

 * Adaptive Trial Design
 * Collaborative Research
 * Program and Portfolio Consulting
 * Support for DMCs
 * Randomization Services
 * Biostatistics
 * Statistical Programming
 * Medical Writing
 * Clinical Data Management
 * CDISC Migration
 * Regulatory Submissions
 * Functional Services Outsourcing

Software
East

Clinical trial statistical software for the design, simulation and monitoring of adaptive, group sequential and fixed sample size trials. As of 2013, East 6.2 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, Center for Biologics Evaluation and Research 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.

SiZ

SiZ provides a more modern clinical trial planning approach by combining design, simulation and comparison of trial options and study data analysis within a single interface. SiZ is primarily meant for fixed sample size designs including non-inferiority and equivalence designs.

Compass

Largely the result of a co-development project with a top 3 pharmaceutical company, 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. 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 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 8 was introduced in 2007. 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".

Locations
United States
 * Cambridge, MA (HQ)
 * Waltham, MA
 * Chesterbrook, PA
 * New York, NY
 * San Jose, CA

Europe
 * Geneva, CH
 * Paris, FR

United Kingdom
 * Cambridge, UK

India
 * Pune, IN
 * Hyderabad, IN
 * Bangelore, IN