Cytel is a multinational statistical software developer and contract research organization, headquartered in Cambridge, Massachusetts, USA. Cytel provides clinical trial design, implementation services, and statistical products primarily for the biotech and pharmaceutical 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. Based on either frequentist or Bayesian statistics, adaptive trial designs are now widely 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 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 Biostatistics Statistical Programming Medical Writing CDISC Migration 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, 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. Enforesys