ABOUT CYTEL
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 enabled biotech and pharmaceutical companies to navigate uncertainty, prove value and make confident, evidence-based decisions. Our experts deliver industry-leading software, data-driven analytics, real-world evidence and strategic consulting. Headquartered in Waltham, Massachusetts, Cytel has more than 1,400 employees across North America, Europe and Asia. For more information about Cytel, please visit us at www.cytel.com. You also can follow us on LinkedIn and Twitter and like us on Facebook.
FEATURED PRODUCTS
Cytel brings its expertise in adaptive designs to the design and implementation of the industry’s most innovative clinical trials. These highly flexible trials raise peculiar challenges for enrollment, data collection and regulatory submission. Why not have the industry leaders in adaptive design working on your adaptive trials?
Cytel’s dedicated team of professionals is here to help you address an array of challenges when conducting drug development. Whether you face a complex statistical issue or the need for knowledgeable collaborators to handle biometrics and trial implementation, Cytel has skilled professionals available when you need them.
Cytel data scientists apply advanced statistical techniques including predictive modeling of biological processes and drug interactions to unlock the potential of big data. Our team supports biomarker discovery and diagnostic test development based on biomedical signals and images, and real world evidence analysis.
Exposure (and Dose) Response Analyses, including pharmacokinetic and pharmacodynamics analyses, guide critical decisions in drug development. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.
Cytel has a strong track record in providing CDISC solutions and we are a CDISC Registered Solutions Provider. We have converted more than 150 studies as part of NDA submissions, all of which have been accepted by the FDA. The Clinical Data Interchange Standards Consortium (CDISC) devised the SDTM and ADaM models to standardize data structures for submission of raw and analysis data from clinical trials. These standard formats are increasingly expected by regulatory authorities including the FDA.
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.
EnForeSys is a user-friendly decision tool that leverages simulation methods to predict recruitment milestones with high accuracy. Armed with a reliable probability of success, you can rest assured that your trial will reach its targeted enrollment on time and on budget.
We believe that expert statistical input has the power to shape the future of clinical development: de-risking portfolios, accelerating timelines, and increasing the probability of success.
CONTACT INFORMATION
Cytel
1050 Winter Street
Waltham, MA 02451
UNITED STATES
Contact: Rebecca Grimm
FEATURED ARTICLES
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![Orphan Indications and Clinical Trials - Why Rare Diseases Warrant Special Treatment]( "How To Conduct Better Time-To-Event Analysis With Delayed Treatment Effects")
The issue of delayed treatment effects in immuno-oncology was demonstrated during a FDA-Industry sponsored workshop over two years ago. This demonstration made it clear that traditional log-rank tests would need to be replaced as essential assumptions of the test no longer held.
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![technology]( "An Interview With Dr. Albert Kim On Simulation-Guided Design")
In the following interview, Cytel’s Chief Medical Officer Dr. Albert Kim speaks with Dr. Esha Senchaudhuri to discuss many aspects of simulation-guided design – its abilities, its benefits, and so much more.
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![Scientist lab discussion meeting GettyImages-1140779742]( "Adaptive Designs For Early Phase Development: Are The Questions Right?")
In this blog, James Matcham, VP of Strategic Consulting at Cytel reviews essential new innovations in methods related to dose-escalation for single and combination studies.
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![GettyImages-1027139762 trial]( "6 Key Trials For Understanding Adaptive Designs For Clinical Trials")
Suppose you had to choose six clinical trials intended for registration with regulatory agencies to explain to young statisticians what the scope and promise of an adaptive or group sequential design truly is. Which trials, which methods and which strategies would you highlight?
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![doctor meeting clinical iStock-846002754]( "Strategies For Selecting New Indications For A Platform Trial")
Discover how the increasing use of platform trials for the testing of a wide range of therapies raises new questions for trial design optimization and simulation.
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![Patient Care GettyImages-1288871608]( "Platform Trials, Master Protocols, And Challenges In Execution")
How can we build an efficient statistical protocol for a clinical trial, if we do not know the therapies that will be tested nor the populations on whom the testing will occur? In this blog, find out the answer to this question.
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![bio samples in freezer GettyImages-653242048]( "Sufficient Information Threshold For Effective Bayesian Applications")
Discover The Sufficient Information Threshold: a conceptual point that can enable asking questions about the efficiency, ethical quality, and effectiveness of a clinical study.
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![Patient Care GettyImages-1288871608]( "Robust Trial Design Under Treatment And Enrollment Uncertainty")
Learn how new technology can be harnessed to answer an array of questions about early stopping, the pacing of interim analyses, enrollment variability and cost-optimization.
BROCHURES
- Designed For Results
- Solara Software For Optimizing Clinical Trial Design
- East Bayes For Clinical Trial Design
- Solara Software Platform For Clinical Trials
- East® Version 6.5
- Transform Real-World Data Into Real-World Evidence
- Oncology Clinical Development Services
- Independent Statistical Center Function
- From Trial Design To CDISC Submission
- Data Science Brochure
- Quantitative Pharmacology and Pharmacometrics Brochure
- Cytel East Architect Brochure
- EnForeSys Enrollment Forecasting Software Brochure
- Cytel Services Brochure