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.
Successful studies begin with the right design. East is the industry standard for designing adequate and well-controlled clinical trials as per FDA and EMA guidance. Since its introduction in 1994, East has reliably and continuously enabled drug and medical device trial sponsors of all sizes to optimize their trial planning and monitoring efforts.
East® version 6.4 continues Cytel’s 20+ years tradition of reliable innovation in the design, monitoring and simulation of clinical trials.
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.
Today, more than half of clinical studies take longer than expected to achieve their enrollment targets, often leading to discontinued trials, and expensive failures. EnForeSys is a user-friendly decision tool that leverages cutting-edge simulation methods to predict recruitment milestones with high accuracy. Armed with a reliable probability of success, you can rest assured that your trial will achieve its target enrollment on time and on budget.
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.
Cytel is committed to improving the quality, analysis and interpretation of data for clinical development. Founded by world-renowned biostatisticians and Fellows of the American Statistical Association, Cytel maintains a tradition of leadership in statistical innovation. Our team is dedicated to improving the probability of clinical trial success and helping to deliver new medicines to the patients who need them.
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.
When considering clinical trial disclosure solutions, it is important to understand the potential partner’s practical experience and how their solution fits your compliance needs today and in the future.
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