Now more than ever, the clinical development path is full of make-or-break data complexities and analytical challenges. As a pioneer in evidence generation, with deep expertise in advanced analytical solutions, we are uniquely equipped to unlock the value from increasingly complex data. Life Sciences companies count on Cytel to deliver exceptional insight, minimize trial risk and accelerate the development of promising new medicines that improve human life. Cytel provides software solutions for the design and analysis of clinical trials, including industry standards East®, StatXact® and LogXact®, as well as data-focused clinical research services. With operations across North America, Europe, and India, Cytel employs 900 professionals, with strong talent in biostatistics, programming, and data management. For more information about Cytel, visit http://www.cytel.com/.
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.
Cytel
675 Massachusetts Ave # 3
Cambridge, MA 02139
UNITED STATES
Phone: 617-661-2011
Contact: Liz Cole
Across all therapeutic areas, clinical development faces well-documented, critical challenges that impact the pharmaceutical industry's ability to bring new medicines to patients – but in the oncology space, these issues are particularly acute. Read how adaptive trial designs can help address the challenges encountered in anti-cancer clinical development today by saving time, resources and improving the odds of success.
Compared to conventional approaches, a model-based approach to enrollment forecasting provides a more realistic assessment of the possible risks and outcomes for any given scenario, by accounting for the nonlinearity and randomness of real-life enrollment processes. In addition, a model-based approach offers many more advantages other than more realistic expectations.
This article will provide helpful pointers from Paul Terrill, Director of Strategic Consulting at Cytel to ensure smooth communication between statistical and clinical stakeholders.
Data is the most crucial asset in any clinical trial and is used to ultimately drive the decision-making process related to the development candidate. Therefore, for any sponsor, paying close attention to the data management aspects of clinical operations should be paramount. The principles of data management are simple and well-founded. However, the application of these principles needs careful consideration, depending on various scenarios and the size of the organization. When implementing data management for your trial, it is critical to plan ahead and fully understand all the steps and activities involved.
Data managers need to equip themselves with skills to make sense of an ever-expanding world, while maintaining adherence to core principles of safety and efficacy.
In this blog, Paul Fardy, Executive Director of Data Management at Cytel shares his thoughts on how the data manager role has evolved.
Patti Arsenault, Cytel's Global Head of Data Management, shares her thoughts on the three core elements important for the success from the data management standpoint - effective timeline management, thoughtful database design, and a proactive approach to data cleaning.
Trial sponsors must carefully plan their data consolidation and analysis strategies not only in preparation for CDISC-compliant submissions, but to respond to market influences and evolving clinical partnership models.
Results from a recent Deloitte survey explored if data science could be about to revolutionize the regulatory approval of new drugs.
Highlights from Adam Hamm, Director Biostatistics at Cytel, presentation on best practices and operational considerations for adaptive designs and interim analyses.
In the new era of big and complex data, conventional methods of solving search problems are sometimes ineffective.Genetic algorithms provide a highly effective solution to many such problems, and therefore their popularity and adoption are on the rise.
An important trend in clinical development involves integrating strategic pharmacometric analysis with program-level decision making to make the most use of available data. This article highlights five reasons why you should consider utilizing model-based meta-analyses (MBMAs) for your program or portfolio development.
NCAs are an integral part of establishing an early phase audit trail, it is important to use NCA software that streamlines a detailed and complex workflow.
Many drugs in the IO arena do not follow well understood traditions so the standard statistical approaches to evaluating safety and efficacy may not always be optimal or efficient. As it turns out, as is often the case with methodological research, that alternative methods are available, have been for a long time.
AstraZeneca needed a software tool that could create standardized outputs to streamline communication, save time, and extend the framework with additional features.
Client turns to this CRO when they needed a team experienced with the full range of IDMC activities to provide a seamless solution.
CRO’s strategic consulting group helps clients create and apply innovative trial designs within exploratory and confirmatory oncology development.
Understand the concept and benefits of adaptive trials and if they should be a consideration for your company.
