Cytel launches East On Demand bringing adaptive clinical trial design capabilities to wider biopharma audience
Cytel Inc., the leading global provider of analytical solutions to the life sciences industry, today announced that it will launch East On Demand™ at the annual Joint Statistical Meetings (JSM) 2019 (July 27 – August 1, Denver, Colorado). Offered via the cloud and licensed through subscriptions, East On Demand provides statisticians with more flexible access to East, the industry standard software package for the effective design of adaptive and innovative clinical trials.
Since its introduction in 1995, Cytel’s East platform has provided biotechnology and pharmaceutical companies worldwide with the capability to design and implement the most innovative trial methodologies in line with the latest regulatory guidance. East’s powerful statistical and analytical tools unlock the full potential of the adaptive clinical trial, empowering trial designers to make effective data-driven protocol amendments easily during clinical trial execution. This flexibility helps generate more representative data, reduce sample size and financial investment, and ultimately accelerate the time-to-market for new therapeutics. This approach is immensely valuable to companies with restricted budgets and biotechnology companies operating in therapeutic spaces where patient recruitment challenges are particularly acute.
Now, East On Demand brings access to the full repertoire of East’s clinical design and analysis features to a wider audience, including companies that have less frequent or short-term requirements. Customers that are implementing a smaller number of clinical trials can ensure they are paying only for what they need, with flexible monthly subscriptions and a range of purpose-built toolkits designed for specific clinical trial protocols and therapeutic areas. East On Demand users will also have 24/7 access to the most up-to-date version of East in a fully validated, secure environment in the cloud.
Speaking on the benefits of a flexible, cloud-based clinical trial design platform, Anne Pelz, VP Product Management at Cytel said, “Smaller biotechnology companies face a unique set of challenges when it comes to the clinical development process. They are often working with tight budgets, have limited IT infrastructure for setting up and maintaining software environments, and typically require trial designing capabilities for a much shorter period. They will also benefit most from an optimized adaptive trial design approach because these methodologies allow for the generation of compelling data from small patient groups while significantly reducing overall development costs and risk of trial failure. Cytel has thus ensured that East On Demand offers a holistic solution for the smaller biotech, delivering the full arsenal of adaptive design tools in a way that is optimally accessible for them.”
In conjunction with the launch of East On Demand, Cytel will also be launching StatXact 12 and LogXact 12 at JSM 2019, further broadening the wide selection of tests and procedures for exact inference, power analysis, and regression analysis available in these software packages. The addition of innovative features, like the saddlepoint approximation method and multiple endpoints procedure with gatekeeping, provide new and simple solutions for the most complex computational challenges. Importantly, the version 12 releases support the transition to SAS 9.4, ensuring companies can maintain data integrity and comply with FDA guidances by updating their OS and underlying infrastructure to keep current with security standards and system suitability requirements.