Cytel ushers in new era of optimized clinical trial design with launch of Solara™

Waltham, MA, October 6, 2020 — Cytel Inc. has launched Solara™, a collaborative decision-support platform that revolutionizes the identification of optimal clinical trial designs for greater business results for biotech and pharmaceutical companies. The patent-pending platform applies massive cloud computing power to Cytel’s proven statistical design engines to explore an exponentially larger study design space than is possible using traditional methods. The new platform also integrates critical non-statistical considerations and uses interactive visuals to streamline collaboration. Until now, such comprehensive exploration was not possible given compressed clinical development timeframes and currently available trial design software. The platform marks a fundamental shift in the way that development teams approach clinical trial design, enabling the planning of faster, more cost-effective trials. Early usage of Solara has consistently uncovered opportunities to reduce trial duration by 10-20% without compromising cost or probability of success.

Cyrus Mehta, President and Co-founder of Cytel, commented, "By illuminating the statistical design space more thoroughly, we’re enabling teams to better leverage the power of their biostatisticians for more significant business impact. There’s no doubt that confidently selecting the optimal trial design, and expediting the process by which this is done, is a profound step forward for the industry. We’ve already seen fantastic results with Solara, and we look forward to building on its capabilities as it reshapes the way clinical trial design is executed."

Developing and bringing a therapeutic to market has become increasingly competitive, putting clinical development teams under significant pressure to create efficient trials that effectively address patient needs. Frequently, such teams lack sufficient time and resources to fully explore, compare and select the most promising design options to meet both clinical and business goals. They may also lack the communication tools that would allow them to succinctly convey to other stakeholders the benefits and trade-offs of design options in the context of business priorities and constraints. Reaching a consensus can thus be a daunting and lengthy process. Solara is the first tool to enable investigation of the entire relevant study design space to support increased clinical development productivity.

"Current industry approaches to selecting trial designs stifle the true potential of biostatisticians. With the highly pressured timelines that they often work towards, it’s practically impossible to explore more than a small slice of the available designs and test them for sensitivity across different clinical scenarios," said Yannis Jemiai, Chief Scientific Officer at Cytel. "Yet this means teams may be unknowingly settling for suboptimal designs, missing opportunities to better support the broader business goals. Solara enables biostatisticians to review exponentially more designs in a given period of time, freeing up valuable time for more rigorous exploration of options. The result is identification of optimal, efficient studies that can operate with fewer patients, shorter timeframes and/or higher power, while still drawing robust conclusions."

Joshua Schultz, Chief Executive Officer of Cytel, said, "Complementing the ability to more thoroughly map the statistical design space is Solara’s capacity to generate data-driven comparisons of different design options that enable product development teams and governance bodies to rapidly understand the implications of different approaches. Such streamlining of the end-to-end decision process could greatly speed the path to confident decision making."

To find out more about Solara and how it can help support more efficient clinical trial design, please visit: https://www.cytel.com/solara

Waltham, MA, October 6, 2020 — Cytel Inc. has launched Solara™, a collaborative decision-support platform that revolutionizes the identification of optimal clinical trial designs for greater business results for biotech and pharmaceutical companies. The patent-pending platform applies massive cloud computing power to Cytel’s proven statistical design engines to explore an exponentially larger study design space than is possible using traditional methods. The new platform also integrates critical non-statistical considerations and uses interactive visuals to streamline collaboration. Until now, such comprehensive exploration was not possible given compressed clinical development timeframes and currently available trial design software. The platform marks a fundamental shift in the way that development teams approach clinical trial design, enabling the planning of faster, more cost-effective trials. Early usage of Solara has consistently uncovered opportunities to reduce trial duration by 10-20% without compromising cost or probability of success.

Cyrus Mehta, President and Co-founder of Cytel, commented, "By illuminating the statistical design space more thoroughly, we’re enabling teams to better leverage the power of their biostatisticians for more significant business impact. There’s no doubt that confidently selecting the optimal trial design, and expediting the process by which this is done, is a profound step forward for the industry. We’ve already seen fantastic results with Solara, and we look forward to building on its capabilities as it reshapes the way clinical trial design is executed."

Developing and bringing a therapeutic to market has become increasingly competitive, putting clinical development teams under significant pressure to create efficient trials that effectively address patient needs. Frequently, such teams lack sufficient time and resources to fully explore, compare and select the most promising design options to meet both clinical and business goals. They may also lack the communication tools that would allow them to succinctly convey to other stakeholders the benefits and trade-offs of design options in the context of business priorities and constraints. Reaching a consensus can thus be a daunting and lengthy process. Solara is the first tool to enable investigation of the entire relevant study design space to support increased clinical development productivity.

"Current industry approaches to selecting trial designs stifle the true potential of biostatisticians. With the highly pressured timelines that they often work towards, it’s practically impossible to explore more than a small slice of the available designs and test them for sensitivity across different clinical scenarios," said Yannis Jemiai, Chief Scientific Officer at Cytel. "Yet this means teams may be unknowingly settling for suboptimal designs, missing opportunities to better support the broader business goals. Solara enables biostatisticians to review exponentially more designs in a given period of time, freeing up valuable time for more rigorous exploration of options. The result is identification of optimal, efficient studies that can operate with fewer patients, shorter timeframes and/or higher power, while still drawing robust conclusions."

Joshua Schultz, Chief Executive Officer of Cytel, said, "Complementing the ability to more thoroughly map the statistical design space is Solara’s capacity to generate data-driven comparisons of different design options that enable product development teams and governance bodies to rapidly understand the implications of different approaches. Such streamlining of the end-to-end decision process could greatly speed the path to confident decision making."

To find out more about Solara and how it can help support more efficient clinical trial design, please visit: https://www.cytel.com/solara

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.