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BOSTON, USA, 12 OCTOBER 2023: Today, global provider of patient-centric data software and services Phesi announces the launch of its new Health Check and Trial Rescue Service. The free of charge service will enable sponsors to submit their protocols to Phesi for a review, offering real-time insights and forecasting within ten working days. The service leverages Phesi’s proven AI-driven Trial Accelerator Platform to assess protocols in terms of patient view, country view, site view and investigator view. It draws on Phesi’s wealth of data from 90,000 dynamically updated sources, including more than 4,000 disease indications and 70.8 million patients, with methods and AI models created and validated over the past fifteen years. Once a protocol is submitted, Phesi will provide insights on key design elements such as inclusion and exclusion criteria.

“The clinical trials industry is facing a chronic challenge,” commented CEO and founder of Phesi, Dr Gen Li. “Once a trial is underway, sponsors are often forced to amend the protocol to better align with the targeted patient population, often with millions of dollars on the line. Further, we know around a fifth of trials designed today will fail and that many “zombie” trials continue to run, mostly caused by inadequate protocol design. Phesi’s new Health Check and Trial Rescue Service addresses these issues by conquering two evergreen challenges: too many protocol amendments and too many failures to complete enrolment as planned. With this service, sponsors can take a proactive, data-driven approach – they won’t need to wait until a study is at risk of failing before they take action.”

Protocol amendments slow down clinical development and are extremely costly. The average phase III protocol experiences 3.3 substantial amendments, with an average cost of $500,000/amendment and cumulatively adding 5.2 months of implementation time. Phesi’s Health Check and Trial Rescue Service uses clinical study data – including control arm data – to inform clinical development planning and decision making, eliminating costly amendments. The service will enable sponsors to make data-informed decisions at every stage of the trial planning and execution process. This includes better understanding enrolment data to predict and maximize patient enrolment, identifying root causes of underperformance, monitoring site activation progress, and assessing CRO run sites.

“We’re launching this new service at the time of year when we know sponsors are considering budgets, reviewing what’s been successful over the past year, and creating their portfolios for 2024,” commented Jonathan Peachey, Chief Operating Officer at Phesi. “The service is designed for everyone – including heads of development, heads of innovation, heads of digital, heads of clinical operations, and heads of portfolios – who would like to gain data-driven insights about the likely outcome of a potential trial, whatever the indication or stage of the trial process. Crucially, the new service will identify any issues in days – rather than months.”

Phesi’s Trial Accelerator Platform is the world’s largest clinical trials database containing real-world data. Phesi can offer a comprehensive and contextualized view of patients, trials, countries, and investigator sites. The patient view enables the construction of Digital Patient Profiles – a digital depiction of patients under study. The trial view is a bridge between operations and the rest of development. Country view and investigator view ensure sponsors select the best sites and investigators for their indication. The Phesi Trial Accelerator has consistently been proven to minimize amendments and shorten cycle times. It has helped Phesi clients to deliver many lifesaving medicines to patients, including Keytruda and donanemab, the most promising drug for Alzheimer's patients.