Oracle Health Sciences, a a division of Oracle specializing in cloud-based life-sciences technology, and contract research organization (CRO) FHI Clinical, are working together to create solutions that can boost clinical trial efficiency and help sponsors get therapies to market more rapidly.
Rob King, chief operating officer of FHI Clinical, told Outsourcing-Pharma that the company connected with Oracle to help overcome a number of challenges and design in particular advantages.
“We had the unique opportunity to start with a blank slate and design the ideal data system environment; we knew that we wanted systems that were easy to use, allowed for seamless sharing of data and reporting,” King told us. “We wanted the average user to be able to set-up, access and generate the data they need without the assistance of experienced programmer—particularly, we wanted systems that could be used in resource limited settings that were not only easy to use but were priced at a lower cost point.”
As COVID-19, Ebola and other pandemics have demonstrated, response to outbreaks require coordinated, intelligent approaches in order to come up with effective therapies. However, especially in regions that have little or no existing research capacity, researchers can find it difficult to start studies and manage through the entire lifecycle, thanks to lack of regulatory guidance, sufficient infrastructure, qualified staff, established sites, laboratory facilities and other resources.
Such environments, King pointed, create formidable obstacles that trial teams must overcome.
“Historically, global trials conducted in resource limited settings have had to use paper or less robust data management options due to lack of funding; many people do not realize that significant advances in infectious disease vaccination and treatment were achieved with little technology support,” he said. “While this is inspiring, it does beg the question what could have been achieved if the latest technology had been available.”
FHI Clinical selected Oracle’s Clinical One platform to help meet such challenges.
“Clinical One appealed to us mainly because it was the system we would have built ourselves; it is cloud based, modular in use, requires no experienced programmer support, has a single central database and a price point that would allow us to use it in resource limited settings,” King said. “Knowing that Clinical One includes the features and capabilities of already recognized best in class systems such as Inform, Argus and Siebel gave us confidence that we were procuring some of the best solutions in our industry.”
Oracle’s Clinical One cloud platform is designed to support all the core capabilities required for effective study management throughout the entire drug development lifecycle. Ted FitzGerald, FHI Clinical president and CEO, said the company’s experience in crisis-response settings has shown its leaders the need to develop a systematic approach to rapid study start-up that can be applied across different locales and therapeutic areas.
“Integrating the Oracle Clinical One platform into our approach allows us to bring best-in-class clinical software to markets and segments previously neglected, enabling us to meet compressed trial timelines with the highest quality data possible. As trial needs evolve and change, we are equipping our clients both large and small to be prepared for those changes with the ease and flexibility of Clinical One,” he said.
FHI Clinical reportedly has adopted Clinical One for randomization, supply management, and data collection. The company also uses Oracle Argus Safety for safety case management; Oracle Clinical Trial Management System (CTMS) Cloud Service to manage the entire research portfolio, including study status and financial reporting; and Oracle ClearTrial Cloud Service to help budget, plan and bid on projects.