The complexity of clinical research and development has increased exponentially, putting a strain on outdated systems used to support the business processes required to conduct a clinical trial. To alleviate these complexities, Oracle Health Sciences recently launched Clinical One Randomization and Supplies Management Cloud Service (ORS), which reduces the time required for study set up from nearly two months to just a few days. Since its introduction, more than one thousand patients have already been screened, and 78 percent of them randomized, through the cloud service.

“At Oyster Point Pharma, we are developing a revolutionary new treatment for dry eye disease, and with the Oracle Randomization and Supplies Management Cloud Service, we have been able to significantly reduce our clinical trial setup time. In 2018 alone, as a start-up company, we initiated and completed 3 separate phase 2b trials using the Oracle Health Sciences cloud service,” said Jeffrey Nau, president and CEO, Oyster Point Pharma.

A recent survey of executives from pharma and contract research organizations highlighted the top challenges in Randomization and Trial Supplies Management (RTSM) in clinical trials. For more than 70 percent of respondents, slowness to build, test and deploy new trials; integration with other platforms and lack of flexibility; and inability to support study changes were paramount.

“Our mission is to support our pharmaceutical and CRO customers in bringing drugs to market faster, and more efficiently,” said Steve Rosenberg, general manager, Oracle Health Sciences. “We continue to drive new innovations to simplify the building, launching, and operation of clinical trials. ORS represents a major step in that regard by greatly reducing the build time. Each day saved during a clinical trial is one day closer to bringing a new therapy to market for patients waiting in need.”

A breakthrough in conducting trials, Oracle Clinical One Randomization and Supplies Management enables pharmaceutical companies to gain new levels of:

• Speed and Flexibility – self-service point and click trial design and set up in several days whether through a CRO or clinical R&D staff
• Simplicity and Control – ability to make mid-study protocol changes with the click of a mouse
• Integration and Efficiency – ORS is easily integrated with Oracle’s existing electronic data capture (EDC) solution, InForm, and seamlessly integrates with other, existing EDC solutions on the market
• Data Unification – because ORS is part of the Clinical One eClinical platform, data can be shared across people, processes and systems throughout the entire lifecycle of a trial