Elligo Health Research has introduced its SOAR (System of Accelerated Research) technology model, designed to support decentralized and hybrid clinical trials with remote monitoring capabilities. It is intended to increase access to patients, including diverse patient populations that might not typically enjoy access to clinical research as a care option.
According to the company, SOAR helps boost data efficiency by enabling direct data capture from source to submission, as well as permitting fully remote site access.
Rebecca Kush, Elligo Health Research’s chief scientific officer, told Outsourcing-Pharma that the ability to harness decentralized and hybrid trial methods for research has become increasingly important during the COVID-19 crisis.
“The industry was interested in decentralized trials prior to the pandemic, but it seems that the focus was on trying to understand the true meaning of decentralized trials and the relevant regulations. The pandemic forced the issue such that decentralized trials became more of a priority and the demand increased dramatically,” she told us.
What’s more, Kush added, the increased interest in decentralized trial methods has boosted the need for trial monitoring.
“Remote monitoring has now proven its value and clinician demand for it, along with the use of telemedicine, is increasing,” she said.
The SOAR model, Kush explained, collects eSource data in an industry-standard format, enabling real-time visibility into the progress of a study, including potential adverse events. The Elligo clinical control layer (CCL) associated with SOAR focuses on the patient and works to ensure that the investigator and study sponsor can always access the necessary information.
“The ability to make informed decisions based on real-time project visibility results in a safer experience and greater convenience for the patient, the clinician, and the study sponsor (and/or CRO),” Kush told us.
According to Kush, using SOAR has enabled the company to achieve more rapid launches, and increase cost and time efficiency.
“The Elligo team has been able to start up studies six times faster than the industry norm and recruit 150% of expected patients in the required time frame with a 96% retention rate, she said. “Travel costs are significantly reduced, and resources become more efficient.”
Other benefits Kush related include real-time access to source data and metrics, and the opportunity to streamline data flow from source to submission without the need for transcription or mapping.