Elligo’s Decentralized Model for Clinical Research
A Transformative Model
Our System of Accelerated Research (SOAR®) is a transformative model that adheres to all required regulatory processes while accelerating the overall research process, ensuring quality and integrity and focusing on the patient.
“… by two important measures — the number of researchers conducting trials and the number of patients participating in them — our clinical trial capacity is declining.”
– Dr. Robert Giffin and Dr. Janet Woodcock
Key Current Issues
Issue 1: Low physician and patient participation
Issue 2: Clinical research seen as cumbersome
Issue 3: Inadequate bridging of patient care with clinical research
Bridging Research and Healthcare
Elligo developed a transformative model that accelerates the research process.
The patient and physician are at the center, as a dyad
Quality and standards-based data are integrated from the start
Workflow is centered around the patient and healthcare provider
Informed consent is integrated and the process simplified
Learning health cycles are more rapid
Increasing Physician and Patient Involvement
SOAR eliminates the burden of clinical research while keeping physicians and their patients at the center.
Study Leadership and Governance
• Medical and safety assurance
• Regulatory compliance
• Study communications
Recruitment
• Patients and physicians identified and interest assessed in advance
• Registries developed for recruitment and future use
Study Setup and Data Collection
• Standards used from the start
• Patient and site-centric workflow
• eSource data (from study managers, physicians, and patients) using IntElligo
Study Metrics/Management
• Automatically generated from IntElligo
• Dashboard and reports for all stakeholders, including patients
SOAR leverages technology to increase opportunities for research:
Accessing data is more feasible and affordable, paving the way to more appropriate protocols and better qualified patients while enabling improved safety and quality monitoring.
SOAR is fit for complex medical situations and indications requiring meaningful medical oversight:
The focus is on real-world patients in community practices, while protecting the internal validity of the trial through robust procedures and readily available source data to facilitate prompt medical monitoring.
Real-time access to study data facilitates monitoring and safety assurance
Communication
SOAR enables learning health systems:
Research status is available in real time for physicians and sponsors — learnings are summarized and provided to patients and physicians to inform healthcare decisions.
Research findings inform healthcare decisions
Research status available in real time for physicians and sponsors; study result summaries sent periodically to patients and physicians
Site Identification/Physician Engagement
SOAR is patient-centric and respectful of the physician-patient relationship by design:
The patient stays with his/her trusted physician throughout the study, with the aid of trained study managers to offload the administrative burden. Below are results from a survey of physicians who had not previously conducted research:
88%
of physicians were interested in piloting SOAR
82%
of physicians said they would allow Elligo to contact their patients on their behalf to discuss joining a study
88%
of physicians were willing to enter data into a portal for a clinical trial
Patient Recruitment
SOAR is transformative:
Recruitment will be completed in a fraction of the time compared to a similar trial using the legacy model of clinical research. In one case study, lagging enrollment was rectified when Elligo used real-world data to identify qualified patients within three days of IRB approval and prior to the targeted date for enrolling the first patient.
Referred qualified patients 3 days after IRB approval and 5 days prior to sponsor target date for study start
Study Setup
SOAR is powered by a robust technology platform:
The IntElligo® Research Stack platform is built to meet strategic goals, including rapid study setup, centralized data integrity control, streamlined standard data flow from eSource to submission-ready data, treatment of patients in their homes or where they normally go for their healthcare, and processes customized to align with physician workflows.
Study startup is 70-90% faster
using standards from the start
Study Management and Source Documentation
SOAR significantly reduces data transcription and time to access study data and management information:
Data is entered once as standardized eSource data by the Elligo study manager, patient, or physician (as appropriate), compared to today’s process through which data is entered, and/or transcribed 3-5 times. Thus, SOAR improves data quality and provides real-time information to improve medical monitoring and study management.
SOAR is fit for regulated trials, registration trials, and post-marketing trials:
SOAR is designed with all of the principles of ICH E6(R2), 21CFR11, and other relevant regulations undergirding the process and technologies controlling the flow of data.
Ready to see how SOAR® can transform your research?
Elligo Health Research, a healthcare-enabling research organization, uses electronic health records and the trusted patient and physician relationship to ensure all patients have access to clinical research as a care option. Powered by our Goes Direct® approach and novel IntElligo® Research Stack clinical technology, our team provides access to the best healthcare experts, patients, and research technologies. We engage physicians and patients who otherwise would not participate in clinical research and accelerate the development of new pharmaceutical, biotechnology, and medical device and diagnostic products.
