ObvioHealth has a list of preferred sites and providers that may be invited to participate in a clinical trial. To be added to the preferred provider/site directory, the site, and the provider must undergo a site/provider qualification assessment. To be selected for a trial, the site/provider will undergo a site feasibility assessment. Our new partnership with a leading healthcare and diagnostic software solutions provider will also enable us to enlist HCPs within their networks to participate in distributed trials that are integrated directly into physician workflows.
Yes. Our strategic partnership with a leading healthcare and diagnostic software solutions provider allows sponsors and other research organizations to collaborate with HCPs to derive meta-data insights from anonymized EHR (electronic health record) data from thousands of hospitals and clinics worldwide. The partnership provides access to patient records without moving or revealing any actual EHR data. This enables prognostic and predictive analysis for improved study design for more precise subpopulations of patient cohorts. In certain instances where there is patient consent, ObvioHealth may reach out to patients via their care providers to offer trial opportunities.
ObvioHealth typically pre-screens from a landing page that details the study basics and includes the relevant pre-screening questions. From there, if the participant qualifies and, if needed, they are sent an invitation to register for a more detailed screening.
By eliminating geographic boundaries, ObvioHealth gives access to clinical trial to people who would otherwise not be solicited: those who live too far from a lab or clinic and aren’t registered in a patient catalog but may be suffering silently with a disease. Given the chronic problem with the under-representation of minorities and specific demographics in trials, virtual recruitment is an important step to breaking down these barriers.
ObvioHealth's average virtual trial recruitment length is less than 3 months when the average traditional trial recruitment length is 12 months. In recent recruitment for a digital therapeutics study, the sponsor assumed a 24-week timeline. The study was fully recruited in 6 weeks.
ObvioHealth has a few options that can be incorporated for identity verification. We can scan the barcode on a government issued ID or passport and authenticate the subject in over 155 different countries. We can request that subject submit a picture of themselves (with specific parameters) with the government ID. We can also initiate geofencing and/or GPS authentication to confirm the location of the subject. We also utilize the biometric capabilities on the newer devices, like the Apple face ID or fingerprint ID. Lastly, We can also utilize a query based approach similar to what the big banks use to verify identity with a series of questions that identify the participant.
Participants can review the electronic informed consent (eIC) via the ObvioHealth app before confirming their understanding of rules and protocol requirements and intent to participate. Since this is a digital process, participants can review the eIC at their own speed and ask questions as necessary. We have the ability to build in quizzes through the consent process by asking very simple consent-related questions to the participant to ensure full understanding of the content.
ObvioHealth has a tiered screening process. After participants have completed a pre-screener to establish basic eligibility and have gone through the eConsent process, they have an overall view of the study commitments. The eScreener, downloadable in the ObvioHealth app, then asks more detailed questions to address all study eligibility criteria. Screening questions can, with participant consent, be integrated with EHR, medical history, and other outpatient data to provide a fuller picture of patient eligibility and, in some cases, avoid the need for additional testing.
Both video and written device training have been developed by the ObvioHealth training team. In additional, versions of those training materials have been optimized for the end user: study team versus study participant. For the study team, a training video is provided to give general device details and a step-by-step overview of the device activation and registration process. The site is also provided access to the ObvioHealth support team, who is available to assist during the registration process.
Prior to enrollment, a training video detailing each of the five study devices is presented to the study participant in the ObvioHealth app, with a follow-up quiz to confirm comprehension and help target any areas that were unclear. The device training videos are then available to the participant on demand via the ObvioHealth app throughout the duration of the study. In addition to the video, the participant is also provided with written support both via the app and in paper form. In real time, as the measures are expected to be collected, participants are reminded which measures to take via the ObvioHealth dashboard and can click on their reminder task for a quick overview of how to use the device and collect the required measures. In addition, the ObvioHealth training team created a paper 'cheat sheet' with the same overview that can be referenced outside of the app.
Each participant will be emailed a participant I.D. number used to log into the app and access individualized study information. Participants will have access to a messaging feature within the app, which allows direct communication with the study staff for troubleshooting.
ObvioHealth has relationships with multiple shipping vendors who enable us to package and ship study products around the globe. The platform is flexible, so sponsors can "BYO" shipper or ship their own products if desired.
ObvioHealth's DCT platform supports the integration of several FDA-cleared devices that are shipped to the participant's home. Device returns can also be coordinated through the platform.
ObvioHealth has a stipend program for participants that is entirely virtual. Participants are paid according to the achievement of milestones. The app provides real-time tracking of patient eligibility for payment.
Our global payment system is available to participants anywhere in the world, making gift vouchers available in local currencies. Central management and distribution increases compliance and provides automatic tracking for regulatory purposes. Everything is electronic, trackable, and compliant.
ObvioHealth has several options for studies requiring specialized evaluations. We can partner with clinics or labs to perform the evaluations. We can send healthcare providers into patients’ homes or, in some cases, it may be possible to conduct the evaluations via telehealth visits. The team works with the study sponsor to determine the best approach for each study.
When study protocols require professional medical assessments, the goal should be to make the process as easy as possible for the patient. ObvioHealth's app makes it easy for participants to connect with HCPs. They can use the app to schedule required appointments.