ObvioHealth’s DCT platform supports multiple options for doctor’s visits including virtual (telehealth) visits, home health care visits, and clinic visits. Some studies may enable patients to choose the option that is most convenient for them. The ObvioHealth team works with sponsors to identify the protocol that best fits the study needs.
Participants are reminded via the app when they are required to schedule a lab appointment. Scheduling is easy; the participant will pick a time/date and location that works best for them. All data collected during the appointment is entered directly into the ObvioHealth platform and database.
We offer a range of technologies that enable more manageable and more accurate data collection, including next-generation ePRO and eCOA.
The platform will capture information relevant to endpoints identified in the protocol. This might include medical history, concomitant medication use, study kit/device data, and study visit/time point assessment data. The platform is also capable of image, audio, and visual capture.
One of the most important elements in ensuring the accuracy of data is to capture it in real-time. This avoids parking lot syndrome, where patients forget to report until right before their site visit and then try to remember and report at the last minute. Another key to accuracy is the ease of reporting. The Obviohealth app is designed to be very user-friendly. Our COACH (Clinical Oversight And Coordination Hub) Team also plays a key role in monitoring patient reporting. If there are clear discrepancies between patient conditions captured through devices, images, or chats and results from questionnaires, this is noted. We monitor anomalies in the data in real-time. Finally, the platform has its own checks and balances to ensure the accuracy of data. We perform automatic data cleaning, auto-edit checks, and advanced query resolutions as the data is entered. This improves our ability to quickly identify discrepancies that might suggest a change in behavior or user.
Data can be entered when there is no access to the internet. Then, when a wi-fi or other connection is established, the data will be automatically uploaded into the Obvio Platform.
The Obvio platform and app are fully configurable to a sponsor’s study protocol, including connectivity to 3rd party external devices and systems (i.e., smartwatches, activity trackers, medical devices including sensors wearables and digital biomarkers). Assessment data is pooled with and available for viewing on the Obvio Data Dashboard. Our clinical and tech teams assess which FDA-approved device is most appropriate to deliver endpoints. At present, we have an ecosystem of devices measuring over 20 vital signs and regularly assessing new instruments. The platform also integrates image, audio, and video capture to reduce the reporting burden of patients while providing rich unstructured data for analysis.
Patient, caregiver, and site rater training is key to limiting bias in studies, as it reduces variability in reporting while minimizing interpretation bias. It is essential to train patients on concepts such as accuracy and honesty in reporting, the importance of ePRO compliance, and medication adherence. ObvioHealth researchers have found that educating patients about the placebo effect can reduce placebo response rates by over 50%. In addition, subjectivity is reduced whenever possible by using patient images, audio, video or wearables and biosensors to ingest patient data streams. Patient data can then be reviewed and scored by central expert raters to reduce inaccuracy in reporting.
ObvioHealth has an experienced internal team that manages all DCT's. The Project Directors assume responsibility for their study and ensure that the right resources are deployed to meet the proposed milestones. Project Directors are the critical link between the sponsors' team, any sites (including the ObvioHealth COACH (Clinical Oversight and Coordination Hub) team, any third-party vendors, and the Obvio Platform development and management teams, all of whom work as one collaborative and cohesive unit.
In our decentralized clinical trials, data capture most often does not require visits to a clinic but is rather completed at the participant's home via the app. Responses are automatically uploaded to our platform and reviewed by our virtual site or COACH (Clinical Oversight And Coordination Hub) team. In the cases where a doctor or lab visit is required during the trial, the ObvioHealth app facilitates scheduling with medical professionals as well as labs or imaging networks. Appointments are integrated into the app's calendar and proactive reminders are sent to confirm appointments.
ObvioHealth's Principal Investigator (PI) is responsible for ensuring patient safety, overseeing protocol compliance, and maintaining patient engagement. The PI monitors reported health changes and vitals information for potential adverse and serious adverse events (AE/SAE) and encourages frequent interaction between the patient and study staff.
ObvioHealth's COACH (Clinical Oversight And Coordination Hub) team is the ultimate help desk. They are available to patients throughout the trial to answer questions and address any concerns.
The ObvioHealth platform and app offer multiple options for communication between participants and study coordinators. Participants can choose their preferred option: chat, email or phone, ensuring they get the information they need when they need it. The app enables participants to quickly report any health status changes - often with a few taps of a button. The COACH (Clinical Oversight And Coordination Hub) team can then reach out to them to address any questions or concerns.
ObvioHealth has a comprehensive site rater and staff training program. Site raters and staff are trained online using virtual interactive digital multimedia with comprehension quizzing, qualification, and accreditation. ObvioHealth uses a single sign-on process where site raters and staff log in to the ObvioHealth web-based study portal and are guided to the training (LMS)on. Once training is completed, site raters and staff can begin using the study portal and completing their assessments in the digital environment. In addition, site initiation visits are conducted at every site included in the study. Completion guidelines and other supporting materials are distributed to provide ongoing support throughout the study. The completion of initiation visits is tracked as part of the study process.
Participants have access to a messaging feature within the app that allows direct communication with the centralized COACH (Clinical Oversight And Coordination Hub) team for support at any point in the study. ObvioHealth's Principal Investigator is also available for any medical questions.
The ObvioHealth unified platform has full in-house EDC capabilities. Our site portal enables sites, labs, and other stakeholders to enter data directly onto our platform. The platform also enables integration with wearables, medical devices, and remote patient monitoring across a wide spectrum of clinical measures as well as several other sources like EHR's and labs.