ObvioHealth announces upgraded decentralized trial platform
ObvioHealth has introduced a new platform that enables advanced remote-patient monitoring capabilities for decentralized trial solutions. The company’s decentralized platform and patient-centric smartphone app are designed to help create an ‘ecosystem’ of technology and devices approved by the US Food and Drug Administration (FDA) to support remote monitoring and patient connections with the help of the app.
Through partnerships with other companies like BioIntelliSense, AliveCor and iHealth, trial teams can remotely monitor up to 20 different vital signs, such as heart rate, respiratory rate, temperature, blood pressure, oxygen saturation, ECG, coughing episodes, sweat, sleep, activity levels and body positioning. Data from the devices is transmitted to the ObvioHealth clinical trial platform, where it is centrally and continuously monitored, enabling immediate identification of adverse events and reducing time to response.
Ivan Jarry, ObvioHealth CEO, spoke to Outsourcing-Pharma about the platform, smartphone app and what the new technologies mean for the future of decentralized trials.
OSP: Could you please share the ‘elevator presentation’ description of ObvioHealth—who you are, what you do, and what sets you apart from the competition?
IJ: ObvioHealth is a global virtual research organization that developed and launched the first patient-centric app for clinical research, enabling people to participate in clinical trials from the comfort of their homes and empowering our virtual clinical operations team to communicate directly with patients.
We built ObvioHealth from the outset as a digital platform, conceived and run by a virtual in-house team. Our competitors include the legacy CROs that are now scrambling to digitize by acquiring other companies’ software and retrofitting it into their systems to go virtual. Not surprisingly, this retrofitting can result in study designs and workflows with incompatibilities and gaps.
ObvioHealth’s cloud-native and modular design was built to enable easy integration of every component part of a study, from recruitment, through enrollment, data capture to data cleaning and analysis – which is why we are able to build, implement and deliver our end-to-end trials so seamlessly.
Another differentiator is our team. Our tech competitors are generally software companies that have designed systems for use by CRO’s, whereas our business model combined tech and team -- platform and service from the outset.
The ObvioHealth platform was built as a collaboration between our brilliant tech team, many of whom are serial tech entrepreneurs, and our amazing clinical operations team with deep expertise in conducting clinical trials. The result is a platform that makes sense and is easy to use, both for participants and for sponsors. And that same clinical operations team uses the platform every day. This ongoing experience with the platform allows ObvioHealth to learn and optimize as we go, delivering outcomes with increased efficiency and accuracy.
OSP: Then, could you please tell us about your next-gen platform, and how it stands above similar decentralized trial and remote monitoring solutions?
IJ: We believe our platform and ecosystem provide the most complete and greatest breadth of remote monitoring options currently available. While our most recent announcement leveraged our vitals monitoring capabilities, we have many other data capture tools and combined they make for a very powerful ecosystem.
Our smartphone app makes it easy for patients to report how they’re feeling, along with any changes in health status. The data within our app is constantly monitored by the study investigator for potential issues, such as medication adherence or an adverse event. This allows us to immediately contact the participant to provide support via chat, email or a phone call with the study coordinator.
Or, if necessary, ObvioHealth’s unified platform enables easy and convenient HIPAA and Part 11-compliant telemedicine visits with study participants. We also have audio and image capture capabilities that complement and sometimes replace the need for questionnaires.
For example, one recent observational trial asked mothers to take a photo of their babies’ soiled diapers and upload them into our app. Instead of the mothers telling us what their babies’ stools look like, they were able to send us the actual and more accurate image. All of these capabilities offer a rich combination of behavioral and device-based data to deliver more accurate outcomes.
Our platform has already been deployed in studies across 22 countries. We are a global organization with offices in Australia, Singapore, Europe and New York. Our global expertise helps us to successfully work with different regulatory bodies around the world.
OSP: Could you please tell us about your partnerships with BioIntelliSense, AliveCor, iHealth and any others—what are the organizations bringing to the table?
IJ: These devices bring a level of monitoring that is equivalent to a hospital room, but instead, the patient is at home. We can track more than 20 vitals enabling us to offer a more holistic picture of a patient’s health than other DCT platforms.
Specifically, these devices offer greater granularity vs. previous remote monitoring options. For example, AliveCor delivers 6 lead vs. the more typical 1 lead for ECG devices. BioIntelliSense offers continuous monitoring for 30 days with easily replaceable patches to extend monitoring 30 days at a time. BioIntelliSense also brings us the ability to monitor a few unique vitals such as coughing episodes, prone position, and activity levels. iHealth offers a portfolio of peripheral devices that let us round out vitals, depending on the study.
This means studies that once required frequent patient touchpoints at a clinic can now be conducted virtually. It also means trials with this level of remote patient monitoring are safer because we can detect adverse events immediately. In a COVID-19 study, for instance, if a patient’s temperature rises and their respiratory rate drops, our platform will alert the study team immediately and we are able to contact the patient in near real time.
OSP: Could you please talk about the possibility of achieving fully decentralized, siteless trials—is that within reach? What sorts of technologies and capabilities do trial organizations need to have in place to achieve that?
IJ: We know we can achieve fully decentralized trials because we already have done over a dozen of them. We are currently conducting a clinical trial of a medical device for the treatment of female pelvic floor disorders that does not include a single site visit.
We are conducting a COVID-19 treatment study that includes only one site visit at diagnosis. Patients are diagnosed with COVID at a clinic and then sent home with digital monitoring devices and an investigational drug. They never return to the clinic; instead, their vitals are monitored by digital and wearable devices, they report their symptoms using our patient-friendly app, and they receive home healthcare visits from nurses.