ObvioHealth FAQ

How can participants access the DCT platform ?

Participants can use their own smartphones or tablets with a downloadable app to access all platform features. So there is no need to carry around an extra device such as a study-issued phone or tablet. Having all data collected and provided through one system means the Obvio app eliminates the inefficiencies in current studies where data is collected and provided through multiple disparate systems.

Is ObvioHealth’s platform available on both Android and iPhone?

The ObvioHealth app is available for download on Android and iOS devices via the Google Play or App Store, respectively, and works on 99% of devices.

Is ObvioHealth’s platform BYOD ("bring your own device") or do you provision devices?

ObvioHealth follows a bring-your-own-device (BYOD) model. Participants can use their personal smartphone or tablet to access the app and complete study-related tasks. This model leads to enhanced study results through comprehensive data capture and eliminates inefficiencies of data being collected through multiple disparate systems.

Does ObvioHealth’s DCT platform have chat and messaging capabilities?

The ObvioHealth app offers a robust messaging capability that allows staff members to communicate with study participants in real-time. The transcript of the interaction is documented and maintained as part of the study record. The ObvioHealth COACH (Clinical Oversight And Coordination Hub) team is available via the chat function in the app for questions or concerns arising at any time during the study. If preferred, participants can also communicate with study personnel via email or telephone. Data from four recent studies showed that 100% of participants had communicated via chat with the study coordinators. Contrary to frequently-held assumptions, only 1 out of 5 of those conversations were questions related to the technology.

Does ObvioHealth’s DCT platform have the ability to send reminders and notifications?

The ObvioHealth app is participant-centric in design and has in-built reminders and notifications to ensure compliance throughout the active study period. Reminders can be programmed based on the study protocol and notifications will be delivered to participants when eDiary and other tasks are available to be completed.

What are the international capabilities of the ObvioHealth DCT platform?

ObvioHealth has a proven global implementation track record, with over 40 studies launched to date in 28 different countries across five continents.

Does ObvioHealth’s platform integrate ePRO, eConsent, eCOA, and EDC?

ObvioHealth's platform and app enables eConsent during onboarding, allowing participants to review important details at their own pace and ask questions accordingly. User-friendly ePRO in the form of questionnaires, diaries, and scales make it easy for participants to enter their data at the moment an event occurs. The platform also integrates eCOA and eClinRo capabilities, enabling physicians and clinicians to collect high quality electronic data from patients.

Does ObvioHealth’s platform support study product randomization and product/device shipping/tracking?

ObvioHealth’s platform has been designed to automate randomization according to protocol specifications. Our logistic management system arranges for home delivery of investigational study supplies and devices, ensuring that these arrive punctually and reliably at participants’ homes. We have put safeguards in place to make the process as seamless as possible, including the confirmation of the right product via scanning of the tracking code. Everything is triggered, tracked, and managed end to end.

Does ObvioHealth support site-based visits in clinical trials?

ObvioHealth does not conduct site-based visits. Rather, when site-based visits are necessary, we partner with a CRO to conduct them. We do provide virtual site visits for elements of the trial that can be conducted remotely. ObvioHealth has a native cloud-based EDC that captures all site-based data such as eCRFs and eClinROs and can integrate with external data streams such as labs and imaging.

Does ObvioHealth’s platform support telehealth visits?

The ObvioHealth platform can support telehealth visits. We offer chat messaging as well as audio conference capabilities. Our Principal Investigator as well as our Study Coordinators provide the support to handle specific participant questions, issues, and concerns.

It is possible to schedule labs and doctors' visits via the ObvioHealth platform?

ObvioHealth's app makes it easy for participants to connect with HCPs. They can use it to schedule on-site visits, HIPAA and Part 11-compliant telemedicine visits, home health visits, and labs or imaging. Appointments are integrated into the app's calendar and proactive reminders are sent to confirm them.

What are the protocol considerations in DCT?

Whether fully virtual or hybrid, DCT trials are designed with the end in mind. Trial designers begin by establishing a clear overview of how all the component parts of the study fit together. ObvioHealth’s innovative technology facilitates easy study design. Our modular platform offers a continuum of microservices with a built-in EDC, enabling us to more easily adapt to each project’s parameters. Options are pre-configured, minimizing the need for customized programming, with positive impacts on both timing and budget.

Do you have access to real-world data to inform protocol design?

ObvioHealth is bringing clinical trial data fully into the continuum of care through a new strategic partnership with a leading healthcare and diagnostic software solutions provider in Europe. The partnership will unite ObvioHealth’s proprietary decentralized clinical trial tools with the partner's software solutions, connecting the dots between clinical research and EHR (electronic health record) data while supporting healthcare providers from thousands of hospitals and clinics across the world to deliver care to hundreds of millions of patients. The initial stage of the partnership will allow sponsors and other research organizations to collaborate with HCPs who can provide meta-data insights from patient records without moving or revealing any actual EHR data. This will enable researchers to conduct granular prognostic and predictive analysis for improved study design and recruitment of more precise subpopulations of patient cohorts, giving healthcare professionals and their patients the opportunity to contribute to and/or participate in research, while maintaining full control of their data, in compliance with stringent European privacy and data safety regulations.

Do you have a library of validated questionnaires/tools?

We use and  deploy validated questionnaires. However, in our experience, there is always a need for adaptation to the specifics of a study. Direct migration of a Q&A from paper to a digital is infrequent because of the needs for tailoring to the study and the quality control associated with testing.

Is your platform configurable and/or customizable?

The ObvioHealth app’s advanced, user-friendly features and inherent flexibility can be quickly configured or deeply customized according to the specific requirements of each study protocol, making it the ideal platform for any hybrid or 100% virtual clinical study.

What methods are used to recruit participants/patients?

ObvioHealth studies are recruited primarily through digital advertising and social media outreach (e.g., Facebook, Instagram, and YouTube), implemented and overseen by an expert in-house campaign manager. The digital media platforms allow ObvioHealth to reach a broader and untapped pool of potential subjects with precision targeting. Interested patients are directed to a custom landing page for the study, shown in the target's language. Pre-screening questions can be made available on this page. Based on the screening questions, eligible participants are sent an email with a unique participant ID and instructions on how to download the ObvioHealth app. The result is faster more cost-efficient recruitment as well as a more diverse population. Additional recruitment strategies (e.g., at clinic sites) can be employed, if desired. For some challenging studies, ObvioHealth has a new partnership that enables us to query electronic health records of certain cohorts and then work with their providers to offer them the opportunity to participate. In all cases, sponsors are given access to real-time recruitment metrics via a web portal. The outcome is better coverage and participant reach.