FAQ Categories

Decentralized Clinical Trials

Why ObvioHealth?

Platform Functionality

Study Design and Set Up

Recruitment

Enrollment and Onboarding

Logistics Management

Data Capture/ Outcomes Measurement

Study and Clinical Oversight

Data Management, Visualization & Reporting

Security, Data, & Regulatory Considerations

Frequently Asked Questions

Decentralized Clinical Trials

What is a decentralized clinical trial (DCT)?

A decentralized clinical trial is one where technology is used to communicate with study participants and collect data. This can take many forms, from electronic patient reporting (ePRO) to remote monitoring or telehealth visits.  Other terms often used interchangeably with DCT are Virtual or Remote Clinical Trials.

What are the benefits of decentralized clinical trials (DCT’s) compared to traditional trials?

Decentralized Clinical Trials have significant benefits for both patients and sponsors. For patients, DCT's make the trial more convenient, reducing the burden to participate. The ObvioHealth app on a participant’s personal smartphone is almost always on hand so they can report from the comfort of their homes or, if a medical assessment is needed, a telehealth or home visit can be organized.

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What is the difference between a 100% remote/decentralized trial and a hybrid trial?

A fully decentralized clinical trial enables participation without having to visit sites; study participants can do the entire clinical trial from their homes. They can give electronic informed consent, have their study product shipped to them directly, report via their app, and use devices to capture vitals remotely.

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How are site responsibilities handled in a decentralized clinical trials (DCT)?

In a Decentralized Clinical Trial, site responsibilities are typically centralized around a remote team, or they can also be shared with traditional sites when the study is hybrid.  In the case of ObvioHealth, the COACH (Clinical Operations And Coordination Hub) performs many of the same functions as a traditional site but does so remotely.

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Do decentralized clinical trials (DCT’s) work better for certain therapeutic areas?

Components of Decentralized Clinical Trials can be used for studies in just about any therapeutic area where patients are not hospital-bound.  ObvioHealth is currently conducting DCT's in 17 different therapeutic areas.

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What determines whether a study can go remote/virtual?

The ability to go remote depends on the study objectives, the corresponding requirements of patients, and the outcomes that you're expecting to get from the study. We work very closely with sponsors to design the best solution for their needs.

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Are decentralized clinical trials (DCT’s) more suitable for certain phases of research?

DCT's can be utilized for all phases of the study. To date, they have most often been used for Phase 2 and 3 studies.  ObvioHealth has experience across the globe in late phase one, early phase two, phase three and post-marketing and medical marketing type studies where we're asking participants specific questions around consumption and efficacy of a product.

Does using a decentralized trial model affect the FDA approval process?

A decentralized clinical trial model involves the use of the same rigorous process, standards, and guidance by the FDA as a traditional site-based clinical trial, including standards for electronic data capture and ePRO collection.

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Are there targets that have more difficulty with the requirements of decentralized clinical trials (DCT’s)?

The best Decentralized Clinical Trial  technology is designed to be simple to use. Patients of all ages have been able to manage ObvioHealth's technology with ease. The training videos are very clear and the participants are able to ask the COACH (Clinical Oversight And Coordination Hub) team any outstanding questions through phone, email and chat.

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What is ObvioHealth?

Are you a CRO?  A software provider? A site?

ObvioHealth is all 3. We are a Virtual Research Organization  leading the virtual clinical trial revolution. As a boutique CRO, we have been running decentralized trials end to end for biotech, consumer health and digital device innovators since 2017.

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What makes ObvioHealth’s approach to clinical trials unique?

ObvioHealth's decentralized clinical trial platform is designed end to end as a unified data repository for virtual or hybrid research. When designing the platform, we set about modernizing each step of the trial process, from onboarding to logistics  to outcomes measurement and reporting. At each step along the way, we identified the impediments to efficiency. We also knew that even great software, would be insufficient to deliver successful studies.  So rather than focus solely on the tech, we designed our tools to be run by our in-house COACH (Clinical Oversight And Coordination Hub) team, putting them at the center of our virtual system. The results is a platform and team that is both patient and sponsor-friendly.

What are ObvioHealth’s products/services?

ObvioHealth's products include our Virtual Clinical Trial Platform and BYOD app. Within this, we are able to offer targeted digital recruitment services, RWD mining for study design optimization, eConsent, participant, site and expert rater training, provider assisted recruitment and enrollment, study product and device shipment and tracking, ePRO including audio and image capture, remote patient monitoring, eClinRo, data analysis, visualization, and reporting.

What therapeutic areas does ObvioHealth have experience in?

ObvioHealth has worked across 17 therapeutic areas covering pharmaceuticals, medical devices, and nutrition. These include: Cardiology, Oncology, Respiratory, Men's and Women's Health, Dermatology, GI, Hepatology, Mental Health, Oral Health and Infectious Disease (COVID19).

Where does ObvioHealth’s operate/run trials outside of the US? What is your international coverage?

ObvioHealth has been global from the outset.  Countries where we run trials, include Australia, Bangladesh, Canada, Colombia, Czech Republic, Dominican Republic, Estonia, Finland, France, Hungary, Indonesia, Italy, Latvia, Malaysia, Mexico, New Zealand, Norway, Peru, Philippines, Romania, Russia, Singapore, Spain, Sweden, Thailand, and the United States.

How does the quality of your data compare to would be collected by a site?

Sponsors are recognizing that decentralized clinical trials, when planned and conducted properly, can deliver better data than traditional site-based trials.

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How does ObvioHealth’s approach to trials improve patient engagement and compliance?

Since patients can participate from the comfort of their homes, they are less burdened than in trials where they need to travel, sometimes long distances to a site.

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Platform Functionality

How can participants access the DTC 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 DTC 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.

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

The Obvio 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 DTC 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 & eClinRO’s and can integrate with external data streams such as labs &  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.

Study Design and Set Up

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.

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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.

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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 Obvio 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.

Recruitment

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.

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Do you work with sites to recruit providers?

ObvioHealth has a list of preferred sites and providers that may be invited to participate in a clinical trial.

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Do you use EHR/EMR data for recruiting?

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.

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How do you pre-screen the patients?

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.

What is your approach to increasing diversity in your trials?

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.

How do your recruitment timelines compare to traditional trial recruitment methods?

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.

Enrollment and Onboarding

How do you prevent fraud when enrolling participants?

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.

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How do participants provide consent in a decentralized trial?

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.

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What is your screening process ?

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.

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What kind of training do you provide?

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 vs. study participant.

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How do you manage participant questions during the enrollment process ?

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.

Logistics Management

Shipping

How do  you handle the shipment and tracking of study product?

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.

Do you provision home health devices?

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.

Stipends

Are participants remunerated in your trials?

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.

Are you able to pay stipends to participants in different countries/currencies?

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.

Medical Assessments

What if a study requires highly specialized evaluations?

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.

Can participants schedule doctor’s  visits through your system?

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.

Are doctor’s visits done remotely or face to face? In clinic or in home?

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.

How are lab visits completed in a Decentralized Clinical Trial ?

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.

Data Capture/ Outcomes Measurement

Do your trials incorporate ePRO/eCOA?   

We offer a range of technologies that enable more manageable and more accurate data collection, including next-generation ePRO and eCOA.

What kinds of data can be collected through the platform? 

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.

How do you ensure that the data is accurate?

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.

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What happens if data is entered when the platform is offline?

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.

What sort of medical devices, sensors or wearables does your platform support?

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).

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How do you prevent participant bias when reporting data?

Patient, caregiver, and site rater training is key to limiting bias in studies, as it reduces variability in reporting while minimizing interpretation bias.

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Study and Clinical Oversight

Who manages a Decentralized Clinical Trial?

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.

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What is the role of the sites in a Decentralized Clinical Trial ?

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.

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How is the PI oversight ensured during the course of the study?

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.

How do you manage participant questions? Is there a help desk?

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.

How do the study coordinators communicate with participants?

The ObvioHealth platform and app offer multiple options for communication between participants and study coordinators.

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How is site training managed?

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.

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How can the patient contact the site in case of questions ?

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.

Data Management, Visualization & Reporting

How does the ObvioHealth platform integrate with other stakeholder data (sponsors, sites, labs)?

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.

Does the system support the transfer of data into a CTMS?

Sponsors can access their projects through the sponsor portal of our Clinical Trial Management System (CTMS). Our CTMS maintains and manages the planning, performing, and reporting functions, along with tracking project deadlines and milestones.

Which EDC system is used for your trials?

The ObvioHealth platform has its own proprietary, validated EDC system.

What are your data management/cleaning procedures?

ObvioHealth performs automatic data cleaning, auto-edit checks, and advanced query resolutions as the data is entered, enabling us to more quickly advance to analytical review.

How long does it typically take between LPO and database lock?

The typical time for an ObvioHealth data lock is about 30 days. In some cases and because of our technology, we have been able to reach database lock in as little as 2 weeks.

How do you back up the data?

ObvioHealth has implemented technical and administrative controls which meet  ISO standards to address data continuity, including Data Classification, Source Data Control, Data Backup & Recovery, High Availability/Disaster Recovery, and Archival policies. These practices ensure that study data is continuously backed up throughout the study.

Do you have a source document audit trail of all data recorded or modified ?

The ObvioHealth platform includes a proprietary EDC system. Any time a data point is entered into the system, it is fully auditable. The audit trail is fully compliant with ICH GCP standards and is downloadable.

Does your system produce an Electronic Trial Master File (eTMF)?

Our cloud-based EDC system manages and cleans data in real-time and resolves queries, includes a complete clinical trial management system (CTMS), and an electronic trial master file (eTMF). The sponsor can get direct access to the eTMF during and after the study.

How can sponsors access data reports?

Sponsors have access to the study dashboard through a secure webpage which enables them to view all activities and requested analytics in real-time with capabilities to download, print, and review information offline.

What options are there for data exports at the end of the study?

Our backend portal allows us to track all the participant information: number of enrolled, completed number, number of patients withdrawn, etc. Sponsors can access our backend portal for real-time information any time that they want to. They can export the questionnaires, and all data is readily accessible for accurate analysis.

Security, Data, and Regulatory Considerations

What regulatory standards does your platform comply with?

The ObvioHealth platform has been developed to be consistent with the design, quality, and security controls associated with the regulatory requirements of HIPAA, GDPR, 21 C.F.R. Part 11, ISO 27001, 27017, and 27701. ObvioHealth received certification in ISO/IEC 27001:2013, ISO/IEC 27701:2019, ISO/IEC 27017:2015, and HIPAA in May 2021.

What is your regulatory compliance process?

ObvioHealth has significant experience conducting studies that are compliant with global regulatory requirements. The ObvioHealth platform is 21 C.F.R. Part 11 compliant, and its use for clinical studies or research study management is compliant with all regulatory requirements and guidelines, including ICH-GCP. We have begun external audit and preparation for ISO 27001, 27017, 27701 certifications.

How are submissions to IRBs and other regulatory agencies conducted?

ObvioHealth offers oversight and management of all required regulatory submissions for projects within and outside of the U.S. We work with local IRB’s and the ministries of health to obtain proper approvals. Our system company has extensive regulatory experience outside of the U.S. and can be engaged as needed.

Does using a decentralized trial model affect the FDA approval process?

The FDA has identified the modernization of clinical trials as an agency-wide priority and voiced commitment to creating a regulatory framework supportive of innovative approaches to research. As such, the FDA does not penalize the use of decentralized methodologies during the drug development process so long as all regulatory guidelines are followed.

How do you store patient data?

All patient data is stored in a secure database restricted to only authorized ObvioHealth clinical staff and is encrypted, password-protected, and controlled per the highest encryption and compliance standards.