Decentralized clinical trials are transforming the clinical research industry. And, with change comes new questions and uncertainties for trial sponsors like you. Let us equip you with answers so you can make smart decisions about your trial design.
Get AnswersHow virtual can my study go?
Every sponsor wants their study to have high compliance, adherence, and retention rates, while also collecting the necessary data to meet desired trial outcomes. Most trials will require some combination of traditional trial elements and decentralized components. The decentralized modules help to reduce patient burden and facilitate remote data management and monitoring. Studies that require face-to-face medical oversight or intervention can also employ certain decentralized elements to minimize on-site activities.
If your primary endpoint is ePRO-related or can be accurately captured remotely by an in-home device or home testing kit, your study may be appropriate for a 100% virtual design.
Some trials will require site or doctor’s visits but can still benefit from integrating virtual methods. The goal is to identify touchpoints that can be enhanced with decentralized solutions.
Find out whether hybrid or full DCT best suits your protocol
Get More AnswersCan a DCT deliver the level of data accuracy my study requires?
We know that capturing quality outcomes and effectively monitoring the safety of a clinical trial requires more than traditional ePRO solutions can offer. Our clinically focused technology platform reduces friction in outcomes capture, reduces patient burden, and leads to more reliable endpoints.
One of the most important elements in ensuring data accuracy is the ability to capture data in real time. No parking lot syndrome on our trials. The ObvioHealth app enables patients to report symptoms as they experience them.
Attention to data accuracy is designed into every detail of ObvioHealth’s next-generation platform, tools, and processes, enabling us to not only meet but surpass the data accuracy typically delivered on a traditional trial. Our clinical science expertise is brought to the fore during the design phase to ensure that the right instruments are used to get to the right endpoints.
The data from patients is immediately transferred to ObvioHealth’s customized dashboard where it can be viewed in real time by our COACH (Clinical Oversight And Coordination Hub) team. If there is straightlining, missed reporting, discrepancies between device and ePRO data, or if we see other anomalies, our support teams reach out to patients in real time for clarification.
Our data science team ensures the quality of data analysis at the back end. 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. And, because our data is all in one place and minimal data cleaning is needed at the end of a study, our average time between LPO and database lock is 7 to 10 business days.
It is essential to train patients on concepts such as accuracy and honesty in reporting, as well as the importance of ePRO compliance and medication adherence. 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.
Can DCTs maintain patient engagement?
ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team is an essential part of our recipe for success. Our CRO roots have taught us that tech alone can’t deliver solid study outcomes. The tech can make participation easier and less burdensome. But, strong patient engagement requires both Tech and Team. Participants need a human connection—someone they can easily reach out to with question… a real person at the other end of the study to whom they feel accountable. ObvioHealth has designed our tools to be run by our own experienced in-house team. The platform facilitates the team’s providing of support and assistance and the real-time monitoring of adverse events. Integrated devices capture data on vital signs which can be visualized in real time on data dashboards. Our Tech + Team approach to DCTs results in higher retention and adherence.
88%
Percent Retention Rate
Percent of participants enrolled in an ObvioHealth trial that complete the study
90%
ePRO Completion Rate
Percentage average of ePRO Completion Rate in completed ObvioHealth studies
How can I ensure patient safety?
Patient safety in a clinical trial begins with the careful review and approval of a protocol and continues through ongoing monitoring to ensure that potential risks are anticipated and that a system of alerts is put in place to address issues as soon as they arise.
Real-Time Reporting and Monitoring
In a traditional trial setting, a patient leaves a site, and, many times, the adverse event only comes to light at the next visit. The ObvioHealth platform enables real-time monitoring of adverse events. Patients respond to a daily question on the app to determine whether anything in their medical status has changed. If affirmative, the system asks further questions to capture the scope of the issue. Integrated devices also offer the option of capturing data on vital signs which can then be visualized in real time on data dashboards.
Immediate AE Detection and Resolution
This data from the patient is immediately transferred to custom-built dashboards where it can be viewed in real time by ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team. If an AE is suspected, the team will follow up with the patient personally and create an electronic case report. We use Med Dra to code each event in the back end. We can also export AE/SAE data to sponsor databases.
On-Demand Virtual Site Team
Participants can make contact with ObvioHealth’s COACH team at any time. They can choose their preferred communication method—chat, email, or phone—ensuring they get the information they need when they need it.
Deep Clinical Operations Experience
At ObvioHealth, we believe experience is key. We have developed and validated over 250 ePRO/PRO solutions across various therapeutic areas, leading to successful outcomes and endpoints.
17 Therapeutic Areas
Over the past 5 years, we have worked across 17 therapeutic areas, enabling us to gain powerful insights into how to adapt decentralized trials to specific protocols.
Client Roster
In this short time, 7 of our 21 clients have given us repeat business—the greatest proof of satisfaction.
40+ Studies in 28 countries
ObvioHealth is a truly global organization. We have run trials in 28 countries across 5 continents.
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