Introducing Augmented ePRO: next-generation ePRO and centralized expert rating platform Learn more.
Introducing Augmented ePRO: next-generation ePRO and centralized expert rating platform Learn more.
Virtual Site Expertise. Deep Experience. Clinically Focused Tech.
Choosing a clinical trial partner can be daunting—all the more so when trying to decentralize all or part of a study. We’ve cut through all the noise to make trial decentralization more accessible. ObvioHealth clients appreciate our pioneering technology as well as our teams of experienced clinical researchers and supportive study coordinators. This is our winning prescription for seamless clinical trials.
Meet our Team. See our Tech.
Our Tech & Team drive higher retention, compliance, and adherence rates for trials that are more likely to be completed on time and on budget.
89%
Percent Retention Rate
Percent of participants enrolled in an ObvioHealth trial that complete the study
90%
ePRO
Percentage average of ePRO compliance in completed ObvioHealth studies
Virtual Site Expertise.
ObvioHealth’s COACH (Clinical Oversight And Coordination Hub) team operates in the same way as the clinicians you’d find at a site for a traditional trial. The difference is that our team communicates with, and cares for, patients virtually—using the cutting-edge digital technology that has been put at their disposal.
Built-for-Purpose Tech.
Our platform has been developed by clinical scientists and healthcare technologists to capture better outcomes by reducing friction. It incorporates real-time safety monitoring and delivers more reliable endpoints.
Experienced Clinical Team.
As one of the first companies to launch decentralized trials, ObvioHealth has been recognized by Everest, Scrip, and DTR as a leader in the field, providing guidance based on experience, across more than 40 decentralized studies, on how to design and execute for success.
Virtual Site Team Ensures Patient Safety and 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. So, we designed our tools to be run by our own experienced in-house team. The platform enables the team to provide support and assistance, reducing the need for visits to clinics and enabling 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 COACH Team Provides
One-on-One Patient Support
ObvioHealth’s COACH team engages with patients on every step of the journey, from eConsent to data collection. They are trained to reach out to patients proactively, as well as to respond to any patient questions or concerns. Notifications and alerts remind the patient to complete study tasks. Our tech also notifies the study team when a patient is falling behind, so they can reach out on a personal level to get them back on track.
Immediate AE Detection and Resolution
Patient safety in a clinical trial begins with the careful review and approval of the 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. Patient data is tracked in real time by ObvioHealth’s COACH team. If an AE is suspected, the team will follow up with the patient personally to create an electronic case report and follow each case through to resolution.
Meet our COACH Team
With the COACH team, patients have multiple ways to stay connected and informed during their studies through virtual chats, email, or phone calls—a COACH member is always an arm’s length away.
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.
Case Study #1
Studying the Efficacy of a Medical Device on Urinary Incontinence
Pelvic floor muscle training (PFMT), or "Kegel" exercises, is considered the most effective, non-invasive treatment for stress urinary incontinence and stress predominant mixed urinary incontinence. However, more than 75 percent of women perform PFMT exercises incorrectly, even with verbal or written instructions.
Objective:
Evaluate the efficacy of a Class II digital therapeutic device compared to standard care of PFMT exercises to treat SUI/SMUI.
Methodology:
The first fully virtual study to be run in the urogynocology space, this prospective, randomized controlled study recruited participants via digital media targeting and signed them via electronic informed consent (eIC), using the ObvioHealth app to complete enrollment. Instruction material (video plus explanatory placard) was provided for the Kegel group; those in the treatment arm performed PFMT with the device's assistance.
Patients answered validated questionnaires via the app to assess changes in health outcomes. Exercise adherence, patient perceptions, and AEs/SAEs were monitored regularly via the app and visualized on live platform dashboards by our COACH (Clinical Operations And Coordination Hub) team.
There were no required office visits in this study. Upon randomization, subjects received three scheduled phone calls from the COACH team for education on PFMT exercises. For the remainder of the study, patients received additional phone calls regarding the treatment plan and safety monitoring.
Results:
Recruitment was completed with 350 participants enrolling in the trial in just 3.5 months. Regular interactions with our COACH team engaged and encouraged patients throughout the study, resulting in an 89% retention rate and a 95% ePRO compliance rate. The study delivered statistically significant results for the device versus control Kegel groups for both of the primary outcomes. We would not have had this outcome without it being a virtual study. In contrast, I was running an FI study, and drop-off was dramatic. We probably completed 60%.
- Robin Sutherland, VP of Clinical Operations
Case Study #2
Next-Generation Data Collection to Determine the Efficacy of a COVID-19 Treatment
Objective:
RedHill Biopharma seeks to evaluate the safety and efficacy of an oral investigational drug on non-hospitalized COVID-19 patients.
Methodology:
Our team of clinical researchers and software engineers designed a study to allow patients to participate from home while maintaining a high level of monitoring. Patients are enrolled through a clinical site and sent home with the study drug plus several devices to collect both telemetric and patient-reported information to measure safety and efficacy signals.
Vitals measured via devices:
• Temperature
• Respiratory rate
• Heart/pulse rates
Patients are given the option of coming back to the site or of having healthcare nurses conduct in-home visits to collect blood samples for certain laboratory parameters, perform virus PCR swabs, and verify that patients are using devices correctly.
Results:
Part A of the study is currently under way to optimize dosing. Part B is slated to begin in early 2022.
Case Study #3
Assessing the Efficacy of a New Treatment for Pre-Hypertension
Objective:
A multinational company needed to assess the safety and efficacy of a treatment for pre-hypertensive adults and those at high risk of cardiovascular disease.
Methodology:
Our clinical operations team designed a hybrid study to include remote data collection to reduce the number of site visits required in a traditional study. We were able to quickly and cost effectively reach the desired cohort through digital media recruitment by digitally targeting patients more likely to have high blood pressure (eg: had purchased a blood pressure cuff and/or had visited sites providing information on hypertension).
Emphasis was also placed on ensuring the representation of African American patients, as this population over-indexes for high blood pressure. Between site visits, subjects completed daily questionnaires and our COACH (Clinical Oversight And Coordination Hub) team tracked any changes in health status.
Results:
• Successful recruitment of a diverse population: 41% Caucasian, 39% African American, 20% other races.
• Minimization of site visits via remote monitoring facilitated the collection of 56,286 data points reviewed in real time.
• The virtual team’s regular engagement with patients helped to achieve an 89% retention rate.
Meet our Team
Our leadership team has an aggregated 135 years’ experience in designing and running clinical trials, designing and operating successful health tech platforms, and optimizing tools and diagnostics to better measure outcomes.
Ivan Jarry
CEO
Ivan has a proven track record of creating and growing 40+ companies in the health innovation space (Consulting, CRO, Digital Health, and Biotech). Over the course of his career, Ivan has consistently disrupted health categories by identifying market gaps and leading organizations to scalable success.
Craig Gravina
CTO
Craig has over 25 years of experience developing highly innovative platforms, products, and disruptive technologies within healthcare and life sciences, including a digital therapy platform for Ieso Digital and cognitive assessment solutions at Cogstate. Craig also led the development of an analytics and population health platform and portfolio at AllScripts.
Matty Culbreth-Notaro
SVP Global Operations
Matty was one of the earliest employees of ObvioHealth and brought nearly 30 years of experience in clinical research to the team. In her previous roles, Matty developed and implemented clinical research programs for multi-therapeutic area practices and hospitals across the country. She has managed advanced research programs specializing in phases I-IV, device, post-approval, observational, and decentralized clinical trials.
Scott Clark
Chief Commercial Officer
Scott brings 25 years of expertise in the pharmaceutical and CRO industries to ObvioHealth, including stints at Pfizer and Quintiles where he developed new business entities. He possesses extensive drug development expertise from preclinical through commercialization, including M&A and product/service launches on a global scale, and is a therapeutic expert in regenerative medicine, oncology, ID, and CNS, among others.
Susan Dallabrida, Ph.D.
VP of Clinical Science & Innovation
With 25+ years of experience as a leader in clinical trials, healthcare, and eClinical technology, Susan is an expert in clinical innovation. She brings to ObvioHealth her expertise in patient centricity and engagement for data capture, with a focus on improving data quality and completeness.
Dr. Parth Shah
Medical Director
Parth has over 12 years of diverse clinical and research experience in both academic and industry settings. He has served as the lead Principal Investigator (PI) and Medical Monitor (MM) across 12+ therapeutic areas and 20+ hybrid and decentralized clinical trials (DCTs).
Hawley Linke, Ph.D.
Sr. VP of Scientific Affairs
With 35+ years of experience driving science in clinical, pharmaceutical, and academic environments, Hawley is an expert in scientific affairs. She has worked at top-tier healthcare companies and institutions specializing in clinical research, laboratory-based genetic engineering, gene expression studies, virology, nutrition, technology assessment, and science and medical communication.
Marcos Dopazo
Sr. Medical Director
Marco specializes in cardiovascular diseases and emergency room medicine. Dr. Dopazo leverages his 13 years of experience to provide medical expertise and oversight for clinical trials, ensuring the clinical integrity of trial subjects and providing safety accountability across the duration of studies.
Pioneering Technology Designed for the Real World
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.
Our purpose-built app and platform incorporates a modular design that enables us to more easily adapt to each project’s parameters. We have structured the platform to provide a range of options for each step in the trial journey. Our experienced team can help you to choose and assemble the components in the best way to fit the needs of your trial. Because these options are preconfigured, the need for customized programming can be reduced, or even eliminated, with positive impacts on both timing and budget.
Our app is designed to be intuitive for patients, reducing friction and taking them step by step through the consent and enrollment processes. User-friendly questionnaires and diaries with smoother navigation make it easy for patients to enter their data at the moment an event occurs. At the push of a button, they can capture the duration, frequency, and intensity of a symptom.
ObvioHealth’s virtual environment integrates with apps and devices that enable patients to measure heart rates, blood pressure, respiration rates, weight, temperature, oxygen and glucose levels, and even allows them to take ECGs from home. Test kits, devices, and instructions are shipped to the patient, and virtual training sessions ensure they are being used correctly. This opens a world of opportunity for the more convenient capture of accurate real-time data.
All data captured is stored in a single system. Data can be displayed in real time on easy-to-read dashboards that can be viewed by study staff and sponsors. These dashboards also immediately alert the study staff to possible adverse events and lapses in compliance. Because all data is centralized and standardized, minimal data cleaning is needed at the end of a study, reducing the average time between LPO and database lock to 7 to 10 business days.
Meet our Team. See our Tech.
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