EU Regulatory Expertise. GDPR Compliance. Multinational Capabilities
Decentralized clinical trials are transforming the clinical research industry. But, with change comes new questions and uncertainties for trial sponsors like you—especially in Europe, where regulatory bodies differ on acceptance. ObvioHealth has successfully conducted DCTs in many EU countries. Let us equip you with answers so you can make smart decisions about your trial design.
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European Clinical Trial Specialists
EU Regulatory Expertise
GDPR Compliant
Multinational Capabilities
EU Regulatory Expertise
Deciding which elements should be virtual and which should remain traditional depends on your study endpoints and the local regulatory bodies. Our goal is to help you identify touchpoints that can be enhanced with decentralized solutions. We work with our sponsors to begin discussions with ethics committees early in the study design process.
GDPR Compliant
Your DCT partner must protect patient data. Not only is ObvioHealth GDPR compliant, but our platform has also been developed to meet the security controls and requirements of the most demanding pharmaceutical clients.
Our tech security team has completed thorough new vendor audits for several of our multinational clients. We also took part in a comprehensive due diligence process with IQVIA prior to our partnership.
Multinational Capabilities
We have worked with ethics committees to design studies in a multitude of European countries, including those highlighted in the image to the right. We also translate all study materials into the regions' native languages to ensure participant ease, understanding, and compliance.
eConsent
eSignature
ePRO
IP Supply
Telemedicine
Wearables
Home Nursing
Home Sampling
AU
BE
BR
CA
CN
FR
DE
IL
IT
IN
PL
RU
KR
ES
GB
Stats Don’t Lie
Our Tech & Team drive higher retention, compliance, and adherence rates for trials that are more likely to be completed on time and on budget.
Percent Retention Rate
Percent of participants enrolled in an ObvioHealth trial who complete the study
ePRO Compliance
Percentage average of ePRO compliance in completed ObvioHealth 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 app walks patients through the clinical trial process step by step. From enrollment and eConsent to patient training and study questionnaires, our user experience makes participation easy. 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.
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.
Once all the data has been captured, ObvioHealth’s end-to-end capabilities store everything in a single system. Data is displayed in real time on easy-to-read dashboards that can be viewed by the study staff and the sponsor. These dashboards also immediately alert the study staff to possible adverse events and lapses in compliance. 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.
At ObvioHealth, we believe experience is key. We have developed and validated 250 ePRO/PRO solutions across various therapeutic areas, leading to successful outcomes and endpoints.
Since the start, 7 of our 21 clients have given us repeat business—the greatest proof of satisfaction.
ObvioHealth is truly a global organization. We have run trials in 28 countries across 5 continents.
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.
ObvioHealth is IQVIA’s strategic partner, collaborating on consumer health projects to deliver virtual real-world studies.
The partnership unites ObvioHealth’s DCT platform with Dedalus’s EHR software solutions, providing meta-data insights from patient records for prognostic and predictive analysis. This results in better study designs and more precise recruitment.
European-Centered Case Studies
Objective
A Phase III study to evaluate the safety of an oral contraceptive in adolescents.
Methodology
This study amalgamates the unique challenges associated with both women’s health and pediatric therapeutic areas. To ensure success and safety, ObvioHealth designed this study using hybrid modules to include site visits as well as the collection of ePRO—using the ObvioHealth app—to monitor patients in between visits.
Due to the number of questionnaires required for this study, ObvioHealth needed to design its ePRO instruments to be as intuitive as possible for patients. An easy user-experience, as well as push notifications to remind patients to complete questionnaires, will help to facilitate compliance. eDiaries will record numerous data points, including task completion and the overall well-being of the patients.
Participant safety—which is paramount in this pediatric study—is evaluated via the analyzation of laboratory and examination findings, as well as remote data monitoring of ePRO collected between site visits.
The Results
This study is ongoing, with nearly half of the patients already enrolled.
Objective
A multi-national pharmaceutical company required clinical data to validate the safety and performance of five of its nasal spray allergy products post CE-mark, in accordance with MDR 2017/745 Annex XIV Part B.
Methodology
ObvioHealth designed and conducted all five of these post-market clinical follow-up studies, which were successfully executed in multiple countries across Europe. All study materials were translated into the primary languages spoken in each study’s location.
Digital recruitment for all five studies was designed to target a population that had used the nasal spray products in the past six months.
Each study called for participants to complete questionnaires, which were designed to be simple and intuitive to keep compliance rates high. This also allowed for participants to report any adverse events or side effects experienced from using the product.
The Results
Recruitment goals for each of these studies were met far earlier than projected, with LPO dates occurring an average of 64 days ahead of those originally proposed. As a result, the studies reached completion before their targeted end dates, meeting an average duration of 48 days.
The sponsor was able to gain valuable insights into participant use and satisfaction with the product.
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 PFM 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 (Clinial Operations And Coordination Hub) team.
There were no required office visits in this study. Upon randomization, subjects receiveed three scheduled phone calls from the COACH team for education on PFMT exercises. For the remainder of the study, patients receiveed additional phone calls regarding the treatment plan and safety monitoring.
The 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 an 95% ePRO compliance rate.
The study delivered statistically significant results for the device vs control Kegel groups for both of 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
