ClinOne: Transparent Clinical Trial Execution

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ClinOne: Transparent Clinical Trial Execution

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Rob Bohacs, Co-Founder & CEO and Eric Schraufnagel, Co-Founder & CTO, ClinOneRob Bohacs, Co-Founder & CEO and Eric Schraufnagel, Co-Founder & CTO “Will this treatment work? Will it work better than other treatments? Will it have a side effect? Why should anyone try something that researchers are not sure will work?” As transparency has become the new modus operandi for pharmaceutical clinical trials, the shortcomings associated with these revamped paradigms becomes imperative. Amidst the increased complexity of the study’s scope and eligibility requirements, clinical trial management needs to be reinvented by improving the engagement between drug developers, clinicians and academic researchers, and patients. Better patient engagement and awareness not only helps in establishing drug efficacy and safety, but more importantly, it improves the health and quality of life for the patients and their families. With 3,000 active clinical trials in about 65 countries, ClinOne is a company that is disrupting the clinical trial management landscape with its suite of products developed to improve clinical trial enrollment, retention, and research site compliance. Built on the idea of enhancing patient experiences, ClinOne accelerates clinical trials through a unified clinical trial operating system for sponsors, research sites, and patients.

"The better our technology is, the more successful a patient’s experience is during his clinical trial"

Today with the help of eClinical technologies, it is possible to replace a clinical site with a virtual site to recruit patients and connect them with the investigator throughout study conduct. The integration of eClinical technologies with customer’s devices allows for clearer communication channels, improved diagnostics, more attentive treatment planning and administration, and automated data transfer throughout the study. In the age of eClinical trials where the increase in regulatory scrutiny creates additional challenges to the pre-existing difficulties of research institutions commercializing drugs, the informed consent maintains its place as the keystone of clinical research ethics. To that end, organizations need innovative solutions that address the dynamic challenges of enabling the centralization, standardization, efficiency, and cost savings of drug development. ClinOne is at the forefront of shaping the industry with its clinical trial management solutions. The company enables simplified patient interaction within a clinical trial through its solutions designed for immediate visibility into mission-critical details, which are accessible via the web and mobile devices. “Our suite of products makes real-time information readily accessible while increasing the efficiency of the researchers’ workflow. We wanted to create a solution that supports not only the patients but also their entire family, which accounts for a patient- and family-centric ecosystem. Our goal is to make the clinical trial process seamless for patients and to ensure they are protected and well informed about the trials,” asserts Rob Bohacs, the co-founder and CEO of ClinOne.

Our Video e-Consent tool not only reduces costs for sponsors and CROs but also saves time

Making Knowledge the Base

In the early days of clinical trials, the biggest problem for patients was the lack of adequate understanding regarding the nature of clinical trials and few educational resources. With the briefing from the research site and whatever little information patients already have, patients had to relay all the details to their families, which often lead to communicating inaccurate information. To help patients learn about a specific clinical trial and to allow them to easily share details with family members, ClinOne provides patients with an online, ePortal knowledge base—the ClinTrialConnect—aimed to educate patients about clinical trials and their diseases.

ClinTrialConnect allows patients to invite family members to access the entirely customizable knowledge base, which provides a comprehensive introduction to clinical trials and offers a library of information about their disease state and the details of a specific clinical trial. As a patient-facing technology, it empowers patients to make a more informed decision about trial participation. Ultimately, ClinTrialConnect affords research sites with the ability to allocate more resources towards recruitment efforts and processes geared to increase patient retention. During the planned recruitment window, research sites are able to double the rate of patient enrollmentsdue to the time saved from ClinOne’s solutions, which address other inefficiencies. Also, ClinTrialConnect maintains a wide-ranging repository of documents for the patients, which includes the complete package of trial participation documentation, like copies of signed informed consents, lab results, safety updates, and general trial updates from sponsors. By accelerating the recruitment timeframe and increasing retention rates based on a more educated patient-population, the clinical budget will be reduced by 50%.

To make getting information more convenient and effortless, ClinOne has developed a mobile software application that improves communication among investigators and the research staff across large organizations. ClinOne offers an additional level of security for study participants and clinical trial sites in the mobile solution, by adding electronic consent capabilities to it. ClinOne’s eConsent improves not only clinical trial workflows for patient consent but also offers real-time compliance tracking for re-consents along with automated consent logs. Aimed at eliminating violations related to Information Assurance and Privacy (ICF) compliance, the system automatically generates consent notes and logs, mandated by the FDA for specific studies. It also automatically creates a detailed log to document all the patient activities during the informed consent process, like the time taken to complete the consent, notes of present attendees, and the questions asked by the patient; thus, removing the need to create notes-to-files and update-maintained logs manually.

Through a holistic central clinical trial operating system, ClinOne excels, simplifies and accelerates clinical trials and serves its three different customers simultaneously: the sponsors, research sites, and the patients.

Delivering the Experience

As a provider of mobile and web applications designed to enhance patient, caregiver, and site engagement, ClinOne stays ahead of the curve as a “durable differentiator” with its newest offering—Video eConsent.
ClinOne’s Video eConsent successfully addresses the key issues of customer engagement by combining video conferencing and e-signature into a single, simple-to-use technology and allowing all parties to actively participate in the video consent process, including the patient’s family. By offering entirely remote consenting capabilities in high-risk studies, research sites can use their resources in a more efficient manner, making it a cost-effective measure. Through a multi-lingual support system, researchers can invite preferred translation services providers to the video call. Whether it’s getting access to consent and re-consent video files for patients wishing to reflect upon their informed consent form or conducting effective virtual clinical trials, ClinOne’s Video eConsent is a state-of-the-art model. “Our Video eConsent tool not only reduces costs for sponsors and CROs but also saves time, significantly improving the informed consent process for patients and sites,” states Bohacs. He asserts that being a part of the extraordinary consenting process would have a profoundly positive impact on the patients and families understanding and outlook of the clinical trial.

For keeping the customers more involved in the process without letting the stress take over, ClinOne provides a unique and simple tool—The ClinOne Community-designed to allow clinical trial sponsors to securely communicate with a large audience associated with the trial. The trial community feature simplifies continuous site engagement by providing real-time push notifications, e-mail messages, and read confirmations, for critical study updates, cohort closures, clarifications, webinars, and weekly/ monthly updates.

The Burgeoning “Idea”

The company recently introduced a comprehensive patient self-dosing management module for study treatment compliance monitoring. In addition to web-based and mobile app notifications, to automated-patient text reminders and patient text response collection, the module offers options to set native languages, self-manage dosing timing, and provides access the dosing calendar and guidance messages. It offers automated weekly compliance reports to the research site coordinator for supporting and tracking the patients dosing requirements and helps to identify patients with a poor compliance report.

ClinOne also released its integrated electronic patient reported outcomes modules—ePROLite, allowing a patient to bring their own device (BYOD). Being an embedded module within the ClinTrialConnect module, ePRO Lite acts as a central connection between sponsors, research sites, and patients. The patients are provided with a set of therapeutically focused questionnaires upon arriving for their treatment and follow-up visits. The ePRO Lite monitors patients’ compliance and automatically notifies the research site members on non-adherence to the mandates. It also provides a digital copy of the questionnaires to EDC providers. Now, there is an improvement to better understand how the patients feel subjectively in clinical trials.

For making patients’ driving arrangements easy, ClinOne has integrated Uber into its technology to ease the travel burden placed on patients. The technology is seamlessly integrated into ClinOne’s Digital Concierge suite and allows patients to request Uber for hassle-free rides to their visits. Even the patient’s family and research coordinator can restassured that the patient is on their way to the study visit as an automatic email alert is sent when the patient has been picked up. In the coming year, ClinOne plans to complete its integration with more ride-sharing services, including Lyft, to help patients who do not have transportation services or are unable to drive due to their illness. “The better our technology is, the more successful a patient’s experience is during their clinical trial experience,” states Bohacs.
- Abhinav Sharma
    April 01, 2019
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ClinOne Medical-Grade Remote Monitoring Coupled with the BiolntelliSense FDA-Cleared BioSticker Device to Help Remote Patient Monitoring

An announcement has been addressed by ClinOne about its strategic collaboration with BioIntelliSense to continue a combined health monitoring and clinical intelligence with the ClinOne ClinTrialConnect patient portal platform.

FREMONT, CA: The addition of an effortless trial participant experience, the FDA-cleared BioSticker single-use device, enables a 30-day continuous vital sign monitoring. The CEO Rob Bohacs states, “With BioIntelliSense, we will be able to capture a wide array of medical-grade biosensor data and offer our enterprise clients a new standard for Remote Patient Monitoring (RPM), resulting in more efficient and scalable virtual clinical trials.”
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ClinOne: Using Mobile Technology to Improve Clinical Trial Self-Dosing Compliance

DENVER: The costs and timelines to conduct clinical trials continue to increase, as does study complexity. While much of the focus in clinical trials has been on improving data quality and overall study efficiency in order to address cost/timeline/complexity issues, less attention has been paid to the impact of patient non-compliance to drug treatment.

It's estimated that after just three months on trial, patient dose compliance drops to 75 percent and at 10 months, that compliance rate drops to 60 percent. Consider the implications of this non-compliance:

• In order to maintain the power of the study, more patients must be recruited

• This often requires opening additional sites

• Drug accountability at time of study close-out can prove to be more burdensome

• All of which mean extending the study timeline

• All of the above mean the study will cost significantly more to conduct

ClinOne has introduced Dose Manager, a cost-effective mobile solution to help address this problem. Utilizing simple text messaging, automated reminders are sent to patients (as well as caregivers, as needed) to encourage them to take their medication. Similarly, research sites receive alerts to signify the need for follow-up. Sponsors and CROs benefit from reports that are designed to highlight sites where non-compliance may be a concern, thus allowing for more focused monitoring visits.

"It's estimated that 91 percent of mobile users keep their phone within arm's reach 24/7, while 90 percent of all text messages are read within three minutes of receipt, so this is a highly effective means of engaging the patient and driving better dose compliance," says Rob Bohacs, ClinOne's founder and CEO.

ClinOne BYOD ePRO Significantly Reduces Patient Reported Questionnaire Costs

DENVER: There's been much discussion over the last several years regarding use of BYOD (Bring Your Own Device) ePRO in clinical trials. Adoption has been slow due to regulatory, security and technical concerns. Now that these concerns have largely been addressed sponsors and CRO's are taking the plunge.

They recognize that sponsors benefit from the use of BYOD ePRO because of the reduced cost over hardware derived ePRO solutions, as well as significantly reduce site burden of not having to deal with provisioned devices. Site staff also aren't tasked with providing training and supporting patients on the use of the device. For patients, they get to use the device they use every day, which drives much higher compliance, typically in the range of 90% or better versus 25% or less with paper.

ClinOne's BYOD ePRO can reduce PRO costs by as much as 75% over the cost of paper (mainly the hidden costs) and 65% or more over existing hardware-based providers. ClinOne's fully validated, regulatory compliant ePRO solution is part of the ClinTrialConnect suite of patient-facing technologies. Patients can access, complete, review and sign their diaries or questionnaires electronically utilizing DocuSign all through the ClinTrialConnect patient portal and exported to the sponsors EDC vendor of choice. Patients and sites also receive a completed PDF version of the signed questionnaire to add into their EHR solution.

The ClinTrialConnect patient portal can also support patient training on how to complete ePRO instruments. Documents and videos can be uploaded to ensure proper completion to help further enhance compliance.

As Rob Bohacs, CEO and co-founder says, "Utilizing ClinOne's ePRO solution for the appropriate trials can lead to significant cost-savings, particularly for those trials requiring routine diary entries (daily or weekly) over several months or years. We are also planning our wearable sensor integration in Q2, 2019, which will sponsor to correlate data between ePRO and live sensor data – an industry first."

ClinOne offers a complete suite of mobile and web applications to enhance patient, caregiver and site engagement. Currently, our solutions help support close to 3,000 clinical studies, across 1,900 research sites in over 50 countries. If you're interested in learning more or scheduling a demo, contact us. Visit for more information.

ClinOne Increases Mobile Security Through Biometric Authentication

DENVER: More than a billion plaintext passwords from third-party breaches are freely available over the internet. Let that sink in, especially if you are one of the 59% of users who still use the same password everywhere.

These numbers are particularly sobering when considered in the context of the highly regulated clinical research arena. As clinical research becomes more mobile, sponsors and CROs are being pressured to provide tighter security measures to protect against unauthorized access to clinical data.

Biometric authentication allows technology platforms to replace passwords with physical validation of who the person is by using identifiers such as a fingerprint or facial recognition. Currently, 62% of all companies use biometric authentication and an additional 24% plan to incorporate the technology in the next two years.

ClinOne now brings biometric authentication through fingerprint and facial recognition to its iOS and Android mobile applications. This provides a significant improvement in security over using a password, stopping instances where a password is borrowed, sold, or stolen.

Biometric authentication paired with ClinOne's two-factor authentication (2FA) drastically decreases the risk of a data breach. It also favorably adheres to data protection laws, such as HIPAA and the EU's GDPR.

"Passwords are no longer considered enough in protecting sensitive data within clinical research. ClinOne's biometric and multi-factor authentication capabilities significantly increase security and privacy controls around accessing clinical data in the virtual environment," says Eric Schraufnagel, CTO and co-founder of ClinOne.