Our research institutions currently manage 40 to 500 clinical trials sponsored by a broad range of sponsors. Together, these trials require the management of thousands of patient appoints and protocol adherence to be successful.
Until now, these institutions were responsible for every aspect of each trial without a central system to manage appointments, trial workflows and communications. The administrative burden was immense, due to the inefficient process and inadequate means to engage and retain patients – not to mention the risk of errors. Today, ClinOne is actively managing 2,580 active clinical trials across 53 countries.
“ClinOne serves as the optimal tool to provide the right content to principal investigators, sub investigators, and research teams 24-7 on their mobile devices,” says Rob Bohacs, CEO of ClinOne. “Distributed access to clinical trial information and workflow tools are an absolute must given the size of many research institutions, ranging from a few city blocks to a dozen square miles.”
For patients who enroll in clinical trials, the experience can be daunting. They’re required to stay on top of multiple appointments and other details related to the trial with minimal communication and support. Bohacs witnessed first hand the patient side of the trial experience prior to his father losing his battle with ALS early in 2018.
“I’ve been in clinical research for 12 years and the last two years provided the greatest clarity of the patient-related challenges,” he says. “The patients should be the center of the clinical trial, but they are a secondary consideration. Research institutions and sponsors have just begun to realize that once a patient agrees to participate in a trial, they must have a seamless experience that not only empowers the patient but also manages their complex schedule and participation requirements.”
Regardless of the excellent care his father received at the research site, Bohacs sought the best support for his father. His quest led him to create ClinOne to deliver an all-around optimization of the clinical trial process with a patient- and family-centric solution.
"Our technology focus will continue to be on streamlining clinical trial processes to bring therapeutic drugs to market faster"
“Working with these institutions helped me understand what patients and their families need and what we can do to build our technology to address and solve their major pain points,” Bohacs says.
Bohacs compares ClinOne to an “Expedia” designed for clinical trials. The idea behind the solution was to make real time information readily accessible and to increase the efficiency of the researchers’ workflow with the goal of enhancing the patient experience. If it’s too difficult for a patient to find and participate in a trial, no one benefits.
Patient recruitment and patient retention are two of the leading reasons why clinical trials take longer and drive budget overruns of up to 50 percent. ClinOne enables research sites to double patient recruitment during the planned recruitment window.
ClinOne is the perfect tool to deliver the required content to research teams 24X7 via their web and mobile devices
“When patients miss an appointment, it triggers a protocol deviation which can potentially cause a regulatory infraction for the research site. This risks the clinical data and also the patient’s treatment and health,” Bohacs says.
Part of the ClinOne solution includes a dynamic digital concierge service that guides patients through various steps and complexities of their clinical trials.
ClinTrialConnect: Patient-Facing Technology
In the past, patients participating in clinical trials rarely had the opportunity to gather enough information about their trial. Patients were briefed about the trial by the research site and then they had to communicate all the details to their families, often leading to misinformation. Families are vital stakeholders in trial participation decisions—both initially and throughout the trial process.
Through ClinTrialConnect, ClinOne links all research patients with an e-Portal knowledge base, which enables patients and their designated family members to access a library of information about their disease state, clinical trials in general, and the details of a specific clinical trial. This helps empower the patient to make an informed decision about trial participation.
In addition, ClinTrialConnect maintains a comprehensive repository of trial documents for the patients. This repository includes the complete package of trial participation documentation, the patient’s informed consents, lab results, safety updates and general trial updates from the sponsors.
The ClinTrialConnect digital concierge integrates with Google Maps to support the management of the myriad of patient appointments. The digital concierge also forwards appointment expectations, alerts, and reminders for the next appointment in up to 30 different languages. Researchers can also securely deliver updates and critical information to patients participating in a trial that is HIPAA-compliant private, confidential, and encrypted.
Features benefiting referring Providers, trial sites
ClinOne has added a number of features to help referring providers receive information about available trials and to make trials more manageable for the sites.
“A significant feature of the ClinOne technology is to connect referring physicians to studies that are being conducted to recruiting research sites located nearby. The system pushes periodic updates to referral providers to create awareness of local clinical trials. This module provides real-time contact information of the trial coordinator to make the referral process seamless and efficient. In addition, ClinOne workflow makes screening the patient at the point-of-care quick and easy,” cites Bohacs.
The ClinOne solution provides trial binder information in both mobile and web environments. The digital trial binder presents the correct version of the protocol to the user. For instance, when a physician has to make a critical decision based on the information contained within a 100-500 page protocol, the ClinOne platform ensures that the information is provided to research teams in a mobile and easy-to-read format. The ClinOne digital platform includes a contacts feature that provides a real-time directory of trial personnel, vendors, and other site users; research site personnel can quickly reach the appropriate trial monitor in the event an emergency medical conditions arise.
Making the most of modern-day connectivity, trial sponsors have enthusiastically adopted the use of video content. The ClinOne video delivery module enables sponsors to provide video updates, recorded investigator meetings, CEO messages, training videos, and visual guidance for complex procedures.
“Sponsors can share these informative videos with clinical researchers globally; all of the research sites can then follow the procedure as it was designed,” Bohacs says.
The ClinOne Community is a unique and simple tool that’s designed to allow clinical trial sponsors to securely communicate with a large audience that is associated with the trial. The trial community feature simplifies continuous site engagement including trial updates, cohort updates, clarifications, webinars and weekly/monthly updates. This feature provides real-time push notifications, e-mail messaging, and read confirmations.
Upcoming Plans and New Features
Later this year, ClinOne will release a consent management module to maintain up-to-date consents, which is a critical part of regulatory compliance. In addition, the solution creates a log file to support FDA research site audits and automatically populates the research sites’ communications logs, thus removing the need to create notes-to-files and updating manually maintained logs.
Electronic health record integration
“One of the significant integrations that we are planning is to sync our solution with an electronic health record (EHR),” Bohacs says.
With EHR data combined with a series of algorithms and analytics, ClinOne plans to identify patients who meet the criteria for clinical trials and provide a quick, simple workflow for practitioners and investigators to communicate with patients about particular clinical trials. With this addition, the company will be able to leverage the convergence of clinical trial inclusion/exclusion criteria and the patient’s health records.