Rob Bohacs, CEO, ClinOne
Clinical Research relies heavily on successful patient enrollment and on-going patient engagement to achieve the study aims, and reached the ever-important study timelines. Traditionally, clinical research efforts have taken years to move the project needle from a scientific idea, through the research activities, to the final approval and marketed clinically. However, the COVID-19 pandemic is changing the research landscape. Today, the quest to swiftly develop effective treatment therapies and vaccines for COVID-19 drives pharmaceutical companies to seek options that can dramatically reduce the conventional decade-long process down to a mere matter of months. Once pharmaceutical companies receive notice from FDA, EMA, and other regulatory agencies, they may move forward with their studies. They must determine which sites have suitable patient populations to meet the strict inclusion and exclusion criteria defined in clinical research protocols. Colorado-based ClinOne, Inc. and its clinical research portfolio of trial enrollment and patient engagement solutions aid drug developers, institutional researchers, and site users to enhance their operational efficiencies in today’s pandemic world. “With our software, we assist clients in making well-informed, data-driven decisions concerning patient engagement while meeting the specific regulatory requirements for the continuation of their clinical trials,” says Rob Bohacs, CEO at ClinOne, Inc.
Discussing the various capabilities of the ClinOne solutions, Bohacs highlights the eConsent module, allowing researchers to deliver and obtain informed consent for clinical trial participation from patients remotely or on-site, depending on the availability and location of the necessary attendees. Additionally, this module connects patients with principal investigators (PI) through a video interface “to review critical information to their patients and allow for thoughtful discussion regarding study participation and on-going efforts until their final visits,” adds Bohacs.
At the same time, ClinOne offers a central dashboard to PIs and research site users, which facilitates the seamless and efficient scheduling of upcoming tasks and events, and enhance HIPAA compliant communication with their patients while measuring patient engagement and overall study compliance. Above all, the company has developed a technology platform with multiple value-added modules that simplifies the PIs and research staff members’ responsibilities and enhances the patients' trial journeys with its highly engaging interface.
The company’s portfolio has an open architecture to make it easier for clients to integrate their own devices with ClinOne’s software while eliminating additional proprietary products. “Our software can integrate with any cloud-based, web-enabled mobile device or desktop and send real-time updates on the latest trial developments to site users and patients alike," states Bohacs. Apart from its software, ClinOne also provides consultation and support services to clients using its software portfolio.
ClinOne is currently working with over 40 pharmaceutical companies and 2,000 healthcare institutions across 55 countries worldwide with such unparalleled capabilities. In one instance, the company assisted a biopharmaceutical company in completing its phase III clinical trial objectives. Initially, the client had patients in multiple locations worldwide and could not maintain active patient engagement, significantly impacting the trial's timelines. ClinOne was brought in and actively engaged the patients, leveraged its dosing management tool, and sent regulatory submissions to the concerned entities within eight weeks. Thus, the trial was invigorated, the client attained its phase III objectives, and the successful commercialization of its product occurred. “We achieved success in this engagement because of the flexibility and scalability nature of our software, which allowed us to align our software functionalities to meet the needs of the client," mentions Bohacs.
Today, ClinOne has offices in London, Boston, Philadelphia, and Denver, with plans to expand its footprint to newer geographies. Looking ahead, the company is collaborating with BioIntelliSense—a developer of wearable body sensors to track patients' vital signs and other critical health indicators and CQuentia for FDA approved COVID-19 testing and surveillance. In conclusion, Bohacs says, “We do not want to expand our portfolio with meaningless added features; but, develop functionalities that add real value and allow us to become a central supporting mechanism for all patient-focused actions trials.”