While these sites are important for clinical research, they make patient recruitment challenging. Many participants are forced to travel to these locations for recurring visits, and many face obstacles, such as taking time off work, childcare, or living in remote locations.
With the rise of technology (and AI), decentralized clinical trials are becoming more popular where some or all of the activities required in clinical trials take place in other locations– such as patients’ homes or community centers– rather than actual clinical trial sites.
Different technologies support decentralized clinical trials while retaining patient-centricity and safety, such as remote patient monitoring, digital consent forms, telemedicine, electronic clinical outcome assessments (eCOAs), electronic patient-reported outcomes (ePROs), and mobile data collection.
Large companies like IQVIA, Parexel, Oracle Health, and Syneos Health provide essential solutions for decentralized clinical trials, enabling trials to take place outside of traditional clinical settings and allowing trials to be conducted in more patient-friendly environments, broadening access to more diverse patient populations, accelerating timelines, ensuring that clinical trials can adapt to the evolving healthcare landscape.
Below is a list of US-based companies focusing on the improvement of decentralized clinical trials. The companies are listed in alphabetical order.
Allucent
Headquarters: Cary, North Carolina
Founded: 2014
Allucent is a clinical research organization (CRO) with a strong focus on decentralized clinical trials. The company’s Patient Direct Trials platform is a customized all-in-one decentralized trial solution, including eCOAs, ePROs, telehealth, site workflows, analytics, and dashboards, integrations for sensors and wearables, eConsent forms to reduce human error and site burden, patient notifications and reminders, home health and concierge services, as well as delivery of investigational medicinal products (IMP), test kits, and other clinical supplies.
The company’s patient-centered trial models help streamline the clinical trial process, improve participant access and reduce patient burden, enhance trial efficiency, and accelerate timelines for sponsors seeking regulatory approval.
Curavit Clinical Research
Headquarters: Boston, Massachusetts
Founded: 2020
Specializing in decentralized clinical trials, the virtual CRO Curavit Clinical Research has developed a decentralized clinical trials platform called Stratus, which uses technologies such as cloud computing, data science, and digital health to engage and monitor diverse patient populations with the aim of reducing costs, improving trial timelines, and enhancing patient access to treatments.
In February 2024, the company completed a virtual clinical trial for the Sana Device, an investigational wearable device that offers anxiety relief immediately and is used to treat symptoms of post-traumatic stress disorder (PTSD), which is developed by Sana.
EmVenio, a PCM Trials Company
Headquarters: Durham, North Carolina
Founded: 2020
EmVenio Research focuses on advancing decentralized clinical trials by providing mobile clinical research units. These allow patients to participate in trials from more convenient locations outside of traditional healthcare settings, for example, from home or community-based sites. This approach increases patient access, inclusivity, and diversity in clinical trials and helps accelerate research timelines.
EmVenio was acquired by PCM Trials in February 2024 to create a more patient-centric model for hybrid and decentralized clinical trials.
ObvioHealth
Headquarters: New York City, New York
Founded: 2017
ObvioHealth is a digital health company specializing in decentralized clinical trials. The company has developed different end-to-end solutions that allow trials to be conducted remotely through a patient-centric approach. The company works closely with trial sponsors to include and strategize technology in clinical trial design, reducing the burden on patients, while still delivering relevant data.
The ObvioGo platform and mobile app enable remote data collection through the participants’ own smartphones and integrate seamlessly with most wearable devices for remote patient monitoring.
PPD
Headquarters: Wilmington, North Carolina
Founded: 1985
Acquired by Thermo Fisher Scientific in April 2021, PPD is a global CRO providing several services for decentralized clinical trials and leveraging digital tools, remote monitoring, and patient-centered solutions to conduct trials outside traditional clinical settings.
The company’s decentralized clinical trial services include telemedicine, home health care and nursing, eConsent, eCOAs, ePROs, and the integration of wearable and other devices– such as sports- or smartwatches, tablets, smartphones, and monitors– enabling real-time data capture. This increases patient participation and access, as well as streamlined trial processes, trial flexibility, faster timelines, and improved data quality for the trial sponsors.
Science 37
Headquarters: Morrisville, North Carolina
Founded: 2014
Science 37 is a leader in decentralized clinical trials providing virtual site and patient recruitment solutions that make participation more accessible and convenient for patients, while including more diverse patient populations and involving people beyond the reach of traditional sites.
The company offers digital tools like eConsent, telemedicine visits, remote monitoring, and direct data capture, so clinical trials can occur in patients’ homes or other non-traditional settings. Science 37’s approach accelerates recruitment, improves patient population diversity, enhances data quality, and retains patients by 96%, compared to traditional, site-based trials that retain 70% of patients.
Science 37 was acquired by the telehealth and diagnostics company eMed for $38 million in January 2024.
Vivalink
Headquarters: Campbell, California
Founded: 2014
Vivalink supports decentralized clinical trials by specializing in remote patient monitoring solutions. The company has developed regulatory-cleared wearable sensors and remote biometric monitoring devices that collect real-time human vitals and other physiological parameters, including body temperature, heart rate, respiratory rate, blood pressure, step count, glucose levels, and weight, all of which are important for clinical studies.
These devices allow for continuous patient monitoring and provide accurate data for decentralized or hybrid clinical trials without the need for patients to visit clinical sites. The company’s solutions are integrated with cloud access, so multiple sites can seamlessly collaborate.
In April 2024, Vivallink announced that it would be collaborating with the Rett Syndrome Research Trust to support the VIBRANT study with its heart rate- and oxygen saturation-monitoring wearables.
