Innovative CROs for Digital Therapeutics Clinical Trials In the U.S.

CROs for Digital Therapeutics Clinical Trials In the U.S.
CROs for Digital Therapeutics Clinical Trials In the U.S.

According to the Digital Therapeutics Alliance (DTA), digital therapeutics (DTx) deliver “evidence-based interventions driven by high-quality software programs to treat, manage, or prevent a disease or disorder.” DTx interventions are administered independently or with medications, devices, or other therapies. Intending to offer a combined product, some companies develop their DTx and medicine in parallel through digital therapeutics clinical trials, e.g., Orexo’s sublingual combination of buprenorphine/naloxone for opioid use disorder (OUD) and its digital web-based therapy for OUD. A DTx contract research organization (CRO) provides services to support the development and commercialization of DTx.

In 2022, the global DTx market revenue was US$4.5 billion, projected to grow at a compound annual growth rate (CAGR) of 31.6% to $17.7 billion in 2027. One of the leading market drivers is the need to control escalating healthcare costs. Applications of DTx in preventive health include prediabetes, obesity, nutrition, and lifestyle management, and treatment or care-related applications include diabetes, chronic respiratory disorders, medication adherence, substance use disorders (SUDs), and cardiovascular diseases. Prominent players in the U.S. DTx market include Noom, Inc., Omada Health, Inc., Pear Therapeutics, Inc., CogniFit, Inc., Akili, Inc., and Twill, Inc.

Challenges of Digital Therapeutics Clinical Trials

Digital therapeutics clinical trials often struggle to meet evidentiary standards. DTx products are assessed and cleared by regulatory bodies, e.g., the U.S. Food and Drug Administration (FDA), as required to support product claims regarding risk, efficacy, and intended use. The DTA published a document with foundational principles outlining the clinical evidence necessary for the appropriate and efficient assessment of DTx interventions.

Another common challenge with digital therapeutics clinical trials is trial design. Companies developing DTx products encounter the same challenges as those in drug discovery and development, including clinical trial patient recruitment and retention, data quality, timelines, and costs. In addition, there are technical security concerns related to all-digital therapeutic interventions. DTx differs from drugs because it requires no physical logistics, and its endpoints can be captured in the app itself, making it well-suited for decentralized clinical trials (DCT)—more on this below, as the featured CROs conduct DCTs.

In the U.S., only 19% of people with SUDs receive evidence-based treatment. Pear Therapeutics developed a prescription DTx, the only FDA-authorized therapy for patients with cocaine, cannabis, and stimulant use disorders. A recent study found that this DTx was associated with a statistically significant decrease in healthcare resource utilization and lower healthcare costs (cost reduction of US$3,591 per patient over six months).

Below we list the leading CROs working to help sponsors overcome the challenges of managing digital therapeutics clinical trials in the U.S.

Top 5 CROs for Digital Therapeutics Clinical Trials In the U.S.

A list of the five top contract research organizations leading digital therapeutics clinical trials in the U.S.


CMIC is the largest CRO in Japan and has had a presence in the U.S. since 2007. CMIC provides drug development and clinical site management services. CMIC has a global footprint with over 7,000 employees and a presence in the U.S. since 2007. Through its strategic partnership with SUSMED, Inc., CMIC provides DTx development services, including app development, testing of apps in clinical trials, and post-launch support. In 2020, CMIC launched a trial management system to address DTx clinical trial challenges, ensuring blinded assignment and preventing unauthorized access. Additionally, CMIC aimed to address the development challenges of security and cost. Having contributed to the digital transformation of the CRO industry through innovative solutions like DCTs and supporting DTx, CMIC was recognized by Frost & Sullivan in 2021 through its Best Practices Awards.

2. Curavit Clinical Research

Curavit is a full-service, virtual CRO prioritizing the design and execution of digital-first DCTs. Founded in 2020, Curavit leverages emerging technologies to recruit, engage, and monitor diverse patient populations. Curavit has a rigorous process to screen and educate potential participants, ensure they are aligned with the protocol, and that the data can be used for FDA approval. Through its approach, the company promise is improved timelines, reduced costs, generation of real-world data, and enhanced patient access to therapies. Curavit is experienced with DTx decentralized trials as more than half of its clients are DTx developers – DTx clients include Swing Therapeutics, Lark Health, Curio, and Sana. For Swing Therapeutics DTx digital symptom tracker for fibromyalgia, Curavit ran a single virtual site and demonstrated that it could enroll ten times more patients than all the traditional physical sites, which started simultaneously.

3. Curebase

Curebase, committed to democratizing access to clinical trials, offers an all-in-one approach to DTx clinical trials designed and managed by ClinOps experts in decentralized research. In January 2023, Curebase launched its all-in-one software and trial execution package aimed at helping DTx companies accelerate clinical trials. Using its software reduces the number of platforms teams utilize, thereby improving operational efficiency. Sponsors can collect data from participants using the DTx in a real-world setting, further strengthening their submission for regulatory approval. According to Curebase, it has the most DTx Institutional Review Board (IRB) submissions, data delivery, and database work for FDA submissions of any DCT provider or DTx CRO. Curebase has completed 17 DTx studies across multiple indications, with over 3,500 patients enrolled in DTx studies.

4. ObvioHealth

ObvioHealth is a virtual CRO launched in 2017, delivering the same services as a traditional CRO but in a decentralized environment; by conducting DCTs that provide therapeutic evidence. ObvioHealth has conducted DCTs in 35 countries across 12 therapeutic areas, with 88% retention and 92% ePRO compliance. In February 2023, ObvioHealth launched its proprietary application programming interface (API) designed specifically for DTx clinical trials. The API ensures tight integration between the DTx and ObvioHealth’s DCT platform to capture more accurate efficacy and adherence data to correlate efficacy with adherence to the DTx. This negates the need for separate apps that may ask participants the same questions, thereby reducing participant task duplication (and inconvenience) and the complexity of trial design for sponsors.

5. Vial

Vial was founded on a mission to reimagine clinical trials and deliver faster and more efficient trials. The Vial Technology Platform leverages connected systems and intuitive design to run global trials efficiently at scale. Vial’s eClinical Suite delivers high-quality data through connected data capture and review. Vial replaces paper source in trials — driving a significant change in trial workflows. Driven by process automatization, Vial’s Site Startup app enables lightning-fast onboarding. Sites can be activated in as few as 30 days. Vial’s Patient Recruitment Platform recruits patients across 15+ channels and converts them to randomizations — radically reducing enrollment periods. For more info, visit us at Vial Digital Therapeutic CRO.

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