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What a fit-for-purpose all-in-one digital therapeutics offering means for DTx trials

February 2, 2023

When running a clinical trial for a digital therapeutic, there are many considerations and options for software, CROs, locating sites, recruitment tactics, etc. Trying to find the right vendors to facilitate each study component only increases the complexity of trial execution. Launching a digital therapeutics study can be an intricate and time-consuming process, especially as new standards and guidances are consistently put forth by regulatory bodies. These considerations and decisions can elongate a DTx sponsor’s start-up time while complicating the design and execution of the study. 

A one-stop-shop solution for running digital therapeutics trials refers to a vendor's ability to offer any and all of the components needed to run a DTx trial from start to finish including study design, planning, and execution. With the right bundles of technology-driven services, an easy-to-use eClinical platform, flexible virtual site models, and more, these vendors are the only partner a  sponsor needs to run their trial with greater cost savings, efficiency, and collaboration.  

Flexible digital therapeutics site models: 

Sponsors can now run studies with technology that was designed and built for the purpose of executing digital therapeutics research. These types of eClinical platforms have workflows and tools developed specifically to support virtual and hybrid DTx trials that allow patients to participate in real-use settings. This technology enables flexible site model options, data-driven recruitment strategies, superior data capture capabilities, and quality remote patient monitoring while consolidating all real-time study data and patient metrics in one dashboard. 

Technology-driven services: 

A vendor with an all-in-one digital therapeutics offering has in-house clinical research coordinators (CRCs) trained to manage patients in DTx studies, principal investigators (PIs) with deep experience running successful digital therapeutics trials. These experts are also robustly familiar with the eClinical platform, patient experience journey, and recruitment tactics to ensure seamless cooperation among all study components. 

Trial management services, such as Institutional Review Board (IRB) submissions, project management, digital therapeutics CRO services, data management, patient recruitment, and more enable trial vendors to take a trial from start to finish. These comprehensive, flexible capabilities and services make it easy for DTx sponsors to find the exact tools they need to run their trial with just one partner. 

Not only does an all-in-one digital therapeutics offering accelerate the enrollment process, but it also allows DTx trial sponsors to scale studies to include more diverse groups of participants that better represent the greater patient population, leading to more effective digital therapeutics.

This type of all-in-one digital therapeutics offering streamlines vendor selection and trial execution for DTx companies. This translates to faster, more efficient studies and more treatments in the hands of patients sooner. 

Curebase has extensive experience in digital therapeutics, enrolling over 3,500 patients in over 17  DTx studies across several indications including depression, anxiety, gastrointestinal problems, cancer, heart issues, rare diseases, and more. Learn more here about Curebase's all-in-one digital therapeutics offering. 

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