Why you need a remote-first CRO powered by purpose-built software to run efficient digital therapeutics (DTx) trials
As the digital therapeutics (DTx) space continues to expand, so does the demand for trial execution capabilities for complex DTx clinical studies. Having the right digital therapeutics CRO (DTx CRO) for a study can have a serious impact on the trial efficiency and regulatory success of the study.
The Decentralized Trials & Research Alliance (DTRA) defines a contract research organization (CRO) as “A company that provides support to the pharmaceutical, biotechnology, and medical device industries in the form of research services outsourced on a contract basis,” in their glossary. CRO services are technology-driven, and collaborative, and include the planning, coordination, execution, and supervision of clinical trials run in partnership with Curebase. As a modern, tech-powered trial management company, Curebase explicitly delivers on the execution of the trial as an all-in-one solution.
What is a digital therapeutics CRO?
A digital therapeutics CRO (DTx CRO), or contract research organization, is a company that provides a range of services to support the development and commercialization of digital therapeutics. This can include support with clinical trial design and execution, data analysis, regulatory compliance, and other aspects of product development. Digital therapeutics are software applications that are used as medical treatments, and a CRO can help companies navigate the complex process of bringing these products to market.
Designing executable digital therapeutics trials for success
Curebase’s all-in-one yet flexible approach to DTx clinical trials is purposefully designed to set studies up for success. Trials are designed and managed by clinical operations experts in decentralized research that can result in higher efficiency, cost savings, and more successful regulatory submissions. A key requirement of high-performing digital therapeutics CRO is delivering on the promises of these digital therapeutics by coupling technology and services to expand access to these types of studies at scalable cost.
Curebase’s cutting-edge, all-in-one software unifies your tech stack reducing the number of platforms utilized by teams, and streamlining operational efficiency. This means that Curebase can run a DTx study from start to finish in a decentralized manner that allows sponsors to collect the exact data they need. Our Curebase team aids sponsors in designing protocols that are optimized for decentralized research from the very beginning. This capability is crucial for bringing DTx products, and an essential tool for any digital therapeutics CRO, to market because sponsors can collect study data from patients using the digital therapy in a real-world setting, which is increasingly important for regulatory approval.
Digital therapeutics CRO’s success depends on having the ability to run a DTx study with remote components made possible with a fit-for-purpose technology platform that encompasses the capabilities necessary to execute on all remote or decentralized components. Not only will remote components to a trial render more accurate real-world data for digital therapy effectiveness, but it also allows sponsors to increase patient access, resulting in participant pools that are more diverse and representative of the patient populations they are trying to serve.
Having a modern digital therapeutics CRO partner that can help sponsors design, execute, and oversee a recruitment strategy specifically designed to address the needs of an individual digital therapeutic study can result in more efficient enrollment, and diversity. By activating virtual sites or local care facilities, prescreening and screening stages can be expedited to ensure optimized enrollment rates. While concurrently opening the digital therapeutics space up to a more diverse and geographically spread population.
Digital therapeutics CRO ensures patient engagement and recruitment in the desired care setting
A platform built around patient and provider experience that can flexibly be fit for purpose is important for any digital therapeutic study. Decentralized trial technology accelerates patient recruitment, improves retention, and allows you to reach the right patients at the right time. Particularly when it comes to monitoring patients using digital therapies in at-home or remote settings, patient retention and engagement is crucial.
A digital therapeutics CRO with strong and substantial experience in patient monitoring will be able to adapt and allow sponsors to deliver their digital therapeutic in the setting necessary for their study without compromising patient engagement or retention.
Curebase has experience employing innovative and validated patient engagement tactics for digital therapeutic trials - including patient-friendly workflows that instructed patients on each step of the study and what to expect next. Furthermore, digital therapeutic trials managed by Curebase have seen up to 89% patient retention throughout the entirety of the study.
Digital therapeutics CROs with the right experience
Having the right kind of digital therapeutics CRO experience is important s when it comes to running a DTx study. Having an all-in-one approach with direct, relevant experience and purpose-built technology can make a significant impact on the success of a digital therapeutic study. However, digital therapeutics CROs need to have the experience to prove their methods and strategies work.
Curebase has the most digital therapeutics IRB submissions, data delivery, and database work for FDA submissions of any DCT provider or digital therapeutics CRO, backing its all-in-one yet flexible approach to designing its clinical trial. Curebase is the industry leader in managing DTx trials with over 11 digital therapeutics trials executed across 11 indications and 2,000+ patients enrolled in digital therapeutics studies to date. These statistics help inform sponsors that when it comes to offering end-to-end services for digital therapeutic trials, Curebase has a proven success rate with methods flexible enough to cater to individual digital therapeutics studies' needs.