Digital Therapeutics (DTx)
Advancing Clinical Research Through Digital Therapeutics
Digital therapeutics are changing how evidence-based interventions are delivered and experienced by patients. As software-based therapies become an increasingly important part of healthcare, DTx developers need fit-for-purpose research approaches that account for the unique combination of therapeutic intervention, software, patient experience, and continuous product evolution.
THREAD partners with digital therapeutics developers to design and execute studies that generate high-quality evidence across the product lifecycle—from early validation and pivotal trials to post-market and real-world evidence studies.
A Platform Engineered for DTx Clinical Research
THREAD's configurable clinical research platform supports the unique requirements of digital therapeutic studies across decentralized, hybrid, and site-based research models. The platform can seamlessly integrate with digital therapeutic systems and other technologies to bring product usage, engagement, patient-reported outcomes, clinician assessments, digital endpoints, connected device data, and other study measures into a unified research experience.
With flexible APIs and integrations, THREAD enables data to flow between the clinical research platform and DTx systems while supporting capabilities such as eConsent, eCOA and eDiaries, telehealth, eSource, participant engagement, and real-time analytics. This connected approach helps research teams reduce technology fragmentation, streamline data collection, and generate the clinical and digital evidence needed to evaluate safety, efficacy, engagement, adherence, and patient outcomes.
Consulting Services Designed for DTx Evidence Generation
THREAD's consulting team helps DTx developers build fit-for-purpose evidence strategies aligned with regulatory, clinical, and market access objectives. Our experts can support study design, endpoint and outcome selection, technology integration, and the incorporation of product-generated data into clinical research.
From early feasibility and validation through pivotal trials and post-market real-world evidence generation, THREAD combines scientific, operational, and technology expertise to help DTx developers demonstrate how their therapies perform in clinical studies and real-world settings.
