Decentralized Clinical Trials Consulting

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FDA Issues Final Guidance on DCTs and Decentralized Elements

Managing technological hurdles in decentralized clinical trials

Wearable technologies — including vital signs monitoring devices, smart watches, sleep rings, and a variety of emerging fitness and health devices — offer transformative opportunities for pharmaceutical companies, medical device makers, and other sponsors of decentralized clinical trials. By leveraging digital health tools for remote monitoring and real-time data collection, study sponsors can increase the diversity of enrolled patients, which is critical for regulatory acceptance, while gaining new insights into their health during large-scale clinical research.

For trial sponsors, device manufacturers, and others driving the evolution of digital health technologies deployed in DCTs, challenges abound. Concerns over data privacy and security for protected health information (PHI), data precision and accuracy, analytical and clinical validation, and more all raise questions as to whether algorithms and devices are fit-for-purpose to the rigorous standards of clinical trials, with regulations that differ by region and country across the globe.

How can Exponent help your organization address the challenges of deploying digital tools in DCTs?

Exponent's health and data scientists, AI/ML experts, and biomechanical and biomedical engineers help trial sponsors, manufacturers of DHTs, and other industry stakeholders navigate the transition from in-clinic investigations to remote monitoring. With extensive industry-leading experience refining and validating clinical tools, conducting rigorous fit-for-purpose evaluations, identifying and collecting real-world evidence (RWE), managing complex regulatory environments, and addressing usability, feasibility, and deployment issues, our multidisciplinary consultants offer clients end-to-end scientific and engineering support for complex decentralized clinical trials — from strategy to implementation — and specialized support for every stage in between.

Capabilities

With multidisciplinary backgrounds and decades of experience, Exponent consultants deliver evidence-based insights and end-to-end support for decentralized clinical trials and life science applications.

Exponent's analytical and clinical validation services enable clients to validate the quality, accuracy, and reliability of data representing health endpoints and outcomes of interest in decentralized clinical trials. Through our bespoke analytical validation services — including benchtop in vitro testing and in vivo validation with healthy human subjects — our data scientists, health scientists, biomechanists, and biomedical engineers evaluate the accuracy of wearable devices, medical technologies, and the complex algorithms they rely on. We help determine whether these devices are measuring what they're intended to measure in remote environments — whether that's steps per day, hours slept, heart rate, and more — all with the specificity necessary to support clinical findings.
Our multidisciplinary scientists and engineers apply the same rigorous approach to the clinical validation of these technologies and the data they produce to confirm that these measurements are accurate in relevant patient populations of interest for a remote context of use. With our state-of-the-art facilities, we can act as a specialized contract research organization (CRO) for digital tools and can partner with traditional CROs for larger-scale engagements.
Our digital health consultants work with pharmaceutical companies, CROs, and digital device makers to validate digital health technologies (DHTs) as "fit-for-purpose" for their decentralized clinical trials — in other words, that they work as intended for their specific clinical applications and the research goals of the trial.
Our data scientists, human behavior experts, UX consultants, and human factors team evaluate wearables and other medical devices to determine whether they can be used effectively in real-world clinical settings, identifying potential risks associated with device design, interface, and practical use. Our data science and regulatory compliance specialists further evaluate technologies used in clinical investigations as to the provenance of their data — supporting the privacy, security, and integrity of personal health data in accordance with global standards, such as the Health Insurance Portability and Accountability Act (HIPAA), the Food and Drug Administration's Code of Federal Regulations (CFR), Part 11, the EU's General Data Protection Regulation (GDPR), and international good clinical practice (GCP) guidelines.
Exponent's multidisciplinary consultants work with medical directors, clinical operations, data management, CROs, and other clinical stakeholders to implement the selected digital health technologies within complex decentralized clinical trials across varying demographics and regions, including the U.S., Europe, and Asia.
Through careful evaluation of the selected clinical trial technologies and multi-site deployment logistics — including localized tech support, scaling within clinical patient populations, and differing medical device and PHI-related regulations from country to country — our teams support a seamless transition from concept to protocol development to execution, domestically or internationally. With facilities and personnel across regions around the globe and partnerships with key CROs, our consultants provide clients with bespoke operationalization strategies and the ability to test those strategies before deploying full-scale, multi-country decentralized trials.

What Can We Help You Solve?

Our multidisciplinary consultants help pharmaceutical firms, device makers, and other trial sponsors navigate technological deployment for decentralized clinical studies across the globe. Our teams of biomechanists, data and health scientists, regulatory experts, and biomedical engineers offer clients end-to-end guidance and unmatched insights for the application of digital tools in remote clinical research.