Decentralized Clinical Trials: Partnering to Reduce Risk

Contract research organizations (CROs) and pharmaceutical companies are looking to drive innovation and decentralize clinical drug trial operations through Internet of Things (IoT) technology more than ever. Decentralized clinical trials, powered by connected devices, patient monitoring tools, and eDiary software, offer myriad benefits including simplified patient experience, improved quality of care, increased patient retention, and more accurate data. This results in a positive impact on patient outcomes and ultimately faster time-to-market for critical new drugs. 

With its many quantifiable benefits, it’s no surprise that more clinical drug trial companies than ever are looking to leverage IoT technology to decentralize their clinical trials. However, many companies find that when they attempt to adopt new technology with in-house resources, their projects end up costing more in the long run and often fall short of meeting expectations. In fact, 76 percent of all IoT projects fail according to a 2017 Cisco survey, resulting in further delays and rising costs. 

It makes sense when you consider all of the services a CRO provides to pharmaceutical companies—project management, clinical trial data management, medicine and disease coding, quality and metric reporting, statistical analysis, validation programming, safety and efficacy summaries—that the complexity of deploying IoT projects falls outside of their range of expertise. That’s exactly why CROs rely on experts in IoT and connected healthcare to streamline the process of connecting and managing devices. 

There’s a lot to think about when looking at connecting and managing devices for decentralized clinical trials, including how to handle things like supply chain management, hardware sourcing and procurement, mobile device management, wireless connectivity, network management, configuration, kitting and shipping, reverse logistics, regulatory compliance, and more. Having an IoT enabler as a technology partner means simplifying the entire process and trusting an expert to handle the entire device lifecycle.

Not all IoT service providers are created equal, so it’s important to select a highly compliant partner who is familiar with the unique needs of decentralized clinical trials in order to accelerate, deliver, and scale IoT applications. 

KORE has tailored a managed services suite designed to make developing and maintaining IoT life sciences solutions easier than ever. Our suite includes end-to-end project management, consulting, and comprehensive Mobile Device Management (MDM) – specifically built to meet the unique patient privacy and security requirements of the healthcare industry. 

Quality management is at the core of KORE operations. Actively maintaining ISO 13485 and 9001 certifications and FDA packaging registrations, KORE holds years of expertise with the design, development, production, and distribution of medical devices. KORE frequently meets and complies with HIPAA requirements for many leading healthcare and life sciences organizations, while also robustly supporting European customers with EU-specific requirements, including MDD, GDPR, and WEEE.

Want to learn more about how to avoid the common pitfalls of decentralized clinical trials? Join our webinar on Tuesday, July 14, at 1 p.m. ET:

Demystifying Decentralized Clinical Trials and Enabling Your Study for Success.