Between demand in the market and trends that support its enablement, decentralised clinical trials is a growing area of IoT. According to a recent EY-Parthenon survey of Contract Research Organisations, biotech firms, and pharmaceutical companies, the current clinical trial landscape is split as 60 percent traditional; 24 percent a hybrid model of in-clinic and remote; and 16 percent are fully centralised. However, survey respondents estimate that by 2024, the percentage for hybrid and fully decentralised are expected to grow to 28 percent and 22 percent, respectively.
As EY-Parthenon suggests, organisations in the life sciences industries are looking to grow the ability to decentralise clinical trials – whether partially or fully – the landscape is buckled with many complexities.
Decentralised clinical trials (DCTs) have a host of benefits, but deploying and managing can be difficult, and the ROI might seem murky. The challenges that CROs, pharmaceutical companies, and biotech firms face include:
Data qualifying: While the volume of data collected is certainly a benefit, because the greater the data collection, the greater than analytical capabilities, it can also be a detractor if proper analytics aren’t applied to the data being collected. Having too much data and not understanding what is quality data gives little value to the information coming in.
Security and compliance: With any solution that requires communicating via the internet, security is going to be a concern, but it is a particular concern in healthcare solutions due to the sensitivity of the data, the critical nature of the applications, and the strict regulatory compliance in healthcare. Without secure patient communications, clinics face punitive non-compliance measures. Building secure, compliant solutions in-house is challenging. Working with experts who are regulatory compliant can lighten the load in bringing DCT solutions to market.
Mobile Device Management and Data Telemetry: Mobile Device Management pairs functionality between the gateway and the peripheral devices that allow for remote unpairing and pairing of deployed devices.
Logistics: Include hardware sourcing, device conﬁguration and kitting, connectivity management, as well as forward and reverse logistics. Through managed services, CRO's, biotech firms, and pharmaceutical companies can deploy IoT-enabled clinical trials without the hassle of managing the logistics, connectivity management, and device conﬁguration in-house.
KORE Connected Health specialises in enabling DCTs, remote patient monitoring, and cardiac rhythm monitoring telemetry bundles, among others, that make bringing healthcare technology solutions to market faster, easier, and compliant. KORE ties together hardware, global connectivity, Mobile Device Management, and managed services for logistics, device lifecycle management, as well as staging and kitting. KORE can package and conﬁgure hardware and peripherals that work out-of-the-box upon arrival, whether it’s to a clinic or direct-to-patient.
Join industry experts and thought leaders at Clinical Trials Europe in Amsterdam November 7th-9th. KORE will be sharing information on how we make the path to decentralisation simpler, more attainable, and with greater ROI through our compliant managed services, connectivity partnerships, and more.
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