Guaranteeing data security in decentralized clinical trials


Wearable devices – such as continuous glucose monitoring systems – have been a game changer for the healthcare sector, providing the real-time data needed for patients to monitor and manage their overall health and certain illnesses at home. Similarly, they are now also being used to good effect in some clinical trials, allowing screening and monitoring to be undertaken at patients’ homes and local clinics rather than them needing to travel to specialized sites. This approach, however, relies heavily on the collection, transmission, and storage of remote streams of patient data, and the digital ‘chain of custody’ of this sensitive information is paramount to ensure patient privacy, regulatory compliance, and study validity. 

Data security in a trial setting

Data security is especially important to guarantee when running decentralized studies like these, where data is collected off-site and potentially sent to a central location for analysis. Secure transfer of this information stream is imperative in maintaining patient confidentiality and impartiality, as well as preventing sensitive data from falling into the wrong hands. Ultimately, electronic information’s greatest strength – its ease of access – can also be its greatest weakness, so it is crucial to consider the flow and visibility of information in relation to the trial design, since any dissemination of data to a blinded party may introduce bias and compromise the validity of the study. In addition, clinical trials – much like standard healthcare practices – must comply with mandatory guidelines like the General Data Protection Regulations (GDPR), Code of Federal Regulations (CFR), and the Health Insurance Portability and Accountability Act (HIPAA). 

With familiarity comes opportunity

Patient populations too are more aware now of the importance of security; the day-to-day use of connected technologies is on the rise across all demographics – even in the elderly – and, because of this, people are becoming increasingly comfortable with how these devices operate and handle their sensitive data. This presents an opportunity to incorporate more patient-operated digital technologies into decentralized and hybrid clinical studies. However, it is essential for trial sponsors and CROs to coordinate with experienced equipment suppliers – like Woodley Trial Solutions – to ensure that data is handled appropriately.

We have over 30 years of experience in supplying sites with regulatory compliant hardware and secure data management solutions, and our dedicated sourcing team – working hand-in-hand with our approved data partners – are here to satisfy your specific needs, no matter how complex the requirements. For example, we regularly partner with remote patient monitoring specialist Glooko, which has developed a medical and research-grade platform that is CFR, HIPPAA, and GDPR compliant, ensuring the secure transfer of data to the relevant parties in near real time. Kevin Dougherty, Glooko Vice President of Business Development, explained: “Our rigorous data protocols ensure that information is being managed appropriately, complying with both regulatory guidelines and trial blinding criteria. The platform also integrates seamlessly with a wide range of devices – including continuous glucose monitors, insulin pens, and smart scales – making it the ideal solution for a wide range of decentralized and hybrid studies.”

Be sure to join Woodley Trial Solutions at the 14th annual SCOPE conference in Orlando, FL. Find us at booth No. 414 on February 7-8. 


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