Improving Research within the NHS

By Simon Taylor, Head of European Solution Consulting

‘The first place it’s written down is the first place it’s documented.’ – Co-ordinators, everywhere

If it’s not documented, it didn’t happen. The problem is, WHERE it’s first documented matters as much as what is documented, so what do we do about that?

In this blog and our offerings at RDF ‘23, we’d like to introduce the way we solve this crucial issue at Florence Healthcare.

Getting rid of the paper filing room is still one of the most important and difficult challenges we see at sites all around the globe.

Certified copy is a process that allows us to certify a document as a legally binding equivalent of the original, which replaces the need for the paper copy entirely. Once a site is comfortable using the process, it allows the physical paper to be shredded safely and, compliantly, safe in the knowledge that the document you now have stored electronically is a legally binding equivalent. We may never be able to remove some paper transcriptions in clinical research, but we can make sure that paper is converted electronically as timely as possible.

Hand signatures represent a unique challenge in that they are unique to an individual and, at first glance, appear irreplaceable. Electronic signatures bridge that gap by making a digital version of a given signature that is just as unique to that individual.

21CFR Part and Annex 11 compliance are critical within research, and signatures are one of the most important places to ensure this; it also saves your Investigators and Coordinators a disproportionate amount of time.

Sometimes, we send emails for the sake of it,  to cover our backs, and usually, we send them because we think we probably should.

The issue with this is that email traffic becomes diluted, and emailing becomes a method of over-communication rather than necessary communication. So what’s the fix?

1. A system that notifies you of important upcoming work, with links directly to the task at hand. Just as important is a system that allows you to specify when you want to receive these emails (e.g. notify me every Monday at 9 am of every task I need to complete).
2. A system you can file emails directly in to ensure complete study and decision history alongside your documentation. A system that will file those emails for you, including any attachments, is a huge time saver through what can otherwise be a painful document collection process.

Clinical research isn’t conducted in a vacuum, so the data shouldn’t stay in one. The problem is without systems built for collaboration; data is at risk of staying in just one place.

Sponsors and CROs are more conscious now than ever of the risk of inspections, and Clinical Research is now in the public eye more than ever. The fix for this has always been ‘Oversight’, a wonderfully vague term used by agencies to beat Sponsors and CROs over the head to make sure they know what’s going on at all times. The problem is, Oversight became something from the top down rather than a collaboration.

A tool built for sites and built for industry collaboration allows you to give oversight without being asked; Remote Monitoring capabilities enable easy document collaboration and the reduction of needless onsite monitoring visits that take up time, money and valuable space.

The irony of Decentralised trials is that the site is essential for proper execution.

One of the larger challenges facing sites is the onus on decentralised trials and the site struggling to be able to adopt the new technologies associated with it.

We think the reason for this is that sites don’t have the fundamental technologies they need to take on bigger pieces of tech; as an example, those that don’t have an eISF or any electronic document management system will struggle to take on the big leap to complex trial technologies. Instead, we want to let our sites walk before they run, solve the biggest internal technology challenges they have, reap the benefits of that efficiency, to be then able to take on the DCT Tech from their sponsors.

When looking at your future technology needs and landscape, it’s important to solve the biggest issues before getting into the more niche aspects of DCT and complex patient technology.

Within the Florence platform, we understand the importance of NIHR studies and sponsor funding, as all NIHR studies can be run in the platform free of charge.

How your systems are connected and how data moves through them is a direct indicator of the health of your technology and critical data. Having a partner that is able to integrate into any other technology you may use (CTMS, EMR, EHR etc.) allows you to avoid vendor lock-in and prioritise the best user experience possible while ensuring seamless data flow and security.