Company of the Month: IgniteData
IgniteData are on a mission to transform the way clinical trials are operated in the UK and beyond. We spoke to CEO, Dan Hydes, as the company primed itself for the announcement of an exciting collaboration with AstraZeneca, and Dan filled us in on their brainchild, ‘Archer’.
Streamlining clinical trials
When Dan Hydes (CEO) and Richard Yeatman (CTO) formed IgniteData in 2014, they did so with a vision to streamline clinical research processes through the application of technology. Both working as business consultants in the NHS at the time, they saw an opportunity to take a more elegant approach to two areas that represent the biggest cost centres of a clinical trial: data management and patient recruitment.
Dan estimates that data management and monitoring accounts for around 40% of any clinical trial, and patient recruitment around 30%.
“Looking at data management, we saw the huge amount of work that goes into manual re-entry of data in a trial, and knew there was an opportunity to really transform this process using technology. If you conservatively estimate that 50% of the data you need for a study already exists in patients’ medical records, there is a staggering amount of work that highly-skilled people are doing to transcribe that data from one system into another,” explains Dan.
The seed of an idea was formed to create a tool that would allow data from patients’ Electronic Health Records (EHRs) to be transferred automatically to the Electronic Data Capture (EDC) systems used to manage trial data. This would have the potential to achieve significant time and cost savings for both the hospital running the study and the pharmaceutical sponsor, as well as removing the potential for transcription errors (which, again, add to time and costs via monitoring processes).
Waiting for technology to catch up
When the company first formed, however, the team found that existing technology wasn’t quite ready to facilitate the idea. Application Programming Interfaces (APIs – the interfaces that allow different software solutions to connect and transfer information from one to another) weren’t quite mature enough to deliver the required information.
So, they focused instead on the second largest cost-centre – patient recruitment. The first five years of the company were spent working with major pharmaceutical companies and contract research organisations (CROs), including GlaxoSmithKline and Synexus, on their patient recruitment processes, campaigns and communications.
In 2019, they decided to revisit their original idea to automate the flow of data, and this time, the timing seemed perfect.
“In the first five years of the business, our work in patient recruitment allowed us to learn a lot about NHS data systems, which has been hugely valuable. But in the background, the technology has also really matured. In particular, HL7 FHIR – which provides a common language for these systems to speak to each other – was in its infancy when we first looked at the idea, but has now paved the way for us to build a solution which we can adapt to work between different EHR and EDC systems.”
The company position their solution – named Archer – as a virtual research assistant. They believe, by vastly reducing the amount of effort in transferring data between systems, it should allow hospitals to run large numbers of additional clinical trials at the same time, using the same resources.
This brings us to the recent announcement of their collaboration with AstraZeneca… The collaboration, already meeting critical success factors, is piloting the use of their tool in clinical trials, initially at two leading NHS hospitals, with others to follow. Running Archer in parallel with traditional methods, the project will test and measure the efficiencies gained in time, cost and effort.
Speaking about the pilot, AstraZeneca Health Informatics Director, Mats Sundgren, described this as a “pivotal change… the next step in transforming the way we do clinical trials.”
One of the aspects of the company’s development that Dan is proudest of, is that their journey to-date has been funded entirely through revenue generation and grant funding. The company have been very successful in winning government support, and have been backed by over £1m in Innovate UK funding, across four different grants since 2019.
The emergence of COVID-19 has only served to attract more interest (and funding). The potential to reduce the numbers of personnel onsite in hospitals for data entry and monitoring is a clear advantage when social distancing is at play.
Now, with a solid foundation and product proposition, the company is in discussions with venture funds to secure the next phase of growth:
“Growing the business to this point purely through revenue and grant funding allowed us complete freedom and flexibility, and we think it’s a great example of what government funding can help businesses achieve. Now we’re at the point where investors are excited about what we have developed with Archer because it’s being validated with the tools and systems used by our pharma and hospital partners. Next comes the ‘cookie cutter’ market deployment phase that will allow us to help a significant volume of hospitals across Europe utilise our technology at scale.”
One might expect that the greatest challenge in developing systems involving sensitive patient data would be in meeting regulatory requirements. But Dan says that, while these challenges are significant, they are working closely with their pharmaceutical and other partners to work through them. One key aspect to protecting patient data, for example, has been ensuring that individual hospitals retain full control of the data transfer process. The company has also developed a good working relationship with i~HD (the European Institute for Innovation through Health Data – a neutral multi-stakeholder body established to develop and share good practices in the use of health data), which they believe has been a real asset in this regard.
Creating a unified solution that works with all the right hospital and pharmaceutical systems, to automate the flow of true regulatory-grade data for the first time, comes with obvious additional practical challenges, but Dan suggests the biggest challenge is actually in the scale of their ambition:
“The greatest challenge is the pace at which these (extremely large) organisations move. What we’re trying to do is bring them along on this journey, to deliver – essentially – industry-wide transformational change, which is no mean feat. But when you get success, and when the wheels start to move, it’s just so immensely rewarding.”
Plans for the future
Immediate plans for the future include completing their pilot studies and launching the planned seed funding round. The company are also about to welcome their first two female non-executive directors. In the context of International Women’s Day last month, Dan stresses that, whilst the founding duo are all-male, they are conscious of the value of having a diversity of voices within the company:
“Having a representative mix of people involved in the senior management team, as well as within the wider team is certainly important to us – it brings balance.”
To realise their ambitious aims, the team have also sought support from MedCity as they finesse their value proposition for the NHS:
“The number of new DigiHealth applications launched every day globally is mind boggling, so when you are one of the few organisations out there that really does have a game changer, you need all the help you can get to help you cut through the background noise. And this is precisely the role that MedCity, and other organisations like them, play,” says Dan.
While expansion plans are firmly focused in the UK and Europe for now, the company also have their sights on a global market:
“The technology is cloud-based, so, if a hospital in Texas was running a trial, we could deploy it for them just as easily as we could for our local hospital in Reading. So, while we’re focused on the UK and Europe right now, ultimately we see Archer as a global solution with a global market.”
Find out more – www.ignitedata.co.uk