From ignition to turbo drive: the IgniteData story so far 

Our CEO, Dan Hydes, on the IgniteData story so far…

A few weeks ago, we had a full team get-together at IgniteData. After a year of intense growth, this was the first time many of us had been in a room together and met face-to-face. We looked around this room full of fantastic people and it got us reflecting again on where we began, and how we got started on this journey.

As founders, Rich (IgniteData’s CTO, Richard Yeatman) and I are often asked how we ended up setting up IgniteData. And how on earth we got into this space – working to design modern clinical trials for the future and creating a solution for the rather messy current lack of interoperability of systems being used. It’s an area that very few have tried to tackle – and those that have tried, have generally been large vendors, looking to create add-ons to their existing Electronic Health Record (EHR) offering. But the answer to why we – then a small startup – wanted to fix
the lack of interoperability in clinical trial systems is simple – because it was blindingly obvious that it needed to be done!

We’ve had a long journey to get there though, which you may find it interesting to read about:

Learning to run a business 

In 2008, I co-founded a business to deploy projects within the NHS, including educational websites, and feasibility and recruitment for clinical trials. This experience taught me lots about running a business and partnering with the NHS, but it also led to two huge things: firstly, while working on a project for King’s College Hospital NHS Foundation Trust, I met Rich; and secondly, we both saw first-hand the inefficient ways in which clinical trials are run in large research-active hospitals.

Ignition: IgniteData 

With our realisation of the way data systems are siloed in hospitals – and the challenges this leads to for clinical trials in particular – Rich and I formed IgniteData in 2014. Our express aim was to help deliver modern clinical trials, and we had the seed of an idea for a vendor-agnostic cloud-based system that would allow for the interoperability of these siloed data systems. In particular, we wanted to build a tool that would facilitate the safe transfer of data from hospital EHR systems to trial sponsors’ Electronic Data Capture (EDC) systems. Now known as EHR-to-EDC, this would address some of the enormous inefficiencies in how this process is done currently.

But the groundwork wasn’t quite laid for us to deliver our brainchild. A standard protocol for the exchange of healthcare data – HL7 FHIR – had just been released, but it wasn’t yet widespread enough to allow us to create a truly agnostic solution. We imagined something that would support the transfer of data between the many systems being used across different clinical trial sites, and across different clinical trial sponsors.

Bootstrapping the business 

So, what do you do when you have a great idea, but the ingredients aren’t quite ready for it to be implemented? Well, in our case, you park it, but you knuckle down, building a business that is ready to spring into action when the time comes. We spent five years providing services in the clinical trial space: mining EHR data to recruit patients for clinical trials, conducting trial feasibility studies, and running large real-world studies (including the extended Salford Lung Study for GSK). All the while, we were learning more and more about how clinical trials are run, and all the while reaffirming our idea that the inefficiencies in running clinical trials needed to be addressed.

Seizing the moment 

Finally, in 2019, we judged that the time was right to begin building the world’s first truly agnostic EHR-to-EDC system.

In addition to the revenue streams we had already built, we secured a grant from Innovate UK to build a prototype. And just like that, Archer our virtual research assistant, was born. Archer harnesses the power of HL7 FHIR protocols, and SMART on FHIR Application Programming Interfaces (APIs) to allow data to be transferred remotely, without the need for hundreds of hours of manual effort re-keying data.>

OK, maybe it wasn’t born ‘just like that’. 2019 was a year of intense effort. But, as it turned out, the emergence of the Covid-19 pandemic in 2020 only made the solution we were building – which would ultimately allow for less in-person visits to clinical trial sites – even more enticing. We received three further grants, in all being awarded over £1 million in funding to develop the tool.

Being selected 

If 2019 was when Archer was born, 2020 was when it got a chance to walk. We were approached by the EU-funded group, the EHR2EDC Consortium (led by AstraZeneca, Jansen and Sanofi), to be part of a vendor selection process for a new grant project.

It was an immensely proud moment for us when Archer was short-listed, out of 18 solutions, to be one of ten selected to go through a deep-dive assessment process. It was an even prouder moment when we were told that Archer had then come out at the top.

This was the beginning of our partnership with AstraZeneca and University College London Hospitals (UCLH) to deploy Archer and pilot the transfer of data from UCLH’s Epic EHR into AstraZeneca’s Medidata Rave EDC, for a large oncology study.

Going into turbo drive 

Our partnership with AstraZeneca kicked off yet more intense development effort, but 2022 has seen us turbo charge our mission.

In February, we announced a multi-million dollar partnership with ZS Associates, in another very proud moment for us. ZS’s investment as a minority investment partner in the business has developed into a deep partnership and strategic collaboration between our two organisations.

As founders, Rich and I feel incredibly proud that we were able to achieve what we have so far through revenue-generation and grant funding alone. But we’re also now equally proud to be partnering with ZS at this time, with so many exciting developments happening.

Trial sites across the UK – and beyond – are getting more and more serious about realising the value of their data systems. King’s, where Rich and I first met, are set to implement Epic across a number of London NHS Trusts. And we are now in conversations with sites and sponsors across the globe that are looking to streamline their processes to deliver the modern trials that the industry – and patients – need. We couldn’t be prouder to be playing a pivotal part of this seismic shift happening in the industry. And we couldn’t be prouder of the team we’ve assembled that is helping us do it.

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