Richard Yeatman: I am the Chief Technical Officer and one of the founders of IgniteData. My background is in computer science. I spent several years in global IT support, and then went into consulting in healthcare services on big data. I helped hospitals implement technologies like personal health records and electronic health records (EHR). At King’s College Hospital I met one of the other founders of IgniteData, Dan Hydes, our CEO. We wanted to use data in healthcare to help pharmaceutical companies run their trials better.

Qin Ye: I’m a partner at ZS. I’m a physician by training, with an informatics and computer science background. I’ve always been passionate about healthcare and data technology. I spent about 10 years with AstraZeneca and Pfizer using data and medical expertise to help life science companies develop their products and demonstrate value. I have also worked on the healthcare IT side with EHR. At ZS, we help pharma to take a more data-driven approach and embrace innovation to bridge the gap between patient care and clinical research.

Richard Yeatman: Even now, in 2022, global clinical studies are being conducted on giant electronic data capture (EDC) systems, where data must be entered, even though up to 50% of those data already exist on the EHR. That is a timeconsuming process and most hospital data managers are behind with their study data entry work. They are only human and they make transcription errors.

This has resulted in a booming monitoring market, as sponsors worry about the repercussions if these data are entered incorrectly and then reported to a regulator. CROs are making huge amounts of money from sending monitors to sites to conduct source data verification. It is important to be accurate, but we must find other ways to make the sites more efficient. We’ve heard about patient centricity, and now we need to look at site centricity and help them improve what they do. That’s where the idea for Archer originated.

Archer is about achieving interoperability with hospitals to help them automate their data into EDC systems. It is about providing hospitals with a tool that plugs into their EHR and gives them control. It helps them to find the right data on a hospital record. It helps them analyse that information. It gives them oversight of the data that are leaving the hospital. Because the hospital is responsible for reviewing and checking it, it maintains its 21 CFR Part 11 data integrity compliance.

Through automating the data, the Archer technology alleviates the pressure on hospital staff and reduces monitoring costs.

It’s only possible to do this now because of the evolution of things like HL7 FHIR (Fast Health Interoperability Resources). The US 21st Century Cures Act 2016 forced EHR providers to start introducing interoperability APIs and HL7 FHIR became the standard in the field. Half of the UK EHR market is US companies. We built a scalable, cloud-based technology to connect to sites, giving them the control.

Qin Ye: In 2018, the FDA published the first of a series of guidelines on the use of EHR data in clinical investigations. It stated that it wanted to promote interoperability between EHR and EDC systems. The 21st Century Cures Act gave a clear mandate for the FDA to think about how to bridge those two worlds, which did not have enough interaction. The FDA is setting the gold standard for many stakeholders. It wants to encourage the use of data while ensuring its transparency and universality, as well as making sure that the whole process is accounted for and explainable. It wants to learn from those data to make informed decisions that will still protect patient safety.

The evolution of real-world evidence and how we conduct clinical research will converge. The industry wants to create a non-biased and sustainable approach to demonstrate product value. This ability to connect the two worlds and build solutions that are transparent, efficient, and streamlined, could be the reliable future for us and for the patient. It’s not a siloed and tactical approach and only addresses clinical data collection efficiency. Rather, it is about seeing the possibilities of how this interoperable technology, and the things we can build around it, can truly change the way we develop drugs and prove their value.

Richard Yeatman: The question we faced was how IgniteData, a small British startup, with an Innovate UK-backed technology, could roll out Archer in countries all over the world. Thankfully, Qin and his team offered us a partnership. They said, “We know exactly what you’re doing. We know exactly why you’re doing it. And we want to get there as well.”

One of the most important things about the partnership is the fact that ZS are not a pharma company or a CRO. They’re a disrupter, but they have relationships with so many of the large pharma companies and health institutions around the world. It is vital that the technology is not owned by a pharma company or a CRO. It needs to be unbiased. The hospitals, particularly, need to know that it has interoperability with all EDC systems, otherwise it doesn’t solve their problem.

We also need to move to a world of ‘eSource-ready’ sites. An eSource-ready hospital is one which has an EHR system in place, getting rich data, rather than lots of disparate systems, and they’re starting to make things like HL7 FHIR APIs available so that tools like ours can plug in and interoperate.

This is a journey that the whole industry must go on together. EHR to EDC is a ‘tide that lifts all ships’. The sponsors need to encourage hospitals to realise that if they invest in this technology, it can work effectively and bring positive knock-on effects. The more eSource-ready sites they have, the faster we can roll out the technology. In the UK and the US, where huge amounts of research happen, that journey is already underway, so we’ve got lots of places to approach so we can prove the research.

Qin Ye: The industry, public agencies, and the prominent research sites have made significant attempts in the past. There was the EHR4CR initiative funded by the EU Commission with pharma participation, for example. But many prior efforts couldn’t achieve the full potential at the time when there isn’t the foundational technology to back them up. Having the passion to drive change doesn’t automatically translate into practical applications or improvements. The adoption of HL7 FHIR, combined with almost universal adoption of EHR across the Continent is starting to make the situation look favourable.

At the same time, adoption requires more of an ecosystem. All the key players in the clinical research and development space need to see that there’s a value for them to make that change.

Whether it’s on the sponsor side, the health system side, or even on the CRO side, change only happens when technology maturity and becomes more practical. These stakeholders need to see the potential disruption of today’s processes and the benefits to the work that they are already doing. ZS, as a global consultancy, works with the top pharma companies. We have a presence in 28 cities globally. We want to enable a more connected health ecosystem. I think this innovation, among many others, can really help the researchers to participate in research in a much more effective, reliable and sustainable way.

Drug development costs have skyrocketed over the last 20 years. Much can be improved, including duplicated processes and wastage. Connecting those two worlds will be one of the disruptors that will help to reduce costs, bring innovation to the market faster, improve patient outcomes, as well as benefitting site research institutions and medical centres.

Richard Yeatman: The main challenge is getting from where we are now to where we want to be. It is a transitionary process involving the pharma companies doing the research, the hospitals and the pharma company sponsors. The sponsors are at huge risk if they get any of their data wrong, which makes them conservative and resistant to change. We must go through a long process with these organisations. They won’t accept the findings of another sponsor. They plug in your system, they want to see a synthetic payload of data go through to their EDC, they want their EDC experts to come in to assess it, and then there are the regulatory issues that sit around it, too. You must build trust and confidence. There’s a high barrier to entry but, if you can get there, you can do brilliant things.

The same applies with hospitals. You have to meet and discuss it with them. We don’t charge hospitals for implementing the solution, but it still drains some of their resources to do it. One issue in the UK is that Epic is becoming popular as an EHR with lots of Trusts. We can integrate with Epic and can get rich data for clinical trials. However, there is a finite number of Epic engineers and when hospitals with bigger budgets take them, nobody else has access. But we’re working with the stakeholders and these worlds are starting to collide.

Qin Ye: We are closely following the regulators, who seem to be encouraging the use of real-world data to support decision-making. We will work closely with IgniteData to build an industry consortium to drive adoption of EHR-EDC integration more rapidly. IgniteData has taken a very methodical and rigorous approach to building and developing the platform and, over time, openness to the technology will grow as its value becomes clear.

The same collaborative approach is needed on the research networks and the health system side. Changes will happen more rapidly when organisations see the collective value and the cost of implementing innovation reduces.

There’s a lot of potential around increasing automation, as well as in introducing more end-to-end solutions to help bridge gaps in research. Researchers are facing a lot of challenges. Professionally, they want to participate in clinical research, but it is an expensive, complex, and inefficient process. For example, research sites have to jump through a lot of steps to be enrolled into a study. In the end they may find they don’t have the right patients to meet the complex criteria. Then, as discussed earlier, once engaged in the study phase, there is duplication of many processes that take time away from the clinical staff instead of patient care. So, we want to create a research ecosystem powered by innovative technologies and multi-stakeholder collaborations to assist research sites globally to improve patient outcomes.