Investigators and site coordinators 'don't want to hunt and peck through information - they need a one-click solution' says OpenClinca CEO

It does this by enabling more efficient clinical research through smart clinical data management and automation. ​The company says those working on trials want to recruit patients and spend more time with them. We talked about the difference between what OpenClinica is offering compared to others, its relationship with the University of California and Quantum Leap and of course, artificial intelligence. 

OSP: I'm just going to start off by asking you why you come to DIA and what message you hope to bring to this year’s conference?​

CC:​ We come down to DIA because it's a great meeting place for folks that are interested in clinical trials software solutions, which is what we offer and, just in general, how to improve the process of running clinical research. It's a great, great place to see people who have very diverse perspectives and roles all under one roof and to learn from that.

As a company we've been coming for over 10 years. This is our first-time back exhibiting in a few years, due to the pandemic.

OSP: So, would you say this is an area that still people have been adopting slowly? Or would you say more and more people are looking to use real world data, what's the issue with it? ​

Real world data and particularly from my perspective, we focus a lot on direct integration with electronic health record data, which can be used in real world contexts, or in a traditional clinical trial context just to replace the onerous and expensive manual transcription of data that that still happens in most trials.

So yeah, we talked to the end users a lot. Everyone wants this. Nobody likes entering data from one system into another and then having to have somebody look over their shoulder and check it all the time. That's not the highest and best use of investigators or site coordinators. They want to be spending more time with patients, recruiting patients onto their trials. So yes, we see tremendous interest in that.

It does this by enabling more efficient clinical research through smart clinical data management and automation. ​

OSP: How does it work? How could you sell it to somebody who'd never heard of it?​

CC:​ Think of it like this, you're part of a clinical research study at the at the site, you have to log into your system of record and Electronic Health Record system in a lot of places, hunt and peck through the information there that's relevant for the clinical trial and then usually on another screen, log into your data capture system.

Then you must put that information into an electronic case report form. We offer it this way, right from a button in the patient chart in the health record, just one click to launch right into the CRF and then even better, auto populate that with data that's already in the record. So, you don't have to hunt and peck and enter things manually from one place to the other. And so, it is an incredible timesaver, increases accuracy of data and completeness of data and you know, it's also more secure.

OSP: Okay, and is there potential for further development with it? Or would you say it's at where it needs to be?​

CC:​ I think two things that are really exciting right now are the breadth and types of data we can support in the automated transfer context, it continues to expand as standards and healthcare for structured data, continue to develop and get adopted. So, we've had great success with core data, things like labs and medications and diagnoses - and procedure data. But that continues to advance in the scope of what's possible so we can unlock more of the data that may have been traditionally captured in clinical narratives or text base, as opposed to structured data. The other exciting thing is, is the approach we use to do this integration, which is a technology framework, called SMART on FHIR, which continues to get more and more adoption and support and awareness across the healthcare industry. So, it's part of several regulatory mandates and well supported by major vendors on the healthcare side. So, it's just getting easier and easier to implement these integrations.

OSP: I noted in something I read about you, that you believe the key is unlocking real-world data. Is that something that other companies are doing or unique to OpenClinica?​

CC:​ Well, I think, you know, one of the great things about the that particular technology approach was SMART on FHIR - it's not unique to research, right? It's a set of it's an approach for reusable integrations and apps across healthcare, which means it's, it's gained that wider support a more universal support. So, it's much more plug and play than trying to do some type of integration that's unique to research - which is a small piece of the pie when it comes to health IT and health data overall. We think it's a great fit for research. We've collaborated with customers and implementers of ours, we've worked closely with the Food and Drug Administration on the regulatory compliance aspects of things and you know, we see other folks in the in the industry taking the same approach.

OSP: What sort of hoops do you have to jump through for the FDA to be on board and support what you're doing?​

CC:​ We've had the opportunity to collaborate closely through a customer of ours, Quantum Leap Healthcare, who powers the I-SPY adaptive platform trials. And in the University of California, San Francisco, to really explore some of the questions and relevant topics related - we look carefully at the guidance that FDA has issued around e-source and use of electronic health record data, to make sure that when we're doing an implementation and setting up a study, we adhere to all those requirements, carefully tracking where data came from making sure that in the audit trail that it's traceable back to source being a certified electronic health record system.

OSP: As devil's advocate here, what happens if the whole thing crashed and went wrong, and all this data just vanished? Has there been a lot of work to make sure that doesn't happen, and everything is fully backed up and saved?​

CC:​ Absolutely. So, you know, we've, we've been in the electronic data capture business for 15 years now or a little more, I think. Our solution for EHR integration runs on top of our EDC platform, so the data is all going into the same place. It's not a new technology. It's a new layer, a new set of capabilities on a technology that's been proven. And we have really robust infrastructure with multiple levels of backup and no single points of failure to ensure that nothing like that is going to happen.

OSP: A curveball question again if I may. I'm curious to know what you think of artificial intelligence. It seems to be everywhere, a particular buzzword at DIA. It seems to me that you've got one side who think it's utterly terrifying and could threaten our jobs and the other side who wonder how we ever lived without it. What's your sort of gut feeling about it?​

CC:​ I think, for what we do – research - where there's such high bars for consistency and validation, then the ability to explain what's emerging, I think it's I think it's fascinating and exciting. You know, it may be a long time before we're using it autonomously, but some of the new technologies related to understanding text and unstructured data can be incredibly helpful, because there's so much of that in healthcare records. We're at a point now where everything ultimately needs to be reviewed and verified by humans if you're doing that type of natural language processing, but it can be an incredible enhancer of productivity to help automate that and ultimately down the road you know, it may get rid of the verification step but I think we're a long way from that.

OSP:​ Sometimes. expressions like organ on chip and things like that sound a bit far out to me – and quite daunting. I've said it to somebody before because I think in the UK with the NHS that way it is, there is so much wastage of time and manpower. I still had to go up to my doctor the other day with a handwritten note because I couldn’t get an appointment. You’d like to think those days are gone, wouldn’t you?

CC:​ I mean, it's an industry that single-handedly has kept the fax machine business alive for a while now. And I think we all know it's a complex industry. And change comes slowly sometimes. We see the adoption of electronic systems, global standards for interoperability that are modern. And reusable and easy to implement. And the demand from patients and from various sectors and in the industry for better solutions is driving a lot of change to come in the next few years.

OSP: And aside from the US, where would you say the focus is going to be next?​

That's a good question. I'm part of the Vulcan Program which is Health Level Seven’s (HL7) newest, Fast Healthcare Interoperability (FHIR) which is a great example of an organisation that's working in the US but also globally to promulgate and advocate for the use and support of data standards for research and EHR interoperability. So, we're building that base in Europe. And it seems the UK is definitely one place where there's interest and there's momentum for it.

OSP: And finally, to end, so I can let you enjoy the show, what has been the best part of your journey with the integration technology?​

For me, the most eye opening part of what we've been doing in this area for the last few years was when we started to turn on - not our first site because we had worked so closely with the University of California, but our second and third and fourth site using this integration technology expecting differences in how this side or that side implemented things or what we're seeing for data and instead we saw the lights go on and the data start flowing and a really smooth, consistent, repeatable process. And to me, that's, that's the thing about integration is if you have to do it, it's unique to everyone, it doesn't scale. And here we have a way of doing things that are scalable and repeatable. And that's, that's what's exciting about going forward.