Clinical Research and Data Management

Conversation with Synteract on the Opportunity for Innovation in Clinical Trials and the role of Process, Data and Technology

By Richard Clements, Chief Marketing Officer, ThoughtSphere

I recently had the chance to speak with a client and partner of ours, Gareth Adams, Vice President of Synteract OS at Synteract. Synteract is a full-service contract research organization (CRO) that has managed 4,000+ clinical trials across 62 countries. Our conversation was wide-ranging covering Synteract, the state of clinical trials, and the role of technology, people and process. Here are some excerpts from this very candid conversation.

Me:

Let’s just get right into it. Can you tell us where Synteract is focused and what makes Synteract different from other CROs?

Gareth Adams:

Synteract has 30+ years of global experience and what we’ve focused on establishing the last couple of years is our Centers of Development. We have Centers of Development in six different areas – Dermatology, General Medicine, Neuroscience, Oncology, Pediatrics, and Rare and Orphan Diseases – and we are targeting the market in those areas. Our CEO has been a huge technologist all of his life and is always looking to technology as a key differentiator in the marketplace. In combination with our Centers of Development, we are keen to introduce technology that helps us as an organization. Technology helps our clients because it gives us and them the ability to progress and to differentiate and innovate in the drug development space.

What differentiates us is the expertise and experience of our development leaders, the great resources we have globally, coupled with cutting edge technology. There’s a real buzz with existing and new clients alike.

Me:

Tell me about your role at Synteract. What do you see as the primary challenges you face?

Gareth:

I’ve been in the industry for nearly 25 years and during that time there has been a tremendous change in the industry. I started in operations and data management. When I started, everything was paper-based. In 2010 I headed up global data management for one of the top five CROs and I was picked to lead an initiative at that CRO on how we could better use technology and process to, not just drive efficiencies within the organization, but to do things differently. This was particularly relevant in light of some of the emerging guidance that was coming from the regulators about risk-based monitoring.

That led me into this period leading big enterprise initiatives on innovation. In 2017 I came to Synteract as Vice President of Synteract OS. Synteract OS is a corporate development team. We’re not in any of the operational business units and operate as a sort of business solutions consultancy to the entire company. My team is pretty diverse in its skill sets. I’ve got domain experts in business process mapping and design, project management, enterprise information management and I have a small team of developers as well that can deliver internal solutions to drive the organization forward.

We’re focusing on process, data, and technology across Synteract. The three go hand in hand. I’ve been in the industry long enough to see projects that have failed because the organization has not given due consideration to how all three elements must be considered together to ensure a successful initiative or endeavor. My team at Synteract has been constructed with that specifically in mind. We can support the organization, whether it’s looking at processes they want to review and redesign, or better use of data within the organization. And of course, we look at the role of technology, in alignment with process and data, to support the organization in driving clinical trials and data management forward.

The second part is the biggest challenge I face and it’s not just me. It’s a challenge across clinical trials and the life sciences industry. Despite changes in regulatory approach and continued development of the technologies that we’re all using, we are years, if not decades behind other industries in real innovation, not just in doing things differently but doing different things. The regulators have tried to remove some barriers to innovation with recent guidance from the FDA, and EMA, and particularly ICH with the R2 guidance. But the industry changes slowly; it is naturally “risk-averse”. The challenge to me and what I want to help drive is more significant, rapid change across the industry that combines process, data and technology.

As an industry, we are not good at leveraging data for decision making outside of the regulated clinical trials and data management process. Every CRO and sponsor has huge amounts of data available to them, but the data comes from disparate data sources, from different places. The challenge the industry faces is trying to bring all of that data together – employee data, project management data, timesheet data, financial data, and clinical data – and trying to make better decisions about a trial and how we conduct a trial. As an industry, there’s a huge opportunity to leverage this data in an aggregated fashion to drive innovation and be forward-thinking, to advance drug development at a quicker pace.

Me:

You talked earlier about knowledge, resources, and cutting-edge technology. When your clients look at Synteract, what’s most appealing about Synteract to them? Why do they choose Synteract?

Gareth Adams:

I think first and foremost, because of the way we’ve aligned our expertise into our specialized centers of development, we’re able to go to clients that are running more complicated protocols and put a fully formed team of experts at their disposal. This team ranges from the VP leading the specific center of development who is a subject matter expert to the project manager who has worked on global projects, leading a cross-functional team that has had to start sites across multiple countries. They’ve been in the trenches and they understand what’s going on. We’re able to sit in front of each client and say, “Yes, great protocol, excellent study plan, but have you thought about this? Or considered this? Based on our experience, we’d strongly recommend this approach, because it has worked before.” And we have the evidence, and the expertise and the data to back that up. Our clients are receptive to that. We engage strategically very early on in the proposal and bid process and that resonates well with clients.

Also, something that resonates is the size of our organization. We are growing, we are a global CRO, but we’re not a behemoth. Clients enjoy working with our project teams. We’re still at a size that allows us to be flexible and adapt fairly quickly to the requirements of the clients and their unique studies. So, I think it’s a combination of these things. It’s great people. It’s great service. It’s great technology. Clients know we genuinely care about them, their project and delivering for them.

Me:

You touch on technology and certainly, there has been a lot of news in the marketplace about using technology to improve clinical trials and data management processes. Talk a little bit about the role you see for technology.

Gareth Adams:

A mistake a lot of companies make is they think technology by itself is going to solve their issues.

Which in rare instances it will. But technology is a small part of it. How are you going to deploy that technology? What’s the impact on the processes? What problem is technology going to solve? What process is it going to replace? Is it going to create additional work? If you don’t consider all of those questions first, technology can be a burden. I think you need to understand an organization first and then look at technology as part of a three-pronged approach. First, what are your processes? Second, what are the problems that you have, or you’re trying to solve? And, third, how can you do that with a combination of process, of the technology, and then the data and information to make decisions? And that’s when you start to get successful leverage of technology.

Me:

Now Synteract recently chose ThoughtSphere as a core technology component of its go-to-market offering. When you looked at ThoughtSphere what problems specifically were you trying to solve?

Gareth Adams:

I think one of the biggest challenges that face many CROs and clients is how can I make better decisions? Where is the data? With the information that I need as a CRA, as a project manager, as a vice president of Clinical Operations, I have decisions to make. But, we’ve got so many different data sources available to us just within the clinical trial…CTMS systems, eDC, labs, imaging, ePro, etc. You already have, on any given clinical trial, six or seven specific clinical data sources just for the regulated trial. Then you have all of your corporate and enterprise-level data sources as well that sit around your clinical data-, your employee-, project-, and financial-management systems. All the reports from these disparate systems are not directly contributing to every clinical trial in terms of the regulated process, but they’re sources of data that feed into it and impact how you make decisions.

If you can start to bring all this data together into one platform and deliver an aggregated view back to a project team, you’re already starting to improve that decision-making process. Project teams can start to access clinical and operational data in aggregate and start to get the benefits of access to holistic project information. I think first and foremost that was a big plus for us. That’s one of the main things we were looking for when we worked through vendor selection and chose ThoughtSphere.

Companies have a choice. An organization can choose to build proprietary technology in-house – with all the infrastructure needed to support that internally. The effort is massive, takes years and often costs millions of dollars, and they are still not where they want to be. Typically, companies don’t meet the goals they set for themselves four or five years previously.

We had that choice. But instead, we chose ThoughtSphere, as it offered a different and preferred approach. First, I call ThoughtSphere a data engine, because it gives Synteract a powerful platform to capture data from almost any data source, aggregate it, and standardize into a common data model. This data engine sits at the heart of every clinical trial we run and provides easy-to-use dashboards and data visualization. ThoughtSphere allows access to data nearly immediately, from which clear, actionable insights can be derived.

Also, ThoughtSphere provides study workflow and risk management capabilities. We can use this tool not just for delivering information back internally and to our clients, but we bring the tool into our processes to directly interact with it and help with decision making within a fully regulatory aligned and compliant technology.

Me:

You mention the selection process to choose ThoughtSphere. What is the core reason you chose ThoughtSphere?

Gareth:

Super smart people. What I mean by that is there are lots of technology vendors serving the life science industry, and there are some cool products out there. But often you’ll find these products were designed by someone who has never worked on a clinical trial. So, you have to ask how it fits into the CRO or aligns with its processes. With ThoughtSphere, I knew Sudeep Pattnaik, your CEO, and Pankaj Manon, your CTO, have “been there, done that”. They have worked in the clinical trials and data management industry and understand how technology needs to be built to be used effectively to run clinical trials. And that’s very evident the minute you see the technology and how someone interacts with it. It fits how a CRO works. They’ve leveraged their operational knowledge as well as their intelligence from a technical perspective, into a piece of technology that not only slots into how a CRO operates and runs current processes but gives us the flexibility to improve our processes.

Me:

As Synteract starts to work with clients using ThoughtSphere, what are some of the business benefits you’re hoping to deliver to your clients?

Gareth Adams:

The biggest one, and this goes back to some of my comments earlier, is that we would like to help evolve our industry. We’d like to help shift the current drug development paradigm by giving our clients actionable insights that get them to critical decisions faster and with more certainty.

One of the real benefits and one of the real eye-openers for clients is we can show them all of their data in one system. We say, “here’s the platform where you can look at all of your clinical data and your operational data across the study.” Typically, clients have never had this aggregated access before. With this whole new perspective, questions and dialogue begin on the possibilities that come from this access to data.

And then we look at the holistic risk management the system provides, where issue identification, tracking and resolution are all maintained in the system. It’s moving clients towards that “single-source-of-truth” they can access, not only to get the information, insight and oversight of their study but ultimately to the system they use for their data review.

The technology is, in some instances, ahead of where clients are. So, we’re actively engaged in providing insight to understand this slightly different way of working. But as clients learn more, many quickly ask, what else can it do? And it’s fascinating having those conversations with our clients.

Me:

Gareth, thank you, I appreciate all the insight. In closing is there anything else you’d like to comment on?

Gareth Adams:

We don’t consider ThoughtSphere as a vendor. We’re working with like-minded individuals that are trying to solve problems within the clinical trial industry. ThoughtSphere Cloud is an amazing platform. The potential of the platform, not just in delivering the capabilities that it can now, but how you integrate that with a company’s processes, and delivering information and data back to an organization is huge. We are working with innovative people on how we can do different things, not just doing things differently, and we are enjoying that. We’re excited about where we are now and I think equally, if not more excited, about where this relationship can go in the future. Between us, we can begin to shape the clinical trials industry and drive innovation that will transform the way we do business, in bringing clinical trials to life.

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