F. Martin: There are the standard issues that eClinical technology companies face: so, the cost of a trial, the speed of a trial, site recruitment, and recruitment of patients will make or break any study that’s being done. The need to get to market faster, with fewer resources, is of paramount importance. Medrio is laser focused on meeting this need, providing our customers with the tools to accelerate their studies. We can get studies up and running between two and four weeks for a brand-new customer and then, if they are doing another study with us, on average just a little over two weeks. We help our customers speed up enrollment and the first subject live in the trial. This will enable them to close the trial faster, which in turn reduces the cost and shortens time to market.

Additionally, driving costs of a study down. When you’re looking at managing costs and working with sites, and if you are outsourcing, with CROs, how do you decrease your site data verification (SDV) costs? At Medrio we are the leaders in providing e-source solutions, where sites can enter the data right into the system in real time –the system is integrated into our EDC system – so it’s simplifies the data collection process and data transfer; but more importantly, it simplifies the audit and validation processes. So, again, we’re driving costs to some extent, around 35% in decrease in the SDV costs.

I think that’s really the challenge in the market place – to find the right technologies and solutions that speed time to market and decrease costs. Really, as I like to say, it’s democratizing clinical studies. Most systems hold their customers hostage due to the complexity of their systems. You need coders, you need programmers, you pay for simple changes, and you need experts who can really get into the back end of the system. Medrio has changed the paradigm by introducing a solution that is web based and easy to use. We’ve eliminated one of the primary the barriers that has traditionally slowed down studies: unwieldly software that requires expensive programming for study build and mid study changes. With Medrio, anyone can set up your study and partner with you, which makes it a much quicker process because you’re not dependent on a sub-set of people, you’re now across multiple clinical organizations that can do that study.

J. Hoech: I will add one more layer from a macro-economic point of view, about the kinds of cost reductions and technology trends that Fred has described. Companies are grappling with three fundamental market trends: 1) geographic shifts, 2) technology innovation, and 3) increased regulatory requirements. On the first point, the geographic shift is clear. When you look at the market data on where clinical trials are taking place you see: the American market is growing slightly; the European market is flat or trending down; and then the vast growth is in the Asian market, with more clinical trials being done increasingly out of places like China and Taiwan, and India. So, there’s low-cost competition coming in. They also have large populations of treatment-willing patients and they can really handle the bulk. China’s building up its own pharmaceutical industry and as you know, IP protection is not taken as seriously there as it is here.

Second, you have technology innovations that are driving a digital transformation in this industry. The days of paper-based clinical studies will soon be behind us, as adoption of new solutions like eSource and eConsent become mainstream, like the usage of EDC over the past decade. These innovative technologies continue to gain traction as a direct response to the need to accelerate trials and reduce costs.

Third, the regulatory environment continues to evolve, with increased scrutiny on data security particularly in Europe. It is critical to understand the nuances and intricacies of the regulations. Because you have this competitive threat from Asia and you have the regulatory requirements here, technology-driven innovation and cost reductions provide another way to get out in front of those issues. For example, where the entire data capture is completely automated, and you can bypass associated manual processes, that’s a massive cost reduction because the monitoring alone of such trials is often 50% of the overall cost. If you can take that out of the system, it’s a way to be cost competitive and improve the quality of the process. There are multiple levels at which the challenges occur, just to build on what Fred was saying.

F. Martin: Absolutely, I think that’s the other complexity in the market place now as these systems are growing and you need to get data from external devices and EHRs, and the list goes on and on and on. Interoperability is becoming more and more important, so I think that having a system that has the right connectors and hooks into the market becomes incredibly important. Systems have APIs, open-source APIs, to be able to connect out to data sources both bringing data in but also bringing data out. A lot of customers want to do their own analyses on the data, they want complex learning, complex cross-data analysis. Many vendors are trying to build those capabilities into their own systems, as we are, but a lot of customers already head to the marketplace. We must be able to build smart systems that have those hooks out there and understand not where the market is today but where the marketplace is going in the future, so that we’re building the right hooks for tomorrow’s technology that we haven’t even thought of today. New clinical trials are going to be brought out, and how do you bring more of their data into the system?

Addressing eClinical Data Challenges

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