Tell us about how you started Devana
The genesis was when I was running a site along with my main business partner and one of our key managers. We observed a lot of inefficiency in the study startup process. We didn't have a good way to track milestones from initially hearing about a lead all the way through award date, SIV date, first patient in and so on. When we networked with other sites, we found that none of them were using anything other than static spreadsheets for this.
At the same time, we began hearing from larger CROs that they were keeping metrics on our site including metrics on fast we performed in start-up and, of course, screening and enrollment performance. We knew our site was a top performer in our core indications; but we learned that one of the largest CROs had our site on a blacklist, so we tracked them down. The person who maintained the database told us that we were a "zero enroller" on 6 studies. However, their conclusion was based on the fact we were awarded 6 studies; but, in reality, for various reasons, we never actually contracted for those studies. For example, in a couple cases we had competing studies so knew we might struggle enrolling on two very similar trials and, on a couple more, the budget being offered was not sufficient. For all six studies there were valid reasons we passed; but, that CRO's bad data was standing in the way of our site being considered for future trials.
Based on this painful experience, we quickly realized we needed to take control of our own site performance metrics. That's when we conceived of the idea behind the Devana Solutions technology. Our software enables sites to keep track of their study pipeline, track critical metrics such as turnaround time on feasibility, contracts, budgets and run reports across start-up milestones and enrollment performance.
By the way, one thing we learned is that many of these CRO's, despite even their own size and sophistication, aren't using very robust systems themselves. Many times, it's their spreadsheet vs. the site's.
So you know a lot about business development. What is the key to business development?
Obviously, you have to be a good site. Let's assume that for the sake of discussion.
For business development purposes, you need to develop strong relationships. Clinical Trials BD like all sales is very much a people game. A good business development professional is someone who can work independently, is self-motivated and can build and nurture relationships. But, since it is heavily regulated, the clinical trials industry is very paperwork-intensive and study start-up can take a long time. From the time a site gets the first lead about a study to the time it receives an award letter and is greenlighted to begin enrolling, people at the site will, on average, interact with 7 to 8 different people from the sponsor or CRO. Part of this is because of specialized roles at each step of the process, and part of this is probably just natural position changes or turnover. So, a good BD person needs to navigate these relationships and transition effectively, and to do that he or she needs tools to efficiently manage workflows and continuously assess how the site is performing.
For that, you need some kind of a system to track and capture your site's own performance metrics. Why cede control of your destiny to someone else that says they're tracking your performance? You should have, at your fingertips, information on your pipeline, your past performance and the specific milestones and metrics of every study you're working on or have completed in the past and Devana technology does exactly that.
How much does a Business Development professional cost? What do you do if you're a small site?
My guess is they can range from $80 to $150,000 dollars a year depending on the market. Add conferences and travel, and you could be easily looking at a $200,000 annual investment. So, a dedicated BD role is something that usually requires a site to generating $2 million of annual revenue or more.
For smaller sites, joining a network may make a lot of sense. That way, you're combining efforts and using that scale to invest in a business development function.
We hear a lot about site metrics. Who is collecting them, and what kinds?
A lot of people are collecting these metrics. The large CRO's and Sponsors are doing this. Software vendors are. Industry consortiums such as Transcelerate are likely taking steps in this direction.
At the site network I was a part of years ago, each month we'd meet with the top CRO's and review site study performance and the CRO's current pipelines. They were always tracking how our sites were performing in the start-up and enrollment process ‒ how many patients each site screened, randomized, etc. Most of the CRO's were using their own systems to capture these metrics.
I want to stress again how important it is that sites track their own metrics. Because there are other study stakeholders trying to track progress, it's incumbent upon sites to be engaged in the dialogue and know their metrics cold.
What do you think of the rise of site networks? Do you expect this to continue?
Consolidation is here to stay, and here's why. The CRO consolidation is more or less done ‒ the top 6 or 7 CRO's have emerged, and they control 70% of outsourced spending from sponsors. Many of the same financial investors that rolled up the CRO space are now rolling up the site space. I date the start of this trend to 2015, when PPD, through a related company, effectively acquired Radiant Research's sites and the next year, Synexus. But this trend still has a long way to go.
Most of these integrated site networks are looking for sites with $1 million in cash flow. Personally, I question how many sites of that scale are out there ‒ maybe somewhere in the low to mid-hundred's in the U.S., based on analysis I've seen. Eventually, some of these networks trying to grow in scale may have to explore other avenues for growth such as greenfielding new sites or growing smaller existing sites.
We hear that sponsors are still making site selection decisions based on individual PI experience, as opposed to the operational capabilities of the site or network. Is that the case?
There is wisdom in stressing PI experience for rare disease trials because of access to patients. Over time, if integrated site networks achieve size and scale, I think the industry could shift from a PI-centric perspective to more of a site-centric view.
Where do you think we're heading as an industry?
I think data transparency is where things will go and, at Devana Solutions, we want to help lead the way. The best analogy to gauge where the clinical trials industry is headed would be to look at the history of the financial sector. Back in the 50's, there were no standards for determining who was creditworthy. Bankers would come to people's homes, perform interviews and make subjective decisions based on your neighborhood and even the quality of your existing furniture. You can imagine all kinds of problems arising from such a process. Then the financial industry came up with FICO scores standing for the Fair Isaac Credit Organization after the co-founders. Now, every lending decision is driven off that more objective measure, a common standard. If you think about it, we're doing investigational research on real patients, and lives are at stake. But there is no standard or uniform measure around site performance. That's got to change, and I believe that will change.
Barry Lake is the CEO and co-founder of Devana Solutions, a business analytics, startup and metrics-capture solution for research sites and site networks. Prior to starting Devana, Barry ran a research site, where he personally experienced the frustrations of managing a complex pipeline of studies. Barry is a serial entrepreneur who has started and sold various companies in different industries but is presently focused on the clinical trials industry.
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