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Demystifying Clinical Trial Management


PharmaVigilant is on a quest to make CTMS crystal-ball clear.

By Kevin Davies

January 20, 2010 | James DeSanti, CEO of Westborough, Mass.-based PharmaVigilant, founded the company in 2005 to answer some of pharma’s perpetual clinical problems. DeSanti came through the sales and marketing ranks at Johnson & Johnson before becoming president of Walsh Americas, a large data company. From there, he transitioned to Phase Forward and R&D in 1999, where he led the commercialization effort, ramping up sales to more than $60 million in 2002 before leaving to start PharmaVigilant. Kevin Davies spoke with DeSanti about PharmaVigilant’s progress and offerings.

Bio•IT World: Jim, what are the chief assets of PharmaVigilant?
DeSanti: The story starts with Omnicom, a very large global advertising conglomerate with close to $10 billion in annual turnover. Omnicom decided it had dealt with so many product launches, it could use some software for its pharma customers. They commissioned Cognizant to build a scalable system—called InSpire—to service their own internal companies. That effort took 3 years and 33 engineers at Cognizant to build it. It was very scalable to take on very high volume studies. We brought over the InSpire EDC software and our engineers took it to the next level. We’ve implemented our suite of products with more than 25 clients, predominantly in biotech companies, and are now implementing with Tier 1 and Tier 2 pharma companies. That’s where we are today.

What’s special about PharmaVigilant’s software suite?
Our largest study was 180,000 patients that we’ve completed and other studies in the 70,000 patient range. The software can handle Phase I-IV. The base product, InSpire, incorporates within the EDC segment randomization, auto-coding, safety systems, etc., and with that base system it has components of complex and simple edit checks, versioning, etc. Everything you’d run for a submission trial is in there. We also have very substantial trial masterfile system, the only data warehouse commercially available that can handle multi-trial analysis. And on top of that, we have remote source document verification software, so we’re addressing the whole monitoring issue as well.

Who are your key clients?
We have pharmas—tier 1 clients—as well as biotech clients (tiers 2 and 3). All our current clients are industrial. You’ll see our client base grow from sponsors to include CROs and academic medical organizations….

If you’re looking to do a very large trial, you need that scalability. Speed is very important. You can run small trials just as easily as big ones. You can drive a Porsche at 10 mph just as easily as 150 mph.

So you’re the Porsche of clinical trial software?
I can’t wait to show it to you! On the data warehouse side of the equation, it’s blindingly fast. Most of the trials are not very large in our industry. If you’re running trials with a few hundred patients, it’s very, very fast. The rest of the system is fast too, but where we get tremendous feedback is the warehouse. Whatever you put into the warehouse you can view, and you can control who sees what data. We have 26 clients right now. Sponsors typically deploy our EDC system, including both the warehouse and eTMF; however since the products are modules, they can be deployed separately and/or with other systems. Our remote monitoring module has been utilized on Phase II and pivotal Phase III trials. It can be deployed with our EDC system, or the sponsors’ system of choice.

Are you web-based EDC and have you looked at other EDC technologies?
We are. We’ve seen tablets and digital pens around the market for years. We just haven’t seen the adoption of it yet. If we see the market switch, then like every other technology company, we’ll come out with offerings.

Do you handle adaptive trial designs?
Adaptive is what we call versioning. When you deal with adaptive designs, you need a robust building tool and you have to have the ability to handle unlimited versions. Adaptive design is mostly used for oncology studies—it has to do with the ability to branch out the study, going into many different types of cohorts as you go through the study. From the adaptive viewpoint, you also need to seamlessly handle unlimited versions, because you’ll have IRBs, countries, all these balls in the air… We’re also seeing adaptive in certain therapeutic drugs where indications start to open up.

What are some of the key benefits of InSpire for your clients?
Right now we’re very involved with tier 1 pharma clients on remote monitoring. Several pilots are underway. We’ve got attention because of cost savings—that’s one thing we’re seeing. Remote monitoring is taking source document verification and doing it remotely. Up to 50% savings are possible. These are not millions-of-dollars savings, they’re tens-of-millions-of-dollars savings. And they’re hard savings—you can quantify and institutionalize it. We’re also seeing remote monitoring: We’re talking about increasing monitoring from 5-10 to 100%. So it’s reduction of costs and reduction of risk.

Aside from lowering costs and risks, does InSpire also help expedite clinical trials?
Yes. We build and deploy on average in 4 weeks (others often take 6-8 weeks). We used dedicated teams, others use matrix teams. And I can lock my eTMF in at the same time as EDC. On paper, that could be months. Now I have both things happening at the same time. Also, I’m monitoring as I go, so there isn’t a lot of monitoring at the end of the study. We can close out a lot faster.

Why are you starting now to engage with the e-clinical community?
We’re ready now. We have everything in place to start the process of really getting the market share that’s attainable to us. Because we have all the pieces in place, and results in place too—that’s important. On remote source monitoring, for example, we went ahead and deployed that with clients on Phase II and III so we had metrics. When we took it to market, we can show the software and results we’ve gained. That’s our planned approach to coming out now—having everything in place so the solution is ready for the entire industry.

What do you have in mind for 2010?
We’ll continue to add customers and market share as any company could and should. We’ll continue to be aggressive. We’re ready to prove our product. The needs of pharma are insatiable! Having come from pharma, I know they buy in a certain way. Products and services need to be tied down and proven, something they can really believe in. Then they start the process of product and vendor conversion.

We see tremendous opportunities in the top ten pharma. When we go in, we present the entire picture. It’s interesting—we were going to cherry pick, but the clients say we want to see the other stuff. We’re showing the entire suite. Just as the current market leaders displaced paper, new technologies will replace existing ones, as the increasing demands of the sponsors inevitably force change.

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