August 3, 2016 | Earlier this summer, Oracle announced that Pfizer had selected the company’s InForm Cloud Service and the Siebel Clinical Trial Management and Monitoring Cloud Service to help manage and monitor its more than 300 clinical trials a year. But Oracle Health Sciences is also making a push into smaller markets, intent on convincing customers that their offerings are “right-sized” for all kinds of sponsors.

Clinical Informatics News editor Allison Proffitt spoke with Steve Rosenberg, senior vice president and general manager, Oracle Health Sciences, about the company’s work with Pfizer and how it serves much smaller companies as well. What follows is a portion of that transcript.

Clinical Informatics News: Steve, tell me about this announcement with Pfizer.

Steve Rosenberg: Pfizer went through this incredible evaluation of their business models with the way they deal with partners as well as what they have to do to make that ecosystem more efficient and they decided they would need to standardize across a platform for clinical research from the beginning to the end, really, so from CTMS to warehousing. They did an exhaustive search evaluation and they elected our platform from beginning to end working with Accenture for implementation, so that was big.

I’m sure you went through a pretty aggressive RFP with Pfizer. Tell me a little bit more about the process and what you are offering. Are you offering them anything off-the-shelf or is everything custom?

It’s all off the shelf. There’s no product that we’re building custom for them. Our CTMS product we sell off the shelf. Of course the implementation will be configured for them, but it’s based on SQL CTMS that’s been around for a while been upgraded over the years. They licensed our InForm product, which is the tool to build clinical trials. There’s a design product that goes along with InForm where you build library assets and you build your forms and your rules and your hierarchies and your user interface, the paths—all that kind of stuff—and that gets put into Central Designer that gets used across your clinical trials. They’re planning on building all these standards within that tool and then telling their partners they have to use all that standard. They already were a giant Argus customer, so they do all their safety reporting and adjudication globally through our Argus product, which is our safety product.

They licensed our Data Management Workbench product as well as our Life Science Hub product and they’ve hired Accenture to stand this up in the Accenture Life Science Cloud. What Accenture does is they take our products, they wrap a bunch of services in what they call accelerators around them, which is just an out-of-the-box implementation kind of thing. It’s not really new product development. If you were to implement it on your own, you’d do the same things, but Pfizer—they’ve worked with Accenture for a million years—they’ve worked with Accenture to put the backend in and that’s where the data leaves the clinical trial and goes for data management and then warehousing and then submission. They license those products from us, too. None of this stuff is custom. The implementation, obviously, is specific to Pfizer, and this one is probably more complicated than most just because of the number of trials, the varied therapeutic classes they work in. They probably have one of the more diverse pipelines in the industry. And the fact that they work heavily with CRO partners. They outsource most of their trial activities. They first signed up Parexel and ICON and then they added PPD maybe a year and a half ago, and I just saw a press release at DIA that they added InVentiv, so now they have four to handle their pipeline.

On the opposite side of the spectrum, Oracle Health Science is also working on expanding offerings to smaller sponsors. Tell me about that. 

We have been focusing for a couple years now on the emerging markets within clinical research. If you look, there’s some really exciting drugs being developed… but what people don’t recognize is that there’s a ton of really great research, small population diseases, even larger population diseases happening in the smaller companies. We have focused a lot of attention on those guys, both from a sales perspective, as well as with our product offerings, the way that we right-size them for those markets. In the past year we’ve added 94 new logos. One is Pfizer. I’m not going to say all of the [other] 93 are small, but a lot of those are the emerging markets, just small CROs or large CROs. We see so much activity in that part of the market in terms of advanced research, clinical trial activity, innovation, mostly science-oriented. We’re really excited about the success we’ve had there. Normally those guys would go, “Oracle, they’re too big for us,” so we’ve really right-sized our offering so they can take advantage of the same industrial strength capabilities that we offer the Mercks and Lillys and Pfizers, so pretty excited.

How are your offerings for smaller customers different from what you offer Pfizer?      

In the smaller markets, what we’re selling there is the ability to stand up a trial in a short period of time reliably, with high quality, and industrial strength regulatory rigor for the emerging world. So they don’t have to go to an OmniComm or a little tiny eTrial or DATATRAK and get sub-standard products, because the pricing and willingness. We actually have a whole business of focus around that. Pfizer was a big RFP process, tons of meetings, workshops—you know with these things, it goes on for a lifetime—versus, ‘Hi, I have a trial with the first patient in three months that we’re beginning to sign up sites. Can you stand it up for me at three levels?’ That’s that other market; there’s no big RFP process. There’s pricing, there’s commitment of timeframes, it’s a whole different cycle.

You said emerging markets; where are we talking?

If you were to look at the market, they’re mostly small biotechs that have significant funding or one or two drugs in Phase 3, and that’s kind of why you look at the market. Most of them, I think 80% of them, live in the US. I don’t know if that’s by design or just by environment, but then there’s a bunch of them that are in Europe. The rest of them are pretty much in Europe. We’re starting to see more business in Korea and China. There’s some companies and CROs emerging out of there, so we’re starting to see activity in APAC [the Asia Pacific region], but that’s a different kind of thing.