eClinical 2011: Remedies for the Clinical Trials Machine
The strategist Nick Giannasi (Oracle)
February 7, 2011 | Nicholas Giannasi is VP Life Sciences Product Strategy, sitting within Oracle’s Health Sciences global business unit, covering clinical development and safety. He was previously head of the informatics business at GE Healthcare, during which time he spoke at length to Bio•IT World (see, “Bringing Good Things to Informatics”, Bio•IT World, Sept 2005). At Oracle, Giannasi has responsibility for the requirements, design, and direction of some 46 eClinical and safety products, including the recently acquired Phase Forward. Giannasi offered Bio•IT World chief editor Kevin Davies an overview of Oracle’s clinical offerings and aspirations, as well as steps to guard against complacency.
Nick, could you tell us about Oracle’s ever-expanding clinical product portfolio?
Giannasi: If you think of research on the left and health care on the right, we’re exactly in the middle. The combined portfolio of the health sciences business unit has four product categories:
One is broadly defined as eClinical, including classical EDC with InForm, which was acquired from Phase Forward, and Oracle Remote Data Capture; Oracle Clinical and Phase Forward’s Clintrial; technologies around patient diaries—we have a late phase and ePRO solution, OutcomeLogix. We have a Phase I clinic automation solution, LabPas; and an IRT solution (IVRS/IWRS). We have Phase Forward’s Central Designer to set up a study within and across those different data capture technologies.
In clinical warehousing, we have couple of products—Phase Forward’s Clinical Development Center and Oracle Life Sciences Data Hub for aggregation and discrepancy management, control of a SAS or R stats environment. It provides centralized warehousing for any kind of analysis across clinical development and beyond.
We term the third area operational planning, tracking and management. It includes Oracle’s Siebel Clinical Trial Management System (CTMS) and Oracle Clinical Development Analytics, which is an enterprise-level, business intelligence tool that goes across studies and across technologies. It’s really focused on operational performance or key performance indicators, it has role-based views for executives, managers, CRAs, and site staff. It gives a 360-degree view of a study’s progress across trials, but also, importantly, of the different constituents involved in a trial.
Safety/Pharmacovigilance is the fourth area. In terms of classic adverse events case processing, we have a number of solutions: Argus, Oracle AERS, and Empirica Trace, which is the case processing side. We also have signal detection on studies and post-marketing data, Empirica Study and Empirica Signal [both originally developed by Lincoln Technologies, later acquired by Phase Forward]. I’m delighted to have Chan Russell (Lincoln Technologies’ founder) on my team. We have a new product called Topic Tracker, which enables life cycle management of signal detection. Signal detection is moving out of a cottage industry into more mainstream. It needs to be tracked, who did what and when, in a classic audit way.
So, within those four broad categories, it’s a huge menu of products, and that’s only the life sciences part of our health sciences business. It’s an unparalleled footprint. We’re trying to be as complete as possible supporting end-to-end business processes. We obviously don’t have some areas, because we can’t have everything, but we have a large portion.
How active are you in the standards arena?
Oracle is a leader in many standards bodies. Importantly, we’re very active now in CDISC, HL7 and BRIDGE. We hope to work with third parties or in-house systems. But, clinical development isn’t done in isolation; there are huge benefits to leveraging health record data and information. We’re the only IT company involved in PACeR, with Pfizer, Merck, Quintiles and about 19 organizations in total. We’re leveraging health information from New York state into clinical development and creating a sustainable business model for both the providers as well as pharma, and hopefully bringing some benefits to patients, as well.
How do the assets of Phase Forward fit into Oracle’s eClinical portfolio?
The synergies are extremely good. Phase Forward has a Phase I clinic automation product, which Oracle never had before; a very good IRT solution, which we didn’t have before; and a late phase and ePRO solution, which we also didn’t have before. Phase Forward also brought the market-leading EDC system in InForm.
On the safety side, Oracle had the market-leading Argus products, and Phase Forward had the leading signal detection products. That’s very complementary. On the data warehousing front, Phase Forward had a clinical development center focusing on discrepancy management and the statistical control environment, putting a compliance framework around SAS and R.
Oracle had a broad Life Science Data Hub, a broad infrastructure without those functional domains. So that fit is very good, as well. Finally, Oracle has Clinical Development Analytics. It gives a much more complete picture.
One of the main things we’re doing is integrating EDC to CTMS for some of those activities, and EDC to safety for exchanging adverse event information. We also have integrations from EDC to IRT, and IRT integrations to CTMS. The focus of these integrations is on users, the user experience, and the business process they’re trying to achieve. It should be people centric, not systems centric.
There’s another rationale for the acquisition—the Oracle products were generally classic software products implemented on a client’s site. Phase Forward had most of its business around SaaS (software-as-a-service). If you think about the trends in the sponsor industry and academic medical centers, it’s a mixture of ‘on premise’ or cloud or SaaS deployments. You need some understanding and experience on both sides. People don’t just move overnight to SaaS or stay on-premise. That mixed bag of deployment skills is very complementary.
Why do you keep two overlapping EDC systems, unless you’re contemplating phasing one out?
We’re not looking to phase any products out. We’ve done over 80+ acquisitions, and we get asked this all the time. We intend to leverage Oracle’s Applications Unlimited strategy, which was initially announced around the PeopleSoft acquisition.
The Applications Unlimited strategy is also what we used when we acquired RelSys, and we’re following that same policy with the Phase Forward acquisition. So that sounds good, but people ask, ‘Isn’t it a bit crazy?’ The evidence shows we’ve done it for 6-7 years, and we have software at the applications level, the database level, and the middleware level…Oracle’s middleware and database give us a huge economic and technical advantage versus a [smaller] independent software company that doesn’t have the middleware or technology. So, we can afford to maintain overlapping products.
Do you see growth in the EDC market and much upside for getting trials to use EDC?
We continue to see a steady increase in EDC, which is good. But the industry isn’t taking up EDC in isolation, because that’s only addressing one part of the solution. The industry is looking much more holistically at the integration across the whole of eClinical development space and safety. We’re seeing more sponsors focusing on the whole ecosystem.
If you have an inevitable change in protocol, you have to have a change in an EDC system. That study has to be altered in the EDC system. However, if you have a change in the protocol, you need a change in randomization, the supply, the CTMS, and the analytics.
We see people looking at that much more holistically, but we see the benefits not just focusing on EDC but on having a more integrated and simplified electronic environment. If you look at companies like Novartis, GSK, sanofi-aventis, and Quintiles, they have various initiatives that simplify their environment and focus on an end result.
Many years ago, people were excited about improvements in EDC, but studies show that the data quality using EDC doesn’t necessarily increase as much as people would have liked. Hopefully, some studies will come out soon that show the benefits of a more holistic approach.
What are Oracle’s offerings in the pharmacovigilance space?
One side is the safety and reporting to the authorities. We have Argus Safety, the market-leading products, and we’re making improvements there. On the more innovative proactive pharmacovigilance side, we have a product called Empirica Signal, which we co-developed with the FDA (and GSK). It’s the leading tool for detecting signals and issues both in clinical trial data and post-marketing data. We also have a collaboration with the Department of Defense working on very large health care data sets, involving about 12 million patients...We have fantastic people in that area, including Chan Russell and Bill Dumouchel, our chief statistician who invented one of the major algorithms in this space.
How will Oracle’s product suite benefit clinical trial research in the coming years?
We think the eClinical bucket of Phase I, EDC, and the set up and design of studies will provide an operational efficiency. It doesn’t necessarily help with the quality of the content, but it can help sponsors work more efficiently and cost effectively. In terms of finding novel therapeutics, we think our warehousing environment to provide an aggregation source to leverage data not only to look at operation efficiencies but also to mine in a more holistic manner, can give insights to produce novel therapeutics. Those two can basically give better insight and save money.
We also think our safety solutions facilitate a way for sponsors to get an earlier look throughout the life cycle of compounds. That’s really important. As an IT company, we can provide operational efficiencies and an environment to help leverage the data mining aspects.
Safety is a huge issue, and a change is brewing in the health care world. We should be able to shorten cycles in capturing safety data, as well. If we can compress the time and cost it takes to capture data and enroll patients, it should give the industry more access to richer, cleaner data and the foundation to find novel therapeutics more quickly and cheaply. We can only be a bit part player in that, but we’ve got a reasonable role to play, to let the scientific and medical minds apply their brilliance and we provide the technologies to enable that. •
This article also appeared in the January-February 2011 issue of Bio-IT World Magazine. Subscriptions are free for qualifying individuals. Apply today.