Achieving growth and profitability in today’s pharmaceutical industry means leveraging one of your most important assets — data.”
You see statements like this all the time. However, Big Data’s move into life science and R&D is progressing in an uneven and stutter-step way. Many in the industry understand that there are incredible possibilities — predictive modeling to identify new potential molecule candidates, collaborative efforts between researchers, academia, CROs and providers, enrolling patients in clinical trials with significantly more granularity at the fingertips of study sponsors.

But in the traditional manner of Big Pharma, silos and committees are addressing the Big Data questions agonizingly slowly. So, perhaps it is the perfect time for a frank discussion on how Contract Research Organizations (CROs) can catapult to the front of the data analytics pack and, dare we say, lead the way?

Impossible? Not if you break the data conversation into three simple steps for your CRO/CMO organization and use this simple framework to energize your management team towards a goal of developing a data analytics strategy. Let’s frame the discussion around Volume, Velocity and Variety.

Volume
We often hear that the amount of data generated is increasing exponentially. For an example, see Figure 1:

The traditional CRO is in command of a mountain of data; studies begin with a large amount of data in the form of clinical study participants, or animals and accompanying veterinary data, and end with even more data — the results of the study. This data-stream can include:

• Clinical trial results
• Patient enrollment details offered through variety of sources (social media, for example)
• Oncology and toxicology results
• Veterinary data from animal testing

Often between 10 and 30 studies per year are undertaken for a particular client. Ergo, a lot of data!
The data that is communicated between CROs and their pharma or medical device clients is not always translated well into the legacy information systems of Big Pharma. Often, CROs do not deliver results until after the study is complete, a practice that has been normal procedure for, well, forever. Often this extremely valuable information is still being transmitted in 100+ page PDF reports at the end of a study, although today many CRO have portals available, where principal investigative client teams can go and access data (“pull” data).

Begin today to consider how to rejuvenate your data interaction with your customer base.

We will focus on the opportunities inside Big Data to differentiate your CRO organization in the market. The Volume, Velocity and Variety of data that moves between a CRO and its clients have great potential for making the CRO a preferred partner. Consider these steps towards offering a more data-literate partnership.

Velocity
Pharma wants its data faster. Clients want personalized data and realtime data (and meta-data), and they would ideally like to be able to dig into the details at any point during the study course. After all, there are tremendous advantages to being able to call off a study, mid-stream, if the results are not what was expected. First steps to a new data information feature would have the CRO offering interim study results. Perhaps half-way or even every week interim reporting would be a big step for some organizations, but although this feature can move your organization into the new age of data, it still implies a “pull” system, where your client needs to go into your portal and “pull” those interim reports.

A savvy CRO can feed Big Pharma’s appetite for a Big Data win by offering a live data interface, where the data is fed simultaneously (or nearly simultaneously) into both the CRO data repository and client systems.

A True Differentiator
A CRO would now have the ability to show added value to pharma clients, by offering data connectivity that is truly interactive and can move beyond the status quo, to allow clients to gain insights because they are seeing data in real time. You can showcase a data system that does not require your client’s PI (principal investigator) to go in and pull the data manually, or require them to create an interface to go get their data, or run a protocol to get a report! Live data-feed over a Virtual Private Network (VPN) is the goal. By feeding a continuous stream of cleansed data in a standard format like SEND, CDISC or XML directly into systems that provide visibility and even alerts, the CRO enables the client to become more agile and informed.

Now that’s some tech talk, but what is really being delivered is data with a “no-limits” frequency of access that allows a pharma client to react earlier, drawing insight from ongoing study information and potentially save money, and make safer medicines, more quickly. Volume and velocity. The right information in the right format, in the decision window, when the decision needs to be made. Liver indicators not as positive as you had hoped? Now, with data access in real time, pharma can cut a study short. Indicators excellent? A larger population study is obvious as a next step? Start earlier, when the data shows the possibility.

Joseph Solfaro, chief information officer, inVentiv Health, remarked, “At inVentiv Health Clinical, we have been focused on the real possibilities offered by data analytics for several years now. We become true partners with our clients on many levels — but the ability to offer clients the insights generated from the data that is developed here, truly offers added value, and our repeat business is most definitely higher because of this.”

The Blue Puzzle Pieces First? Sure.
Back to volume for a minute. Once you open up the data systems to allow everyone on both sides of the aisle access, wouldn’t it make sense to ensure that the “right data” is available, not just all the data? Think of a puzzle — many people collect the edge pieces first, or sort all the blue pieces into a pile to allow completion of the blue sky, don’t they? People don’t think the same way when it comes to accessing information, but the newest data analytics systems allow this type of personalized access, so one PI can sort out all the “blue pieces” he needs first, while his team leaders can drill down to access the liver reactivity details.

Volume, Velocity . . . and Variety
When your CRO executive leadership team gets together to discuss upgrading your data systems, dare to go a little bit further. Consider being one of the first CROs to offer Analytics As A Service, or AAAS.

CROs often conduct dozens of studies for a particular client. Again, lots of information, but you have the data! So, why can’t CROs go beyond just delivering the data . . . and provide tools so the pharma PI can visualize and mine the data using tools provided by the CRO. Or perhaps a CRO could visualize and mine the data as an added service for the client! It is possible right now. You can develop a data system that looks across different studies for a particular client, and “sees” trends, looks for unknown parallels between previously un-compared studies and sees possibilities to inform an upcoming study. You have the data! And that data can become an asset for your organization. Cleanse it, analyze it, find the tidbits of insight and sell it back — as an added service.
Provide information; don’t just do the studies. Use IT to enable your client’s portfolio management. You’ve already done the thinking. It is not about the data itself (Volume), it’s about the delivery format and how frequently you make the data available, how fast (Velocity), and about the Variety of data insights you can provide your clients.

Long-term customer relationships are built on how well you over deliver, or add value in a business relationship. Learning how to add value reduces competitive vulnerability and enhances your strength with customers. If you can use information that you already have (data) and deliver insight, using AAAS, you are adding a service that may be tough to match.

How To Get Started
So, what are some first steps? Turning to a legacy systems integrator may not be your best path forward. They often don’t know the tools and techniques of enterprise data management or capabilities and limitations of the various data exploration, modeling and presentation vendors. Find what we call an agnostic, objective data analytics company that can take you through some seemingly simple steps, which can actually take an organization some time to implement. This is not a 90-day bolt-on strategy. Plan on one to two years of implementation, because the cleansing and aggregation of your own data is the most difficult step for many organizations, and understanding all your client’s data requirements will take time.

First steps will usually involve aggregating your existing data in a repository and mandating that your organization enter the data consistently to maintain its “cleanliness.” As inVentiv’s Mr. Solfaro maintains, “It takes constant vigilance on our part to maintain and upgrade our security access and the level of insight we can offer our clients, but we recognize that this is highly appreciated and is a measurable differentiator in the market for inVentiv Health Clinical.”

Presumably, the process of moving towards a premier data analytics offering would start simply. A canvass of what you collect, how many clients you serve at one time, how many clients you would like to service, what system you have and how your organization aligns its information would take the most time, and then the process would move more swiftly, into developing and installing the accessibility features that will be so attractive to your client base. Multi-tenancy systems for your multiple clients and the security features that secure the walls between different client data sets are issues that are common to every project.

Whether you are a large global CRO/CMO or quite small, data can be collected more effectively inside your organization and presented to your clients as part of a coherent, client-centric data sharing strategy. 

Eight Steps to Your New Data Analytics Strategy 1. Make IT and Data Analytics our 2014-2015 priority Your customer service? Improved. Your sales team — vetted and successful at bringing in prospects. What’s the next frontier? Data! Offer data that yield insight — in ways your Big Pharma clients could not have foreseen — and you will have a client for quite some time. 2. Assume Big Pharma is not nimble The life sciences industry is talking about Big Data and data analytics; the conversation is everywhere. But in most cases, your organization can be more nimble than Big Pharma and in several months can develop a new data system that will be much more interactive and attractive to pharma clients — with all the security of a multi-tenancy system. 3. Tie up your client relationship Offering services that clients cannot duplicate is a way to tie your clients closer to you. Data offered live — at interim stages — will save your clients money, by stopping a study earlier when results are not coming in or a particular side effect is recognized, and a new study must be developed. Yes, you may have to deal with shortened studies, but the credibility gained by offering the data in a timely manner will be invaluable. 4. Leave the competition behind Recognize that you have an opportunity to differentiate yourself versus competitors. More than any other investment, investing in developing data analytics and taking hold of this new data strategy will set you apart. 5. How to talk to Big Pharma IT You don’t have to! Or at least, not too often. What we are discussing is an objective, agnostic data system that is not tied to an Oracle, an SAP, a Microsoft system, but sits above all that. The change will come from within your own CRO and involves ensuring that your data systems will be compatible with whatever system your clients use, because these solutions sit “on top,” or above the legacy systems of your clients. 6. Include the opportunity cost in your cost/return analysis Can you get a higher margin the next time you re-negotiate a contract with your pharma clients if you have a new data analytics offering? Absolutely. Take this into account when you consider the next step on your data journey. 7. Dream and get clients to dream with you Get your pharma clients to breath a sigh of “possibilities yet unseen”— get them addicted to the data analytics that can come from analyzing data across cross-studies! 8. Think seriously about AAAS – Analytics As A Service The ability to offer insights and see tie-ins between studies done years apart, and then offering that to your clients as an add-on service can make you, and your clients, better portfolio managers. Because of tools you can offer, your pharma and medical device clients become more selective about which new therapies and molecules they develop, and more innovative about the manner in which they are evaluated for the drug pipeline.

---

George Brunner is chief technical officer of Acumen Analytics, a performance management and analytics consulting firm that works with Fortune 1000 businesses to optimizing their performance and create competitive advantage through data driven insights and predictions.. He can be reached at GBrunner@Acumen-Analytics.com.