What is the “Cloud” exactly? There seems to be some confusion in the industry with what the term “cloud” refers to as it can mean different things to different companies. The concept of cloud can be viewed as simply as hosting information on virtual servers through the internet or as complex as anything that is consumed outside the firewalls of the company. Before moving forward with a cloud strategy, it is critical to gain an understanding of what is meant by the term “cloud” and what fits the needs of your company.
The next question is a doozy. Now that you have an agreed upon definition of the “cloud” within your organization, how does it differ from just outsourcing infrastructure? The answer is data access. For example, if you outsource infrastructure to a CRO, chances are you have very stringent contracts regarding data access and no one else is using that system. Many cloud solutions however have countless users for one system. So your data is sitting right next to your competitors data? Yup, that’s a distinct possibility.
As discussions between various pharmaceutical companies, CROs and service providers began to heat up at CBI’s Cloud Seminar at ClinTech 2013, it became apparent that what’s keeping everyone up at night is maintaining control over data, especially when it comes to valuable R&D data. What were the top concerns of executives today BEFORE creating a cloud strategy? We outlined 5 considerations to discuss internally before signing the dotted line.
5 Key Points of Concern When Developing a Cloud Strategy:
1) You Should Always Have Access to the Data
Part of the benefit of the cloud is having access to real-time data to make critical decisions regarding trials. What if your real-time data isn’t refreshed often enough or you need to jump through hoops to get access? What should be “real-time” is nothing but, and you’re paying for that. And that’s just the basics. You also need to consider data access when a contract is terminated. How do you get your data back and how long will it take? Does it cost you every time you pull data? Do you have direct access? Here is a surprising one – Is the vendor using your data? Yes, this is a real concern and something that has happened to them according to one CRO. The bottom line – Not having clear expectations upfront on data access can be detrimental to your business.
2) Who is Responsible for Testing and Validating the System? Remember, the SPONSOR is Still Liable
It is no secret that the FDA requires that systems are tested and validated and that not doing so can lead to heavy fines. Just because your data is in the cloud doesn’t change the validation process in the eyes of the FDA. The sponsor is still liable and even if the validation is done at the vendor, the sponsor needs to have a handle on it. First, you need to decide who will do it. Then you need to create clear and appropriate business roles and processes, including changes. Sounds like a daunting task? Talk to your vendor and set (and monitor) expectations.
3) Pay as You Go Model? Just as Expensive if You Don’t Plan Integrations Upfront
A few options exist to pay for cloud solutions, including subscription-based and pay-as-you-go models. Why pay a subscription if you want to stay nimble and low on cost? Leaning towards pay-as-you-go? Read this first. When you purchase the service and plan to add new integrations as you need them, it can be very costly. You will need to pay for the infrastructure “build” for each integration rather than building it all upfront. Think about it this way. If you are building multiple additions to your house, are you going to pay the carpenter and electrician for their time twice or would you rather do it in one shot?
4) Vendor Community – Beware of the Low Barrier to Entry
Anyone can put information up on the internet, right? Not when it comes to precious R&D data. You need to do your due diligence to understand what you are getting from the vendor and have a deep understanding of the cost/risk balance of the solution you choose. Is it a community based solution or owned by one vendor? What happens once there are system upgrades? Thought among the industry thought leaders is that there is no one perfect solution right now and they are experiencing growing pains as pharma starts to gain interest in this area. Also, it is impossible for vendors to anticipate both the needs and challenges working in such a heavily regulated industry. Good solutions are out there, and they are making progress.
5) You Bought It, Now How Do You Make Sure Everyone Uses It?
Technology that isn’t used (properly or at all) is a wasted resource. How do you ensure internal adoption? Creating a change management strategy in concert with the release of your system is paramount to ensuring user acceptance and continual adoption. Clear communication between groups, departments and across the organization is necessary. Consistent training and oversight elements should also be addressed. And the blessing from the top can’t hurt either. Some companies have tied elements of the adoption to bonus structure, and sets expectations upfront by date of release, etc.
Strategy Development to Cloud Implementation
By focusing on the above things, you will be armed with key points in determining your company’s cloud strategy. Protect your data. Be compliant. Plan for the future. Find a vendor that meets your needs. Develop an internal implementation strategy. And save money!
Want to hear more about how leading pharmaceutical companies are moving R&D data to the cloud? Mark your calendar for ClinTech 2014, March 11-13, 2014 for exciting updates!