By Mark Vermette, Principal Consultant, Halloran

I’ve been watching software and service providers who support clinical research try to take advantage of the interest in the cloud. As a result, many either developed or are offering their products in a hosted or Software as a Service (SaaS) model. Admittedly, I’ve been skeptical about this. Part of that skepticism is regulatory compliance of these services. The healthier part of my reluctance with guiding researchers toward the cloud has just been lack of confidence in the execution by providers. It’s not just about the software. It’s about support, configuration, validation, security and all that.

What is obvious is that offering software in the cloud isn’t just hosting software that was previously offered for on-premise installation. Cloud software and service providers are getting over the lumps, some through thinking things through, others through rough experiences.

The cloud is here to stay and it is an excellent opportunity to adopt innovative technologies to speed clinical research with the proper due diligence. Here are five good reasons to consider cloud-based solutions, and considerations to look for in your research technology portfolio.

1. Reduced Capital Outlay (ideally)
   Part of the attraction of the cloud is a buy-what-I-need subscription model. Providers who have figured out what customers want have structured their licensing and hosting agreements so customers pay something for an up-front fee with a monthly or annual subscription. The cloud model isn’t attractive if it doesn’t come with the advantages of a progressive fee model.
2. Best-Practices Model (no, really)
   Managing different code bases and wildly different configurations kills the economic model of the cloud, for everyone. Are we all that different? Really? The fundamentals of adverse event processing, clinical trials management, electronic data capture, and so on are just not that different from one research organization to the next. What makes the difference is the richness of the application, integration capabilities, and the commitment of the provider to continue innovation. The best cloud-based software providers have figured out how to offer an acceptable, appropriate, best-practices suite of functionality on top of an innovative platform. Be wary of a potential partner who doesn’t strongly advise against customization and straying.
3. Reduced Operational Complexity
   When you really take the time to think about all the things you have to do to put a solution into production, it can be daunting. Add in the considerations that come with broader collaboration using these solutions. That extra effort includes issuing accounts and passwords to external users, network security, external user support, and all the steps and services required to securely and comfortably allow everyone in the stakeholder community to use and be supported for the solution. Using a good cloud-based solution, with the properly established support mechanisms relieves you of many of these considerations. Truth is, most research organizations and their technology teams are not set up to support external collaborators, and it creates a whole new set of requirements and costs. A cloud solution offered by a good provider is an excellent alternative.
4. Openness and Data Portability
   Over the years, one of the biggest barriers to electronic collaboration in clinical trials and research has been the difficulty to establish a technical framework and rules of ownership, use and severance. Openness and portability are the enemy of “stickiness” and solution dependence. I’ve been party to conversations over the years where it was impolite to discuss what happens if something goes wrong or how a partnership can construct a technical solution that is neutral and not “owned” by any one participant. The leading EDC solutions have become, by default, a model to look at. Although the contract for the EDC instance is owned by one of the collaborators, the application and data can be made accessible to all the participants, in real time in many cases. The solutions vary on form designers and technical tools, however adherence to data standards, reporting and integration tools make portability of the data a reality. Picking a solution is more about service, support and innovation, exactly as it should be.
5. You Can Be Partly Cloudy
   You can have a cloud solution fit within the rest of your roadmap and IT environment. You may want to consider this to test the cloud, or some things are just not going outside your data center. Cloud providers are primarily focused on improving their software and providing support services, with some accommodations being made with APIs and web services for integration. Up springs a new group of service providers, some from what used to be traditional implementers. Good cloud providers are encouraging these partnerships to make the solution the most valuable to their customers. In the end, you get a lower cost solution that still integrates with other solutions in your environment.

There are cloud-based solutions to solve a lot of headaches, from single sign-on, data storage, analytics, to complete applications. It just makes sense to pursue these with a clear set of requirements and the right due diligence. If you’re ruling out the cloud, or running behind in adoption, you’re likely spending more time and money on things that distract you from what you can do better.

Mark joined Halloran Consulting Group in 2015 with over 25 years of experience delivering technology, consulting services, and software in the life sciences industry. He has led system implementations for Clinical Trials Management Systems (CTMS), Electronic Data Capture systems (EDC), safety systems, data warehouses, content management systems, and analytics and reporting platforms.