Why Cloud Makes Sense for TMF

May 7, 2013

  • eTMF Best Practices

The term Cloud has received a lot of attention over the past few years and rightly so. Cloud technologies offer real and specific advantages over more traditional computing models and these advantages align well with the needs of Trial Master File. In this article we will look at the origins of Cloud computing, explore the unique benefits the Cloud offers and how these benefits can be leveraged within the TMF landscape.

One of the primary drivers and perhaps largest presence that has given rise to the Cloud is Amazon. In addition to offering every item imaginable for online purchase, Amazon also offers a plethora of commercial cloud services. In fact, movie giant Netflix hosts their entire operation on Amazon’s cloud. From the website where you browse available movie titles to the streaming of the movies themselves to the backend office billing systems – all are Amazon based.

It’s interesting to examine the driving issue that gave rise to Amazon’s development of their Cloud services. As Amazon started to really grow, they noticed a disturbing trend – they found that they were paying for computer resources that went largely unused. During the day and early evening their servers were very active as customers eagerly shopped. But, overnight the servers sat virtually idle. This problem was compounded by having to scale up their operations for peak demand during the December holiday rush only to have those additional machines go unused the remainder of the year. This led to the idea of offering these unused computing cycles for rent to other companies. Perhaps companies in Asia could utilize these unused machines during the late night U.S. hours. Perhaps companies with other seasonal demand spikes could utilize machines outside of the Thanksgiving to New Year’s window. Cloud computing was born resulting in inexpensive processing available for rent and capable of dynamically scaling up and down to accommodate changing needs.

The sharing of computing resources and applications in a seamless and scalable way is what defines Cloud as a technology. The list below identifies the major characteristics of Cloud applications and how these may be leveraged within the TMF business environment.

  • Scalability & Performance – the ability to dynamically scale an application to handle spikes in demand is a fundamental feature of Cloud based systems. This pairs well with the dynamic volumes within TMF in which studies frequently start and stop, studies are extended to additional sites, and patient enrollment increases. The TMF Cloud can dynamically react and provide for increases and decreases in required volume and performance.
  • Accessibility – Cloud leverages browser based applications and distributed environments making the capabilities available anywhere and bringing the computing resources close to remote locations. This pairs well with the worldwide distribution of clinical trials where documents must be gathered and reviewed across the globe.
  • Flexibility – Cloud applications lend themselves to being called up on demand. The ability to self-provision new studies and sites on demand and eliminate delays and decrease cycle times is a huge benefit and can reduce the time to filing for studies on the critical path to product registration.
  • Reliability – Cloud applications are designed to be very reliable and highly available. System components are typically deployed in pairs such that if one component fails the partner component is immediately aware of the failed state and assumes operations. This ensures critical TMF functions remain up and available supporting around the clock operations.
  • Costs Savings – Perhaps the most popular aspect of Cloud is the ability to keep costs in check. Cloud applications tend to cost less because they can be securely leveraged across multiple customers with associated development and operating costs spread across a number of payers. This helps reduce the overall expense of running clinical trials.
  • Partner Networks – With the increased use of CROs, joint ventures, mergers and acquisitions as well as functional sourcing, trials are increasingly being executed by multiple partner companies. Often this leads to issues relating to whose technology to use and complexities of providing appropriate and effective access. Cloud based solutions are engineered to be multitenant applications which fully and mutually support the work and role of each partner.

As the TMF landscape continues to evolve and the associated business models and business relationships continue to morph and grow, the advantages and benefits of Cloud offerings become more pronounced.  Wingspan eTMF has been designed from the ground up to fully deliver on these promises of the Cloud.