Defining the Clinical Cloud The term “eClinical" was jargon that the pharmaceutical industry used over the last decade, without ever agreeing on its definition. Similarly, the term “cloud" has become the latest must-have descriptor for all kinds of technologies, across virtually every business sector. The scope of capabilities encompassed by each or both of these terms as they are used to describe clinical research is diverse and broad, ranging from simply applying technology to older paper-based clinical trial processes, all the way to defining the future state of clinical development. Unfortunately, the lack of strict — or even consistent — criteria for use of terms like these has led the industry into a lackadaisical way of looking at development and innovation. A range of companies — from sponsors to CROs to hardware and software vendors to systems integrators — have backed into whatever definition of “eClinical" or “cloud" was most convenient for them. Instead of shoehorning whatever processes, products or services people have into a “cloud offering," our industry needs to strive for the true spirit and value at the core of the cloud: Leveraging the state-of-the-art in computational environments to reinvent the way people interact with information, in a way that improves business performance. In the case of the clinical cloud, the information people interact with is well-defined, and inherently obvious. It’s the clinical and operational transactional data we use to plan and execute trials. Defining the Cloud The more problematic definitions are those related to the state-of-the-art in computational environments and real-world improvement of business performance. For example, Medidata uses Google Apps for its approximately 900 employees. The Roche Group is rolling it out for its 90,000 global employees. Those numbers are insignificant compared to the tens of millions of Google Apps users around the world. By aggregating the needs of so many users, Google has created a cloud solution that allows all users to benefit from high service levels and continued innovation. Taking the same software a company could have run for themselves and putting it in someone else’s data center therefore is not implementing the cloud. Nor is the fact that an application is web-based sufficient qualification. Scale and scalability, wide (if not universal) applicability and tangible business value beyond the established norm for a function need to be met before the term is used. Adding Value Through ­Technology To the point of tangible business value, one of the issues many “eClinical" implementations have historically encountered is that they simply transitioned legacy processes from paper or client-server systems to the web, without taking full advantage of the possibilities that new and different infrastructure can offer in regards to automation, elimination of steps or making serial process steps things that can be done in parallel. The ultimate purpose of adopting any technology should be to add value: increase efficiency, create new visibility and decision making capabilities, lower risk, increase quality and create competitive advantage for the organizations adopting it. Working in an eClinical environment should let you look at data differently, provide real-time feedback, and help accelerate time-to-market for the therapies that our industry exists to deliver to patients. Merely putting paper-based processes on a computer screen isn’t enough to achieve that. Allowing clinical and operational information to be aggregated and managed by all stakeholders in a trial in a way that allows that study team to outperform how it would run without the systems enabling it is the right goal. In that pure sense, the clinical cloud is a very powerful idea. Life science professionals can now seek out technologies that minimize — or eliminate — sponsors or CROs concerns about availability, scalability, integrations, and implementation cycles that plague so many clinical and corporate systems from the past. Clinical cloud solutions can match and grow to meet user needs because of the inherent scale in which they are delivered. Every stakeholder in a trial working on the clinical cloud, all the way from the clinical scientists to subjects, should benefit from the computational environment. Whether that amounts to better decision making, higher job performance or being less likely to be exposed to an ineffective dose of a test material, the technology should enable a better study experience. Further, users of cloud technologies should be able to embrace improvements in the technologies they use on an ongoing basis. For decades, our industry has suffered through staccato technology cycles of heavy implementations, low-value yet highly expensive manual approaches to computer systems validation and waiting for big-bang system upgrades. True cloud technologies take a completely different approach and incrementally add capabilities that enable process improvements, meaning both user experience and study performance increase over time, rather than stay static. We have come a long way from everyone in the industry working on paper or building heavy-client — clinical research is finally moving to the web. But our work can’t stop there. As an industry on the cutting edge of research, whose role impacts millions of lives and the global healthcare economy, it’s important to make sure our technologies are equal to, if not superior to, those in other industries. That is why we need the clinical cloud. Glen de Vries, President, Medidata Solutions Worldwide Medidata Solutions Worldwide is a leading global provider of cloud-based clinical ­development solutions that enhance the ­efficiency of customers’ clinical trials. { For more information, visit mdsol.com.

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