By Deb Borfitz
June 1, 2009 | An increasing number of the top life science companies are considering a switch from the outright acquisition and customization of e-clinical technologies to establishing and accessing “clinical clouds.” Indeed, it may be the only sensible way to access needed software and information as they engage in more collaborations, alliances, and partnerships to weather the “perfect storm of unprecedented challenges” bearing down on their collective bottom line, says Paul Papas, the Americas life sciences leader for IBM Global Business Services.
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| Paul Papas |
Historically, most large pharmaceutical firms have run fully integrated vertical business models, doing all they can in-house and “choosing to selectively outsource where appropriate,” says Stuart Henderson, IBM’s Americas life sciences research and development leader. But many are moving to a network business model where they share risks, rewards, financing, and resources with a portfolio of partners to, among other things, develop and commercialize drugs. As companies do less within their four walls and seek to reduce the time and cost of clinical development, the demand for hosted, fully integrated, end-to-end clinical solutions will rise because sharing an integrated platform is cheaper, less time consuming, and more supportive of a networked business model than the alternative.The enabler of all this is cloud computing, an Internet-based model wherein a broad range of applications can be tapped from just about anywhere. Users needn’t know anything about the technology infrastructure in the cloud that supports them. They pay cloud computing service providers like IBM and Amazon only for the resources they need and use.
“Building a smarter clinical cloud will enable collaboration, transparency, and access to real-time information wherever it is created,” says Papas. According to IBM, a “smarter” clinical cloud consists of ten core capabilities: multi-tenant security, file sharing, data sharing, help and support, collaboration, analytics, compliance, clinical application suite, process integration and orchestration, and infrastructure.
Clinical cloud computing is certainly more economical for companies than buying licenses for separate electronic data capture (EDC), clinical trial management (CTM), and information management systems, integrating them internally, and then redundantly paying for the same services whenever they use a clinical research organization, says Henderson.
The FDA already trusts external servers when clinical trial data is sent by email from labs to investigators and from investigators to sponsors, says FDA spokesperson Crystal Rice. But if the data is archived using cloud computing, sponsors will have to convince the agency that there are adequate “write protection” safeguards to prevent tampering. The FDA would be particularly interested in data security measures if the cloud computing service provider has other “sensitive users” such as insurance companies and banks. “The agency might [also want to] check for assurance that investigator records correspond with the data in the cloud repository.”
IBM predicts that life science companies will “flip” to buying technology in a cloud-provisioned way within no more than three to five years. “The situation will be less about which products they use to do EDC or CTM,” says Papas. “The majority of talented clinical IT resources now focused on operational efforts will instead be focused on the science of analytics.”
So what will companies do with the millions of dollars of technology they have already invested in? “There are multiple options and much depends on the investment lifecycle for each clinical application for each client,” says Papas. “IBM’s approach is to enable a phasing to cloud computing where a client uses a combination of their in-house applications and the applications available as part of the cloud solution.”
The move to cloud computing will essentially force companies to agree not just on how they will collect and exchange clinical data, but also how they will manage and warehouse it, says Henderson. “What companies increasingly agree on is that the differentiation they bring is not in the applications they use to execute studies, but the study design, the assets being progressed through the pipeline, and their relationships with clinical investigators.”
When done right, Papas says, a clinical cloud will facilitate company-specific variations via configuration rather than customization. “Companies will have to realize and accept that most customizations are costly and do not provide differentiation.”