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Welcome to the Clinical Cloud – Are You Ready?



By Jennifer Goldsmith, Veeva Systems 
 
February 19, 2014 | Contributed Commentary | Market research studies trumpeting the dominance of cloud computing are a bit ho-hum by now. Yet even by today’s hyped-up standards, a new survey by Gartner is astounding. In the research firm’s survey of 2,014 CIOs, 43% of respondents predicted that the majority of their IT infrastructure will run on cloud technologies within the next four years. In life sciences, the vast majority of data storage, data analytics and CRM implementations are cloud-based. Even so, the cloud has seen slightly slower uptake in clinical. Overwhelmed with market pressures, many clinical leaders have been distracted but are still curious about cloud and its bearing on clinical processes.  
 
However, there is still some confusion about the differences between true-blue cloud technology and traditional applications that are simply applications moved to an off-site computer warehouse and accessed over the web (aka hosted software). Cloud software, in contrast, is built on a multitenant architecture that supports many customers from a single, shared instance of the application. Each customer or “tenant” can custom-configure their own environment within the software, which is completely insulated from other tenants. Think of a neighborhood versus an apartment complex. In a neighborhood, each homeowner has his own yard to mow, plumbing to maintain and walkways to clear – but in an apartment complex, the lawn, plumbing, walkways, etc. are shared by all of the tenants. The customer configures their environment (‘apartment’) to meet their specific requirements and the vendor handles upgrades so all customers can take full advantage of the latest advancements, newest functionality and changes in regulations without ever having to reinstall. 
 
This is the magic of the cloud, though it’s not an illusionist’s sleight of hand. Here’s a look at five palpable ways the cloud can specifically impact clinical success.
 
Worldwide Access for Efficient Collaboration 
 
Clinical studies require intense collaboration among the sponsoring company, CROs, study sites, ethics committees and other stakeholders. Add to that the regulatory oversight and documentation requirements, and with all of these moving parts, collaboration has been a monumental challenge. 
 
In a 2012 NewVantage Partners survey of nearly 100 life science companies, 48% of sponsors reported that CROs are unable to work collaboratively while 57% of CROs echoed the sentiment about sponsors. But, the cloud enables sponsors and CROs to collaborate efficiently because it is securely and universally accessible without the challenges of distributing laptops, accessing a virtual private network, and trying to circumvent the organization’s information security policies or getting around a corporate firewall. Cloud-based eTMF (electronic trial master file) systems, for example, allow all approved collaborators to access clinical trial documents in real time with a single, secure log-in. This permits document exchange on demand, wherever authorized users can access the Internet. Sponsors, CROs and site personnel can quickly access a cloud-based eTMF from any device, anywhere in the world, then make necessary changes to documents and save them back to the central repository in the cloud for an up-to-date, single source of the truth.
 
A Bird’s Eye View Enables Superior Oversight 
 
Today’s CROs—who are under increasing pressure to reduce timelines, increase accuracy, and decrease overall costs—and sponsors—who are ultimately accountable to health authorities and patients—are both desperate for increased visibility into trial progress. However, incompatible systems and lack of accessibility has made it difficult for sponsors to see what is happening throughout the trial, including what documents are missing, what bottlenecks are causing delays, and more. 
 
The cloud, in contrast, provides sponsors with a bird’s eye view (pun intended) of the entire trial: from site initiation through publishing the trial dossier to health authorities. Cloud-based systems enable secure access 24x7x365 for ongoing visibility into submissions progress, for example, with a cloud-based submissions application.
 
Fast Implementation to Shed Time and Money  
 
According to recent studies, study start-up is one of the biggest time drains in a clinical trial. But, one big way to shave time is to implement a system designed specifically to support fast starts. A multitenant cloud system can be implemented in just four to six weeks and enable new studies to be easily incorporated, in contrast to traditional technologies that require six or more months of labor-intense programming with each new study. Plus, new users can be added in minutes without external IT involvement, making it fast and inexpensive to add new sites wherever they’re located around the world and incorporate all parties into the workflow. 
 
As important, with cloud-based solutions, there are no stopgaps in the process from lack of access points. Trial investigators and CROs can have documents uploaded directly into a cloud system over the web in real time rather than having to go back and forth manually with the sponsor via email (or even snail mail) to get all appropriate approvals. It’s the speed and availability of Amazon… but with the security mechanisms needed for clinical applications.
 
Inspection-Ready at All Times 
 
Preparing for an audit, today, often requires many weeks of scrambling to gather documents. The traditional method of tracking documents manually has led to inaccuracies, missing items and overall lack of control. Even after preparing, there may be issues uncovered during an audit that need to be corrected, causing delay. But, the cloud—ubiquitous worldwide—allows for just one, universally-accessible system so there’s no confusion about where a document resides. With proper reporting capabilities, a cloud application delivers real-time insights so sponsors can easily determine if documents are missing and always be ready for inspection.
 
Additionally, cloud-based systems provide secure, online access to health authorities, supporting the growing movement toward remote audits. All they need is a login and a specific role that delineates what they see, no company laptop or VPN needed. “Audit prep can go from many weeks to just a couple of hours with a cloud-based system,” said Linda Danielson, CEO of IDDI, a specialty CRO. 
 
Flexibility to Grow and Change as Needed 
 
Because cloud system infrastructure is managed by a third-party and shared by all, cloud applications allow clinical teams to increase capacity or add capabilities on the fly without investing in new hardware, hiring new personnel, or licensing new software. When the cloud provider updates its software with new features or performance enhancements, the application is pushed out through the cloud to all customers—transparent to end users. These upgrades can simply be turned on by users as needed with just a touch of a key, and system changes can be made in minutes (not months). That means every time the DIA TMF Reference Model is appended or there’s a change in process… a cloud-based solution keeps pace. 
 
Jennifer Goldsmith is vice president of Veeva Vault for Veeva Systems. She can be reached at jen.goldsmith@veeva.com. 
 
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