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Veeva Brings Clinical Trial Collaboration to the Cloud



By Ann Neuer 
 
November 4, 2013 | If the strong showing of Veeva Systems’ October initial public offering (IPO) is any indication, the biopharmaceutical industry is poised to move more processes to the cloud.  As evidence, Veeva, a provider of cloud-based tools, was launched in 2007 focused exclusively on life sciences, and has seen rapid adoption of its solutions leading to healthy growth in net income, and a market capitalization exceeding $4 billion. 
 
GoldsmithJennifer Goldsmith, Vice President, Veeva Vault, the company’s suite of content management solutions, explains, “There is growing comfort with cloud applications because we are seeing implementations going very well.  People are seeing the benefits in multiple areas of the life sciences ecosystem.  Clinical data from EDC systems, and information from clinical trial management systems as well as customer relationship management (CRM) and promotional materials management are moving to a regulated cloud environment.”
 
To manage the vast amount of documentation associated with clinical trials, Veeva offers Vault eTMF (electronic trial master file), a Software-as-a-Service (SaaS) cloud-based technology that enables real-time access to clinical documentation at every point in a trial's set-up and execution.  This functionality is essential to sponsors, contract research organizations (CROs), sites, institutional review boards, and other parties looking to collaborate seamlessly as a trial unfolds.  “The processes of collecting and organizing clinical documentation such as curriculum vitae (CVs), ethics committee approvals, case report forms, and informed consents are often still manual and paper-based.  Vault eTMF provides a single, secure place for all clinical players to share their documentation in a standardized and fully reportable system,” says Goldsmith. 
 
Collaborating in the cloud is gaining traction in the clinical trials sector and is a step beyond traditional methods such as collecting and shipping documents across the globe, and sending unsecured e-mails with attachments.  Vault eTMF’s SaaS-based platform takes the process one step further by eliminating the need for onsite hardware-based systems that require intricate firewalls, specialized backup procedures, and ongoing oversight and updating.  Instead, Vault eTMF provides an application where everyone can participate without the need for special resources such as a secure virtual private network (VPN), for example.  And documents are rendered in submissions-ready format so that they can readily be used downstream in regulatory submissions. 
 
In terms of where the life sciences sector is when it comes to clinical trial documentation, Goldsmith says companies fall into one of three buckets: entirely paper-based, which she says is shrinking; a hybrid approach whereby the paper-process is generally followed and is then scanned to create an electronic TMF with some simple searching functions; and third is a true eTMF.  This refers to creating files electronically and taking them through the electronic process to derive a lot more content.  “This is when the eTMF becomes a strategic asset as you can gain insight from the data and metadata that can be used to improve future trial design,” Goldsmith points out.   
 
Specifically, a truly electronic TMF allows sponsors and CROs to look at process metrics to determine where changes are needed to facilitate faster study start-up or better study execution.  A collaborative eTMF provides real–time visibility into the status of the TMF, such as missing documents from sites, and prompts action by sites to correct those deficiencies.  By completing documents accurately and on time, the site’s level of inspection readiness increases.  According to Goldsmith, “What happens a lot today is that things are processed at the end of the study.  That’s when sponsors discover that documentation may not be entirely complete, so they have to spend time finishing up after the fact.  There’s a real cost to operating this way.”  
 
1113_MorrisonRick Morrison, CEO and Founder of Comprehend Systems, a provider of SaaS tools to accelerate clinical trials, says Veeva’s IPO is a huge win for enterprise SaaS and life sciences.  He believes Veeva is a good example of a company that is showing the value of the cloud and how it is being adopted in the life sciences industry.  He explains, “The industry is very much changing.  The way enterprise software companies worked CRM before involved multi-million dollar contracts for user licenses.  It was a major capital expense, and companies had trouble implementing the technology, a process that could easily cost millions of dollars more.”  
 
Morrison adds that with the cloud, CRM users pay only for what they use, instead of having a situation in which more than half of the licenses go unused.  “There is a wall of data coming toward us so moving more functions to a regulated cloud environment makes good business sense.”  
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