Did Veeva Vault Just Make Regulated Content Management Systems Sexy?

7 minute read
Virginia Backaitis avatar

Content Management Systems at Life Sciences companies typically don't have many fans and are rarely seen as beautiful. Veeva Systems is out to change that.

Regulatory users find traditional CMSs to be slow, difficult to useandburdensome, System Admins need to be on alert 24/7 regardless ofhowwell they do their jobs, and IT Directors don't win much praise for deploying upgrades or new releases because there's never enough bangforthe time/manpower that they require and the dollars spent.

The bottom line is that most Regulatory CMSs inthe Life Sciences Industry are seen as an ugly, but necessary, evilbecause without them companies can't bring new drugs to market, complywith FDA and ICH regulations, or minimize their chances of going tojail for non-compliance.

That being said, why would a hot, happening software company, like five-year old Veeva Systems, and a group of seasoned Regulatory Life Sciences and Web CMS/CRM experts want to enter that business? Because they were convinced that recent technological advances (SaaS and the Cloud) and their knowledge of the evolving pharmaceutical/biotech industry would enable them to build a solution that would do something rather astounding -- delight users and deliver competitive advantages to their customers.

Reflecting Changing Needs

Not only that, but they also felt that the time was right, the market was crying out for disruption. "Customers were looking for something different," says Jennifer Goldsmith, who was recently selected by PharmaVOICE as one of the top 100 most inspirational and influential people in the life sciences industry.

Goldsmith, together with Eric Bezar, a former Vice President of Product Management at Salesforce.com, and a team of recruited industry A-players built that "something different" at Veeva Systems and named it Veeva Vault. Vault is the first regulated Web CMS built specifically for the Life Sciences industry. Veeva Systems is a CRM which the IDC just named as one of the top 10 Life Sciences software providers.

"The major Content Management systems used by Life Sciences and Biotech companies were built 15 years ago,” says Goldsmith. That was before the cloud, before the consumer web paradigm, before globalization, and when collaboration meant walking down the hall to discuss a document.

"A lot has changed since then," (but the Content Management Solutions being used), says Goldsmith. She explains, for example, that today’s Life Sciences companies trust their partners in ways that they didn’t a decade ago. "Collaboration" circa 2012 means sharing information not only within the firewall but also with an ecosystem that often includes: CROs (Contract/Clinical Research Organizations), co-marketing and co-development partners, contract sales providers, creative agencies and so on ...

Yesteryear's CMSs weren’t designed to do that; bringing an outside entity to work with your CMS is often a major undertaking. Goldsmith claims that theWeb CMSs most Life Science companies use are so far from plug’n’play and intuitive that companies have to spend hours and/or days just setting partners in order for collaboration to even begin. With Veeva Vault's SaaS framework, partner firms can be brought in via a few simple clicks and users can be proficient and productive in less than half of an hour.

Ease of Use Plus Functionality

Why the disparity? Because Vault was built to mimic the consumer experience. Vault is browser based, searches surface results as you type, much like Google or Facebook. When you don't know exactly what you're looking for, Vault offers detailed search filters, just like LinkedIn and Zappos. Users don’t have to think about folders like they do with other CMSs. Goldsmith says that both her 9-year-old child and her 80-year-old mother learned how to work with Vault in a matter of minutes.

And Vault's ease of use doesn't come at the expense of any Regulatory CMS functionalities. At present Vault includes:

Vault PromoMats which track the entire lifecycle of a document -- from concept and strategy, to submission and Medical, Legal and Regulatory (MLR) review and to the distribution and withdraw -- in one, simple-to-use system.

Vault Quality with which users will always have access to the right SOPs, manufacturing and validation documentation at the right time, through features like type-ahead search and mobile device document viewing.

Vault AdminDocs which simplify processing of controlled administrative documents such as contracts and Human Resources forms by allowing you to create, review, revise and approve documents online.

Vault R&D which makes it easy to collaborate with CROs, co-development partners and others as easily as you do with colleagues down the hall. It allows you to manage research and development documents from concept to submission and beyond.

Vault eTMF (electronic Trial Master File) which eliminates snail mail (and massive shipping costs) by allowing life sciences organizations, CROs and investigators to upload and manage trial documents in a secure and easy-to-use repository.

Learning Opportunities

Vault MedInfo which eliminates the need to sift through shared drives or intranet sites. Vault MedInfo lets you know which documents are available for distribution the minute they are approved. Plus, Vault's simple-to-use search and tracking means you always know where your documents are and how they have been used.


The Veeva Vault Library View

Regulatory Cloud

It's interesting to note that Vault sits on Veeva’s Regulatory Cloud vs. on premises or on the Private Cloud that most Life Sciences technology vendors talk about. What's the difference between a Private and a Regulatory Cloud? "A private cloud is like a public cloud just sitting in a different zip code," says Goldsmith. "Our Regulatory Cloud is where all Veeva customers sit, we know exactly where the servers are and they are SAS Type II compliant."

It’s also worth mentioning that Vault is a true SaaS solution which is very different from the cloud-based or hosted solutions that other Web CMS vendors have recently begun to talk about. Goldsmith says that it's important to distinguish between Infrastructure as a Service (IaaS), Platform as a Service (PaaS) and Software as a Service (SaaS).

According to Wikipedia, Infrastructure as a Service is the most basic cloud computing model. Infrastructure refers to virtual machines, servers, storage, load balancers and the network. The IaaS model holds that businesses rent space on the cloud (which is typically provided by one or more vendors) and that they themselves are responsible for installing and supporting operating system images on the machines as well as their application software.

Platform as a Service is a model in which companies not only rent space on the servers as in IaaS but they also rent the system software to use in them.

Software as a Service is a model in which companies rent space on servers, rent the system software that runs in them, as well as databases and applications.

Veeva Vault says that it is the first vendor to offer a Regulated Content Management SaaS solution built exclusively for Life Sciences.

So what does the market think of Vault thus far? Most of the typically tight-lipped Life Sciences companies that I’ve spoken to give it a thumbs up. “It’s really beautiful,” says a project manager whose employer won’t allow her name to be used.

The only hesitation we’ve heard thus far is about the SaaS model and moving to the cloud as a whole; many companies are still hesitant to go there. But as the Cloud goes mainstream (and it already is) that’s a problem that will likely solve itself.

What’s most remarkable is the speed at which Vault has won over new clients in a market which is reluctant to make changes. In the six months since it has become available to the general public it has brought on 16 new clients.