- CodeScience took VRS from “back of the napkin” to functional Beta in just 18 weeks, 75% faster than VRS estimates an in-house team could
- CodeScience delivered first Salesforce-based AppExchange product for biopharma document management
- Salesforce cloud capabilities allow VRS to beat their legacy competitors on price by an average of 65%, with superior product capabilities and UI
- CodeScience accelerated AppExchange availability of VRS product by 35%
Biopharma companies are required to flawlessly submit documentation to the FDA under heavily scrutinized regulations. During early drug trials, the price of any misstep due to documentation carries a price tag that can reach into the millions of dollars. While there are legacy applications that try to help early-stage biopharma teams advance their drug approvals, none have used a true cloud-based system to do so—until Virtual Regulatory Systems (VRS).
“Navigating FDA document submission is never going to be a core-competency of biopharma professionals—particularly not our core market, which is usually two scientists and a molecule,” said Ken VanLuvanee, President/CEO of VRS. “We’re focused on helping our customers deliver life changing drugs, and while FDA documentation is essential to consumer safety, it’s simply not a natural process for scientists to navigate.”
VRS was founded by industry experts to leapfrog notoriously expensive and difficult to manage legacy DMS’ (Document Management Systems) with a lower-cost solution built on a secure cloud-based infrastructure. This new DMS allows emerging biopharma companies to slash documentation overhead and streamline FDA submissions to eliminate many stumbling blocks that trip up small teams.
“Ken and I have worked together for over 15 years, so we know regulatory DMS inside and out when it comes to the FDA,” added Bruce Salkovitz, Director of Product Strategy at VRS. “We assessed both Salesforce and Microsoft, but quickly realized Microsoft’s Sharepoint would expose our customers to a single point of failure as well as complicated, expensive application and SQL licenses. Because we wanted our customers in the cloud, selecting Salesforce was easy, because to us they are the first company to truly deliver a cloud-based application layer.”
“Bruce and I knew from the outset that we didn’t want to build this application ourselves,” followed VanLuvanee. “We wanted a partner that could actually be our development team as a true extension of our company; after an initial 15 minute conversation with CodeScience, we knew the intellectual DNA of our organizations was a perfect match.”
As a two-man team, Ken and Bruce bring a combined 40+ years of experience in regulatory DMS and publishing for biopharma, so they knew the disruptive functionality they wanted their app to have. However, because VRS has no product development staff, they needed a total solution with technology from Salesforce and product development from CodeScience.
“At CodeScience, we know we’re not FDA experts, and our friends at VRS know they’re not Salesforce experts, so we bonded by sharing our expertise to build an innovative product in an incredibly high-stakes industry,” said Jake Wills, Product Manager at CodeScience. “Our ongoing relationship with VRS illustrates what the CodeScience PDO practice delivers. We can be your CIO, development, product, and testing team all at the same time…ultimately, our role is translating your expertise into a Salesforce app that delights your customers.”
The product, named rsDM, simplifies the notoriously complicated FDA document submission process. A key challenge for the project was to build a UI that would look and feel like a desktop application since that’s what VRS customers would be most familiar with. Collaborating as a single team, VRS and CodeScience worked through three primary iterations of the UI.”
The rsDM UI is remarkable because it allows users to create document repositories, then edit metadata, add versions, and manage approvals. It also allows document creators to define the document approval process, which becomes a legal record at the completion of reviews. These are significant advances against existing products, which allows VRS customers to streamline FDA submissions spend less time pushing paperwork, and more time modifying molecules.
“I’ve been writing code for almost 25 years, and working with CodeScience is my first ‘hand in glove’ experience with an outside development partner. They are relentless in understanding our needs and uncompromising in their delivery,” said Salkovitz. “Joining the AppExchange also underscored Salesforce’s global brand recognition and value. We initially launched our product with a U.S. focus, but our first two customers were from Australia and England.”
“My surprise CodeScience benefit is how connected they are within Salesforce’s executive management,” followed VanLuvanee. “Early in development, CodeScience introduced us to leaders from the Salesforce ISV and healthcare teams that helped us get the most out of our investment in their platform—this would have never happened without them.”
Napkin to Awesome
Initial focus was on the data model to support hierarchical relationships, custom user permissions, and integration with off-platform secure file storage. During this phase, native Salesforce page layouts were used for the proof of concept, which allowed for rapid iterations without the complication of UI impact.
Simple, interactive HTML prototypes were used to test different concepts, both internally and with test users. Rudimentary prototypes allowed rapid revisions and kept testers as focused on specific UI elements. Since the target users for rdDM are most comfortable with traditional desktop graphical file browsers, VRS chose a simple Cabinet/Folder/Document/Version hierarchy that expands to the right as users click through the structure.
After the basic interactions were designed, the custom UI was developed with an eye towards Adaptive Design so that it would work well on different device types—including Salesforce1. In all UI elements, simplicity was the guiding principle, resulting in a clean and efficient user experience without the distractions of unneeded features or design distractions.
“For our initial sprint, CodeScience took us from ‘back of the napkin’ to a functional Beta product in just 18 weeks. It would have taken a year if we attempted to build this on our own, so CodeScience saved us at least 8 months of development time to deliver a functional beta,” said Salkovitz. “Our accelerated time to market gave us a powerful advantage with a disruptive product; now we’re iterating like crazy to incorporate customer feedback and expand our market share.”
“In a legacy-oriented industry, CodeScience built us an app that incorporates the latest cloud-based technology and does things none of our competitors come close to,” added VanLuvanee. “CodeScience continually pushed us to understand the root of what we wanted, and because of that, they accelerated the time to market of our final product by at least 35%.”
As the only application of its kind on the AppExchange, VRS offers free 30-day trials to potential customers so they can see the difference for themselves. For biopharma companies that have historically been slowed by overly complex applications, the simplicity of rsDM helps them optimize workflow and eliminate headaches such as licensing, hosting, networking, disaster preparedness, and high set-up fees.
“We know from experience that most biopharma companies are stuck in the old way of doing things,” added Salkovitz. “In biopharma, where innovation is key, that’s crazy. Because we built on the Salesforce Platform with the help of CodeScience, we’re now beating our legacy competitors by 65% on price and with better functionality than they can hope to offer for a very long time.”
VanLuvanee concluded, “CodeScience has bent over backward for us; they helped us solve a highly complicated business problem with technology, but at the same time, they knew we didn’t want to become Salesforce experts. Our rsDM product from CodeScience allows us to help our customers innovate faster and hopefully to improve lives more quickly…which is exactly why we started Virtual Regulatory Systems.”
- Secure – HTTPS security to ensure encryption across all communication connections.
- Easy to use – You can use rsDM without extensive training or implementation projects because it’s so intuitive.
- Compliant – Supports 21 CFR Part 11 compliant management of documents and records.
- Inexpensive – rsDM delivers low cost electronic compliance, with no long term licensing commitments.
- Completely online – 100% SaaS, rsDM’s full capabilities can be reached securely from anywhere with a network connection.
- Standard – rsDM is based on an emerging industry best practice for organization of documents—the DIA Electronic Document Management (EDM) Reference Model
- Submission focused – Use the Submission Assembly Manager (SAM) to organize your documents into submissions to enable the Regulatory Operations process.
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