SaaS in the Regulatory Content Space: It’s the New Black!

Gone are the days of highly customized, heavy footprint technologies with complex, over-engineered work streams. The Regulatory industry is looking for a kinder, gentler solution that doesn’t require teams of support personnel to install and validate a software update. They are looking for a simple approach that supports daily operations, without requiring budget-busting licensing fees. And they have found it in SaaS (Software as a Service).

Software as a service, also known as SaaS, is not a new concept but it has made a relatively recent appearance in the Regulatory technology world. Being the conservative buyers that we are, regulatory teams don’t move quickly toward cutting edge technologies. And when it comes to outsourcing anything, we are, at best, middle adopters. The perceived risk of such innovative approaches and the inevitable need (cost) for validation of an environment make us think twice about the technologies we implement and the functionality we need to minimize risk and operate effectively.

But a new day is dawning. The proliferation of web-based systems and tools, built on multi-tenant architectures, has enabled tool vendors to offer new delivery models that are far more palatable from a budget and a support perspective. The technology landscape is changing and so are the market dynamics.

Most large pharma companies are shedding their heavy IT infrastructures and looking for more cost effective solutions that enable them to store, manage and access content and metadata across the drug development lifecycle. At the same time, small companies need the same functionality to support a smaller user base. They don’t have the infrastructure support or the deep pockets for a big implementation project. They need certain core functionality today to support content driven processes. They don’t have the time, resources or inclination to participate in the development of a highly customized solution.

That’s where Content Management in a SaaS model comes into the picture. In a SaaS subscription model, companies usually pay a project set-up fee and then monthly user access fees for a content management environment. Since the environment is hosted, there are no hardware acquisition costs. This model minimizes the initial cash outlay whilst also giving companies a predictable budget based on an expected number of users and the functionality they require.

In a SaaS environment, access to the technology is delivered as a ‘service’. This service usually includes things like a documented and tested disaster recovery plan, management and maintenance of the hosted environment and roll out of software updates. This is where companies can begin to recognize the true recurring savings. Implementation tasks are simplified and presented with the goal of shortening the time-to-productivity for users. Preconfigured file folder structures, proven workflows and templated content give new users the tools they need to do their jobs quickly and efficiently. In a SaaS content management environment, the regulatory team no longer has to go through lengthy validation activities before they can get any value out of the system. The technology vendor takes responsibility for validation of the environment, documents their approach and makes the documentation available for audit by customers. The customer can then reference the documentation in their own validation plan or execute additional test scripts, depending on their organization’s validation strategy.

One of the very interesting corresponding trends that is related to SaaS technologies is the concept of outsourcing the technology and the process. Many companies are looking to outsource certain activities or tasks within the regulatory lifecycle and they are choosing to outsource the technology along with these tasks. SaaS content management technologies are enabling stakeholders (licensing, development and outsourcing partners) around the globe to access certain information in the content repository to support global regulatory filings. Team members may be located in another department, at another site, on the other side of the world or in partnering organization. This secure yet collaborative environment supports the global nature of regulatory as well as the need for one source of information that can be accessed by “team members” who may reside outside of the company’s firewall.

Excitement about the SaaS model has been growing for some time now. Some market analysts suggest that the majority of enterprise systems in the next 10 years will be accessed via a SaaS model. The heightening interest lies in the potential to minimize system ownership costs while streamlining the start-up. Companies have made the strategic decision to outsource everything from infrastructure to sales and marketing. They don’t want to spend scarce dollars on maintaining a complex environment. Too many companies are still in the process of maintaining or retiring highly customized document management systems. These systems pre-date the availability of SaaS offerings. You can hear some great war stories from those who were involved in the “never-ending” global implementation projects for regulatory document management. But those stories are artifacts of a different time and place. Today, companies value efficiency, nimbleness and cost effectiveness over the notions of “ownership and control”. They are pushing responsibility for and access to regulatory content outside of the traditional organizational boundaries. Content management in a SaaS model supports this trend. It is changing the way we operate and raising the bar when it comes to finding new ways to manage global content in a quicker, cheaper and more efficient manner.