GUEST COMMENTARY | David Hardison 

April 16, 2004 | Innovations are allowing companies to re-address how they manage content and data across the enterprise. Recent advances in content management, collaboration, and portal technologies have enabled a new paradigm that considers the "extended enterprise."

This new model considers process inter-relationships regardless of function, geography, or organization, coupled with the marriage of regulated information and team-based collaboration. The extended enterprise forces organizations to view document management from a business process standpoint that results in streamlined information access and reduced costs.

Companies can lower costs by standardizing technology tools, content templates, life-cycle structures, server/storage infrastructure, and taxonomies, to name a few. Adopting a single, configurable solution to control an industry-standard content management platform for clinical trials, research and development submissions, Good Manufacturing Practice (GMP) requirements, marketing, and medical information could produce annual savings of $5 million to $10 million.

A single solution to manage content for clinical trials, manufacturing, marketing, and medical information could produce annual savings of $5 million to $10 million.

Further benefits of this model will accrue in cases where sharing knowledge across the enterprise is instrumental in the development, marketing, and sale of new drugs. Electronic lab notebooks allow knowledge to be immediately captured, stored securely, and shared. This can reduce redundancies, improve innovation, speed time to patenting, and, most importantly, help capture and preserve the company's intellectual property.

Achieving tangible benefits in enterprise content management (ECM) requires a "plan strategically, execute tactically" framework. Some companies have graduated from a functional paradigm to an enterprise view that includes all business units. Although an important advance, this view leaves out many critical elements, including vendors, partners, and customers. It is also important not to neglect interdepartmental relationships, as cost savings in one area could hike expenses elsewhere.

An ECM program that unites and leverages more key business elements while running on a common infrastructure will reduce total cost of ownership. Additionally, accessing that content through emerging technologies such as portals and collaboration tools can replace costly desktop clients and make the knowledge worker more productive.


Step One: Strategic Planning 
Before leaping to implementation, an organization should first assess the current state of its policies, business processes, external partners, customer information needs, and its information systems. Finding out what is possible with new technologies helps shape goals. The intent is to create a realistic future state based on policy, business process, and organizational perspective.

The future state must align with the overall business goals to prioritize initiatives based on company resources and cultural ability to change. Some organizations fail in their content management programs because they view the project solely from a technology perspective, not as a business function supported by technology.

Once it has conceived the strategic future state, a company needs to build a tactical transformation plan to draw out the various policy, process, and technology initiatives required. This necessitates a business plan that incorporates expected financial benefits, as well as a plan for governance and risk management.


Step 2: Cost Modeling 
A business case that boasts cost savings will be attractive; however, one that displays top-line growth coupled with cost savings will be the winner. But calculating an accurate return on investment can be tricky. The first question is, "How does executive management view value?"

The answer is critical to how the financial model is built from a discretionary/ nondiscretionary expense standpoint. Additionally, it is important to look at which factors constitute an opportune investment. This is important in determining how the initial "infrastructure investment" must be made. Having a valid cost baseline will play a big role. Any ROI calculation is a moving target, and calculating a number that has predictive value will require many iterations and reviews. For example, one company's approach to managing Trial Master Files varied significantly by location. (Trial Master Files are the essential documents that the sponsor maintains to demonstrate compliance with Good Clinical Practice by each and every investigative site participating in a clinical trial.) By adopting standard processes, automating them, and eliminating paper, a 50 percent ROI was predicted to be achieved after the first year.

There are hundreds of data points to include when developing models of revenue generation and cost savings. In the area of so-called hard benefits, there are advantages such as revenue growth from decreased time to market. Soft, or indirect, benefits include an increase in customer satisfaction or brand enhancement.

An extended ECM program can clearly deliver success. Leveraging common infrastructure, templates, and collaboration standards across internal and external entities through this new approach offers the greatest value proposition in content management. Though it requires the creation of a skilled, cross-functional team, and meticulous strategic planning, it is an innovation that every bioscience corporation should explore.

David Hardison is vice president, life sciences, at First Consulting Group. E-mail: dhardison@fcg.com.