Oct 17, 2005 | The infamous pharma silo may well be on the way out when it comes to content management. The catalyst is an increasingly competitive, more closely regulated environment that is forcing companies to harmonize their business processes.
Enterprise content management (ECM) makes good business sense. Heightened consolidation through international mergers and acquisitions and collaborative partnerships is compounding the data overload generated by global clinical trials. Furthermore, lean pipelines and a slew of imminent patent expirations have generated a need for creative solutions, such as expanded indications and improved branding. The upshot is R&D must collaborate more closely with marketing, and vice versa.
On the regulatory front, international agencies have been investigating ways to rationalize and harmonize regulations for drug approval. But far from simplifying the situation, compliance requirements are becoming more complex, bridging every aspect of a company’s business and denoting a need for enhanced information sharing. Technology, however, is up. Today, breakthrough technologies that consolidate around a core set of standards are replacing clunky legacy systems.
Pharma and biotech companies are latching onto the opportunity to institute process harmonization and standardization across the enterprise. The question is not why or even when, but at what pace. But because of widely varying needs, companies are phasing in ECM in different ways. Four common models for ECM implementation are emerging. These are not mutually exclusive, and in fact, many companies are pursuing multiple models.
The Top-Down Model
This model employs a structured rollout that establishes a foundation for eventual enterprisewide adoption of a standardized ECM system. Standards are set for harmonized system design and business processes with the aim of simplifying document management and reducing costs. Such a model defines and clarifies shared functional capabilities to ensure consistency in how documents and content are gathered, stored, and retrieved. Decision making stems from senior management to avoid situations where decisions are revisited and revised.
Since silos cannot be deconstructed in a day, ECM is rolled out function by function on a preset schedule. And while it is agreed that harmonization is the ideal, the company recognizes that some differences may be necessary when used for some applications, for example, when documents that were created for internal purposes cross over into the regulated space. In such cases, the original foundation can be tailored to each vertical application’s requirements while still maintaining the companywide standards and practices.
The Business-Driven Model (Bottom-Up)
In this model the departments with the most pressing business needs dictate the terms of ECM adoption. It is these individual functions, or divisions, that make the buying decisions on how to tackle process and systems challenges.
As the ECM solution becomes entrenched within a function, attention turns to the next step in a multiphase adaptation. This systematic approach helps minimize the cost of implementation, but lacking a centralized approach, there is a danger of inconsistency as each function adapts the solution according to preexisting operating practices.
Center of Knowledge Model
By establishing an ECM center of excellence where the IT knowledge base resides, a company places document management at the heart of its operations. Through this model, the company’s enterprise IT team takes charge of its myriad functions by becoming ECM experts.
Instead of divisions driving the decisions, the enterprise invests in one common enterprise architecture and implements the system incrementally across business functions on an as-needed basis. The model contains three core configurations: a configuration that acts as a collaboration tool that allows the free flow of information between users and is uninhibited by security and encryption; a configuration with a higher level of oversight that maintains a level of flexibility; and a process-centric configuration whereby access to documents is tightly controlled.
Rapid Deployment Model
This approach ensures its information assets are centrally managed while allowing the solution to be implemented function by function. It eradicates the cumbersome use of multiple document repositories, hence improving efficiency, and cuts the costs involved in creating and managing content. For example, costs associated with the development and support of content can be halved worldwide. While the model brings standardization to content management, it provides the flexibility to make changes as needed. Most significantly, the model provides the company with the resources and wherewithal to manage its intellectual capital.
The pace of change is dictated by a company’s particular challenges — be they overcoming the burdens of legacy systems, working through hierarchical issues, or pure cash-flow problems. The most basic elements each model must contain for continued success are a vision for what the solution should achieve and true executive buy-in. Armed with executive-level support and a clear plan of action, life sciences companies are well positioned to beat the silo.
Jeffrey Klein is vice president, product strategy, for First Consulting Group Life Sciences. E-mail: firstname.lastname@example.org.