By Michael Snow on Jun 07, 2012
Unlocking Productivity in Life Sciences with Consolidated Content Management
by Joe Golemba, Vice President, Product Management, Oracle WebCenter
As life sciences organizations look to become more operationally efficient, the ability to effectively leverage information is a competitive advantage. Whether data mining at the drug discovery phase or prepping the sales team before a product launch, content management can play a key role in developing, organizing, and disseminating vital information.
The goal of content management is relatively straightforward: put the information that people need where they can find it. A number of issues can complicate this; information sits in many different systems, each of those systems has its own security, and the information in those systems exists in many different formats.
Identifying and extracting pertinent information from mountains of farflung data is no simple job, but the alternative—wasted effort or even regulatory compliance issues—is worse. An integrated information architecture can enable health sciences organizations to make better decisions, accelerate clinical operations, and be more competitive.
Unstructured data matters Often when we think of drug development data, we think of structured data that fits neatly into one or more research databases. But structured data is often directly supported by unstructured data such as experimental protocols, reaction conditions, lot numbers, run times, analyses, and research notes. As life sciences companies seek integrated views of data, they are typically finding diverse islands of data that seemingly have no relationship to other data in the organization. Information like sales reports or call center reports can be locked into siloed systems, and unavailable to the discovery process. Additionally, in the increasingly networked clinical environment, Web pages, instant messages, videos, scientific imaging, sales and marketing data, collaborative workspaces, and predictive modeling data are likely to be present within an organization, and each source potentially possesses information that can help to better inform specific efforts.
Historically, content management solutions that had 21CFR Part 11 capabilities—electronic records and signatures—were focused mainly on content-enabling manufacturing-related processes. Today, life sciences companies have many standalone repositories, requiring different skills, service level agreements, and vendor support costs to manage them. With the amount of content doubling every three to six months, companies have recognized the need to manage unstructured content from the beginning, in order to increase employee productivity and operational efficiency.
Using scalable and secure enterprise content management (ECM) solutions, organizations can better manage their unstructured content. These solutions can also be integrated with enterprise resource planning (ERP) systems or research systems, making content available immediately, in the context of the application and within the flow of the employee’s typical business activity. Administrative safeguards—such as content de-duplication—can also be applied within ECM systems, so documents are never recreated, eliminating redundant efforts, ensuring one source of truth, and maintaining content standards in the organization.
it in context
Consolidating structured and unstructured information in a single system can greatly simplify access to relevant information when it is needed through contextual search. Using contextual filters, results can include therapeutic area, position in the value chain, semantic commonalities, technology-specific factors, specific researchers involved, or potential business impact.
The use of taxonomies is essential to organizing information and enabling contextual searches. Taxonomy solutions are composed of a hierarchical tree that defines the relationship between different life science terms. When overlaid with additional indexing related to research and/or business processes, it becomes possible to effectively narrow down the amount of data that is returned during searches, as well as prioritize results based on specific criteria and/or prior search history. Thus, search results are more accurate and relevant to an employee’s day-to-day work.
For example, a search for the word "tissue" by a lab researcher would return significantly different results than a search for the same word performed by someone in procurement.
Of course, diverse data repositories, combined with the immense amounts of data present in an organization, necessitate that the data elements be regularly indexed and cached beforehand to enable reasonable search response times. In its simplest form, indexing of a single, consolidated data warehouse can be expected to be a relatively straightforward effort.
However, organizations require the ability to index multiple data repositories, enabling a single search to reference multiple data sources and provide an integrated results listing.
Beyond yielding efficiencies and supporting new insight, an enterprise search environment can support important security considerations as well as compliance initiatives. For example, the systems enable organizations to retain the relevance and the security of the indexed systems, so users can only see the results to which they are granted access. This is especially important as life sciences companies are working in an increasingly networked environment and need to provide secure, role-based access to information across multiple partners.
Although not officially required by the 21 CFR Part 11 regulation, the U.S. Food and Drug Administraiton has begun to extend the type of content considered when performing relevant audits and discoveries. Having an ECM infrastructure that provides centralized management of all content enterprise-wide—with the ability to consistently apply records and retention policies along with the appropriate controls, validations, audit trails, and electronic signatures—is becoming increasingly critical for life sciences companies.
Creating an enterprise-wide ECM environment requires moving large amounts of content into a single enterprise repository, a daunting and risk-laden initiative. The first key is to focus on data taxonomy, allowing content to be mapped across systems. The second is to take advantage new tools which can dramatically speed and reduce the cost of the data migration process through automation. Additional content need not be frozen while it is migrated, enabling productivity throughout the process.
The ability to effectively leverage information into success has been gaining importance in the life sciences industry for years. The rapid adoption of enterprise content management, both in operational processes as well as in scientific management, are clear indicators that the companies are looking to use all available data to be better informed, improve decision making, minimize risk, and increase time to market, to maintain profitability and be more competitive.
As more and more varieties and sources of information are brought under the strategic management umbrella, the ability to divine knowledge from the vast pool of information is increasingly difficult. Simple search engines and basic content management are increasingly unable to effectively extract the right information from the mountains of data available.
By bringing these tools into context and integrating them with business processes and applications, we can effectively focus on the right decisions that make our organizations more profitable.
Oracle will be exhibiting at DIA 2012 in Philadelphia on June 25-27. Stop by our booth (#2825) to learn more about the advantages of a centralized ECM strategy and see the Oracle WebCenter Content solution, our 21 CFR Part 11 compliant content management platform.