Unlocking Productivity in Life Sciences with Consolidated
by Joe Golemba, Vice President, Product Management, Oracle
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.
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.
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
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
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
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.
require the ability to index multiple data repositories, enabling a single
search to reference multiple data sources and provide an integrated results
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
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
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.