Life sciences companies can avoid unnecessary risks and common sources of cost escalation by optimizing and centralizing the management of their promotional material references.
1. Promotional References: Assessing
Relevance, Ensuring Compliance,
Avoiding Unnecessary Spend
Life sciences companies can avoid non-compliance risks and
common sources of cost escalation by optimizing and centralizing
the management of their promotional material references.
Executive Summary
When organizations properly design, govern
and implement a global medical-regulatory
reference library and support service, they
can be assured that critical claims documents
(e.g., package inserts, message maps, reference
articles, etc.) are accurate, auditable and
compliant with both internal and external legal-
regulatory governing bodies.
Across the life sciences industry, however, there
is a lack of formalized governance and dedicated
support services, which has led to unfettered user
access, inconsistent product naming, erroneous
nomenclature for reference metadata, significant
reference errors/duplications and overall global
stakeholder confusion.
By our estimates, each individual life sciences
organization is overspending by millions of
dollars on the management and purchase of
references, and more importantly, they are
placing themselves at very high risk for non-
compliance on audit findings.
As business leaders increase pressure to identify
opportunities for significant process optimi-
zation — and regulatory bodies intensify their
scrutiny to substantiate supportive claims — life
sciences companies are beginning to seek a single
strategic partner that can provide them with
proven guidance for a centralized, cost-effective
approach to process, technology and change
management.
This white paper describes our methodology to
help life sciences companies assess the state of
their existing reference libraries. It also offers
recommendations to help these organizations
make the transformation to an effective, efficient
and compliant global reference library structure
and service.
cognizant 20-20 insights | september 2016
• Cognizant 20-20 Insights
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Reference Library Assessment:
Getting Started
A reference library assessment typically uncovers
root causes, major flaws and insights into
improvements, including:
• Products mapped to one or more countries,
creating a new country group (e.g., Product A
is mapped with multiple European countries,
such as Spain, the UK and Germany).
• Ambiguous or truncated product names
(e.g., Derm, Derma and Dermatology).
• Duplicate reference articles/journals.
• Assurance that purchased assets have the
value invested.
• Added costs and resource efforts due to
duplicate information to justify a business case.
• The ideal structure moving forward to ensure
compliance and minimize costs.
To address these concerns and goals, each orga-
nization must assess people, process, technology,
policies, standard operating procedures, work
instructions and existing external contracts, as
well as the gaps in roles and responsibilities. While
the final refined state of the reference library
process will vary for each company, key recom-
mendations for improving ongoing reference
library operations include the following:
• Centralize the reference library input
process. The reference input process should
be centralized and user access restricted to a
few dedicated users. For example, in a region,
only one or two individuals should be allowed
to purchase/manage the references, and enter
or remove data in the system. Other users
should have only limited access to the system.
• Dedicate a reference librarian assigned
to the task. A user with complete access to
the system should be able to enter or update
references and purchase references on others’
behalf or should be assigned as a reference
librarian. Every query to the system should
pass through this person to avoid unnecessary
or faulty system usage.
• Implement a gating filter in the reference
upload process. Even in the presence of
a reference librarian, proper gating filters
should be implemented to restrict users from
selecting the wrong information or following
an incorrect path. This includes a gate for
selecting the correct product, country and
permission selection groups at the configura-
tion level.
• Create a reference guidelines governance
team. With clear guidelines and standards for
reference library usage, users will be able to
follow a defined path and reduce the chance of
making a mistake. A governance team can then
establish the proper nomenclature to follow
while inputting the information into the system
to maintain standard procedures.
Reference Currency
From there, organizations need to assess
reference currency; in other words, they need
to ensure that purchased assets retain and
deliver value. The following actions are critical to
achieving this:
• Single source: Having a single source of infor-
mation (one copy of a purchased article) is
beneficial, as a purchased article can be used for
multiple references without any recurring cost.
• Avoid duplication: With fewer sources offering
higher accuracy, the chance of purchasing
duplicate reference materials is significantly
reduced. It then becomes significantly easier to
search and find the existing copy of a published
article before purchasing it from outside the
organization.
Assessing the Benefits
In our experience, organizations that have opti-
mized their reference library resources have
saved a significant amount of time and effort, as
well as redirected unnecessary spending back
into the tactics that drive traction in the market-
place. A streamlined reference library process
will provide:
• Standardization: Information entered in
the system will follow certain standards that
are approved for regions/countries. This
improves the global utilization of digital assets
(i.e., reference materials, claims information,
prescribing information, etc.).
3. A global life sciences organization needed a
defined governance and oversight approach for
its reference library system. The business had
many external agencies and partners — as well
as internal brand, legal, medical and regulatory
teams — interacting with its reference library
system on a daily basis.
System stakeholders were not aligned or trained,
and many did not have clear guidance regarding
the expectations for their roles. In addition,
the organization had never conducted an
impact analysis to identify people, process and
technology pain points, as it had left that issue to
the platform provider.
Findings from our reference library assessment
revealed:
• 120-plus regional affiliates.
• 2,000-plus system users.
• 65,000 references.
• No governance team.
• Misalignment of metadata nomenclature with
brands and disease states.
• A duplicate/error rate of almost 50% of all
references.
• Lack of platform provider ownership for
process/system improvement, best practices
training or change management capabilities.
The known cost for reference upload fees was
$2,031,250, based on the following calculation:
• Time for the average user to enter a reference:
15 minutes per document.
• Total time for references upload: 65,000 x 15
minutes = 975,000 minutes, or 16,250 hours.
• Total agency costs for uploading references:
16,250 hours x $125/hour = $2,031,250.
We also uncovered $1,301,852 in additional costs
in the form of reference duplicates and error fees:
• 30,100 duplicate/error references.
• Average cost of $12 per reference.
• $361,200inpurchasingduplicate/errorreferences.
• 30,100 references x 15 minutes/reference
upload = 451,500 minutes, or 7,525 hours.
• Agency fees for uploading duplicate/error
references: 7,525 x $125/hour = $940,625.
• Total uncovered costs: $1,301,852.
With a dedicated reference library service,
however, all 65,000 references could be entered
for 40% of the original cost. This is based on the
following:
• One dedicated reference library manager.
• Three dedicated regional reference librarians.
• A $2 million investment for the entire dedicated
team over seven years.
This serves as one of many examples of how
life sciences companies can identify internal
inefficiencies, implement corrective actions
that address critical operational shortcomings,
ensure regulatory compliance of brand claims,
and establish stringent best practices, as well as
redirect previously wasted spend toward more
impactful activities.
Quick Take
How a Global Life Sciences Player Saves Significant
Time and Money with a Centralized Reference Library
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TEAM LEAD
REFERENCE LIBRARIANS
GLOBALLY SOURCEDON-SITE
PROJECT MANAGER
CLIENT
BUSINESS USER
REFERENCE LIBRARIANS
Reference Librarian Services
Figure 1
• Centralized control: A reference librarian or
a single point of contact for library functions
will not only help in centralizing all library
functions but also control user queries in the
system. Once a meta data governance structure
is implemented, search and the requirement
for new references is optimized, and duplicate
assets are essentially eliminated.
• Cost reduction: With standardized digital
assets and centralized control, resource avail-
ability will improve. This results not only in
avoiding the purchase of duplicate assets but
also in reducing additional effort to acquire
unnecessary materials.
• Reduced time and effort in getting material
into the market: Easier resource availability
will speed the process of promotional material
approval, providing the organization with the
competitive advantage of releasing promotional
materials ahead of its rivals.
Reference Librarian Services:
Structural Requirements
We have found that an optimized reference library
governance team, supported by a dedicated
resource model, ensures the highest reference
currency at the lowest cost of operations (see
Figure 1).