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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
cognizant 20-20 insights 2
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.).
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
cognizant 20-20 insights 3
cognizant 20-20 insights 4
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).
About Cognizant
Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business
process outsourcing services, dedicated to helping the world’s leading companies build stronger busi-
nesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfac-
tion, technology innovation, deep industry and business process expertise, and a global, collaborative
workforce that embodies the future of work. With over 100 development and delivery centers worldwide
and approximately 244,300 employees as of June 30, 2016, Cognizant is a member of the NASDAQ-100,
the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and
fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant.
World Headquarters
500 Frank W. Burr Blvd.
Teaneck, NJ 07666 USA
Phone: +1 201 801 0233
Fax: +1 201 801 0243
Toll Free: +1 888 937 3277
Email: inquiry@cognizant.com
European Headquarters
1 Kingdom Street
Paddington Central
London W2 6BD
Phone: +44 (0) 20 7297 7600
Fax: +44 (0) 20 7121 0102
Email: infouk@cognizant.com
India Operations Headquarters
#5/535, Old Mahabalipuram Road
Okkiyam Pettai, Thoraipakkam
Chennai, 600 096 India
Phone: +91 (0) 44 4209 6000
Fax: +91 (0) 44 4209 6060
Email: inquiryindia@cognizant.com
­­© Copyright 2016, Cognizant. All rights reserved. No part of this document may be reproduced, stored in a retrieval system, transmitted in any form or by any
means, electronic, mechanical, photocopying, recording, or otherwise, without the express written permission from Cognizant. The information contained herein is
subject to change without notice. All other trademarks mentioned herein are the property of their respective owners.
About the Author
Andrew Isaacs is a Principal in Cognizant’s Analytics & Information Management (AIM) Life Sciences
business unit. He has over 25 years of life sciences experience, focusing on leading global commercial
operations and technology optimization teams, marketing excellence, brand management teams, lifecycle
planning, stakeholder management and governance/change management. Andrew was the commercial
processes and practices lead for a global pharmaceuticals company and chief strategy officer for a life
sciences medical communications agency. He also introduced “marketing excellence” at a global life
sciencescompanyandlaunchedmultipleproductsandservicesandoversightforglobalnewproductdevel-
opment. He has an undergraduate degree in biomedical engineering, an MBA/MS graduate degree and
post-graduate certificates in project management and new product development. He recently authored
multiple thought leadership white papers, including “Accelerating Bio-Pharma’s Marketing Transformation.”
Andrew can be reached at Andrew.Isaacs@cognizant.com.
Acknowledgments
The author would like to thank Harish Kumar, a Senior Business Analyst within the Life Sciences Practice
of Cognizant’s Analytics & Information Management business unit, for his contributions to this white paper.
Codex 2219
Looking Forward
Life sciences organizations must proactively
ensure that investments made to propel the brand
are accurate and aligned with corporate position-
ing and messaging and — importantly — comply
with internal and external audits. Overlooking
these considerations can put the organization at
significant risk, by exposing the brand to potential
reputational damage and the marketing team to
cessation of its initiatives.
In today’s climate of information management
and operational excellence, there is no excuse for
failing to effectively manage the most important
aspects of brand-supportive materials.
Embracing a services-oriented approach to
reference library assessment and support will
enable the following:
•	Highly trained and dedicated reference
librarians who ensure that search, input,
linking and expirations are executed, and
that compliance risk is eliminated, all within
a fraction of the time/cost required for the
typical system user.
•	Multi-regionalcapabilitiesthatenableoptimized
user support, from a rapid turnaround to a local
language requirement PoV.
•	The scalability to meet business-critical and/or
unplanned market events.
•	The ability to leverage a combination of
global resources to tailor support services to
maximize services at reduced costs.

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Promotional References: Assembling Relevance, Ensuring Compliance, Avoiding Unnecessary Spend

  • 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
  • 2. cognizant 20-20 insights 2 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 cognizant 20-20 insights 3
  • 4. cognizant 20-20 insights 4 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).
  • 5. About Cognizant Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the world’s leading companies build stronger busi- nesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfac- tion, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 100 development and delivery centers worldwide and approximately 244,300 employees as of June 30, 2016, Cognizant is a member of the NASDAQ-100, the S&P 500, the Forbes Global 2000, and the Fortune 500 and is ranked among the top performing and fastest growing companies in the world. Visit us online at www.cognizant.com or follow us on Twitter: Cognizant. World Headquarters 500 Frank W. Burr Blvd. Teaneck, NJ 07666 USA Phone: +1 201 801 0233 Fax: +1 201 801 0243 Toll Free: +1 888 937 3277 Email: inquiry@cognizant.com European Headquarters 1 Kingdom Street Paddington Central London W2 6BD Phone: +44 (0) 20 7297 7600 Fax: +44 (0) 20 7121 0102 Email: infouk@cognizant.com India Operations Headquarters #5/535, Old Mahabalipuram Road Okkiyam Pettai, Thoraipakkam Chennai, 600 096 India Phone: +91 (0) 44 4209 6000 Fax: +91 (0) 44 4209 6060 Email: inquiryindia@cognizant.com ­­© Copyright 2016, Cognizant. All rights reserved. No part of this document may be reproduced, stored in a retrieval system, transmitted in any form or by any means, electronic, mechanical, photocopying, recording, or otherwise, without the express written permission from Cognizant. The information contained herein is subject to change without notice. All other trademarks mentioned herein are the property of their respective owners. About the Author Andrew Isaacs is a Principal in Cognizant’s Analytics & Information Management (AIM) Life Sciences business unit. He has over 25 years of life sciences experience, focusing on leading global commercial operations and technology optimization teams, marketing excellence, brand management teams, lifecycle planning, stakeholder management and governance/change management. Andrew was the commercial processes and practices lead for a global pharmaceuticals company and chief strategy officer for a life sciences medical communications agency. He also introduced “marketing excellence” at a global life sciencescompanyandlaunchedmultipleproductsandservicesandoversightforglobalnewproductdevel- opment. He has an undergraduate degree in biomedical engineering, an MBA/MS graduate degree and post-graduate certificates in project management and new product development. He recently authored multiple thought leadership white papers, including “Accelerating Bio-Pharma’s Marketing Transformation.” Andrew can be reached at Andrew.Isaacs@cognizant.com. Acknowledgments The author would like to thank Harish Kumar, a Senior Business Analyst within the Life Sciences Practice of Cognizant’s Analytics & Information Management business unit, for his contributions to this white paper. Codex 2219 Looking Forward Life sciences organizations must proactively ensure that investments made to propel the brand are accurate and aligned with corporate position- ing and messaging and — importantly — comply with internal and external audits. Overlooking these considerations can put the organization at significant risk, by exposing the brand to potential reputational damage and the marketing team to cessation of its initiatives. In today’s climate of information management and operational excellence, there is no excuse for failing to effectively manage the most important aspects of brand-supportive materials. Embracing a services-oriented approach to reference library assessment and support will enable the following: • Highly trained and dedicated reference librarians who ensure that search, input, linking and expirations are executed, and that compliance risk is eliminated, all within a fraction of the time/cost required for the typical system user. • Multi-regionalcapabilitiesthatenableoptimized user support, from a rapid turnaround to a local language requirement PoV. • The scalability to meet business-critical and/or unplanned market events. • The ability to leverage a combination of global resources to tailor support services to maximize services at reduced costs.