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 SummaryWhen 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.

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• Cognizant 20-20 Insights

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Reference Library Assessment: Getting StartedA 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.

• $361,200 in purchasing duplicate/error references.

• 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 RequirementsWe 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 CognizantCognizant (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.

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© 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 AuthorAndrew 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 sciences company and launched multiple products and services and oversight for global new product devel-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.

AcknowledgmentsThe 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.

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Looking ForwardLife 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-regional capabilities that enable optimized 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.