Cognizant 20-20 Insights

Improving Risk Evaluation and Mitigation Strategy

By leveraging shared documents and collaborative workflows, life sciences companies can more cost-efficiently and effectively comply with the dazzling array of global regulations that must be met to launch new products.
Executive Summary
Life sciences companies that want to boost their operating efficiency competitiveness need to advance and streamline their risk evaluation and mitigation strategy (REMS) creation practices. We have helped leading industry players overcome numerous dependencies and steep overheads to elevate compliance with industry regulatory requirements while providing an opportunity to improve collaboration and enhance user experience. This white paper explores the industry implications of a REMS overhaul performed at a global pharma major (see sidebar, page 4). Using a solution built on Microsofts SharePoint platform, we helped this client address the following challenges that confound existing REMS systems and processes:

Unstructured

discussions communication channels.

through

various

Since the solution requires the creation, maintenance, periodic review and update of the REMS documents, SharePoint was the obvious choice due to its strong document management and workflow features. With a SharePoint solution, it was easier to create templates required for medical guides for safe use, patient package, communication plan and other supplementary documents. The easy and familiar user interface of SharePoint provides an added benefit of effortless user adoption with increased collaboration. A rationalized solution not only helps in meeting the compliance and governance policies but also helps in expediting the entire process of REMS elements creation. While not all the recommendations covered in this white paper were implemented for the aforementioned client, we have incorporated many of the lessons from this project post-implementation to propose further improvements to the REMS process.

Multiple e-mail threads. Complex publishing interfaces with redundant

applications.

Collaboration

issues between internal teams (safety risk directors, medical directors, safety management team, global program team, etc.) and external vendors.

cognizant 20-20 insights | june 2013

From the Beginning

REMS is required to validate that the benefits of a drug outweighs its side effects. A proper strategy lays down guidelines for the safe uses of a drug and how risks related to its use can be minimized. While for some drugs a precautionary note printed on the label is enough, there are certain other molecules that require a more detailed education is provided to practitioners and end users. The intention is to propagate safe use while keeping the patients informed about the risks. The Food and Drug Administration Amendments Act (FDAAA) endows the FDA with the authority to require REMS from all drug manufacturers. The FDA notes: REMS are required risk management plans that use risk minimization strategies beyond the professional labeling to ensure that the benefits of certain prescription drugs outweigh their risks.1 REMS may be required by the FDA as part of the approval of a new product, or for an approved product, when new safety information arises. Essentially, REMS helps life sciences companies safely manage a known or potential serious risk associated with a medicine and to enable patients to have continued access to such medicines by managing their safe use. Since each product is unique, the REMS creation process is an extensive exercise in terms of time and resources. It follows a complete project management cycle with collaborative efforts from multiple teams.

REMS Business Challenges

REMS necessitates the creation of specific elements2 related to a new product or compound. Multiple teams from within the organization collaborate with external vendors to create these elements. This requires that life sciences companies form a core REMS team to create a plan for publishing REMS documents on the FDA site for new products in their portfolios. Currently, this process is conducted primarily through the exchange of e-mails and Microsoft Excel-based models to track activity milestones. Document exchange happens through file sharing for internal teams, and other nonsecure channels for external vendors. This requires dedicated resources to continuously follow e-mail trails and processes. Manual intervention negatively affects resource utilization and timely delivery of elements, apart from managing regulatory compliance. Figure 1 depicts a typical REMS process leveraging traditional tools. After carefully evaluating the REMS creation process, we identified the following collaboration needs:

General process and procedure discussion. REMS assessment discussion. REMS creation, review/approval and publishing. Version control and audit trails. Archiving rules. Interfacing with external systems such as a
clinical research documentation and information system (CREDI).

Current REMS Environment

Communication/Document Sharing with External Vendors

E-mail to Assess REMS Requirement Core Team Members Multiple Response Chains/Threads Internal Teams

Intergroup Discussions Communication/ Document Sharing with External Vendors

External Vendors

Required a continuous overhead of

tracking and collating e-mail contents.

Lack of discussion forum

for the internal users led to multiple e-mail threads.

Sensitive information
ow through e-mails.

No single view of responses in a

presentable format for the senior management.

No common collaboration platform

for elements creation.

No single decision point. Lack of transparency.

Lack of process
automation led to delay in elements creation.

Figure 1

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3

Core REMS Roles and Responsibilities

REMS core team formation typically starts 12 months prior to launch of REMS.
Safety Director/Safety Risk Director

Assess FDA request.

Identify the stakeholders to form the core team and support teams.

Dene goals and objectives of the REMS.

Get go-ahead approval from the regulatory board.

Estimated size of population likely to use the drug. Expected benets of the drug. Seriousness of potential side effects. Whether other products in the same class have REMS.

Figure 2

These requirements made a strong business case for a unified solution to ease the REMS coordination process. We immediately saw how a SharePoint-based portal solution could deliver numerous benefits to life sciences companies while addressing the compliance requirements of the FDAAA.

recommends the development of a prototype with exhaustive mapping of major processes, as first steps towards definition of the REMS creation process. Our recommended approach is as follows: 1. Build a REMS core team: Figure 2 illustrates the composition of the REMS core team. 2. Conduct elements discovery: The core team internally identifies the various elements required for the REMS depending on factors such as:

Proposed Solution Overview

Our recommended solution uses the collaboration and document management features of SharePoint to build a platform designed to effectively automate the business processes and streamline the entire lifecycle of REMS elements creation. Process Mapping Our solution contains numerous components designed to optimize key business processes. As such, our solution segregates business functional requirements from technical components. It also

>> Benefits vs. severity. >> Incidence. >> Predictability. >> Reversibility of risk.
Figure 3 illustrates the task flow.

Core REMS Roles and Responsibilities

REMS CORE TEAM Safety Management Team Identify the factors inuencing REMS requirement. Prepare recommendations for elements creation. Send for approval. Share nalized approved plan for kickoff.
Global Program Team

Figure 3

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The outcome of this internal discussion between the core team and internal teams is proposed REMS elements and is further sent for approval to the safety and review board. 3. REMS Project kickoff: The core REMS team then works toward writing a project plan for the elements creation. This may include:

Feature Mapping Once the business processes are defined, the next step is to map them to solution components. Our recommended feature mapping is depicted in Figure 4 (on next page). Critical solution components include:

User authentication and single sign-on (SSO) A

Medical guide. Patient package insert. Communication plan. Elements to ensure safe use. Implementation plan. Information needed for assessment. Timetable for assessment.
For any product, it is not necessary to create the entire set of aforementioned documents. The element discovery discussion between the core team, safety management team and program management team is the key to identify which REMS elements are necessary for any product in the portfolio.

for the internal users and secure extranet access to the partner vendors. general discussion platform for initial REMS general policy and procedure-related discussion. for content relevance and authorization.

The ability to moderate the discussion forum A A A

document repository with advanced workflows for approvals and routing. project server integration for tracking REMS projects (such as our recommended Microsoft Project Server). dashboard with information about all the ongoing REMS creation projects and their related statuses.

Quick Take
Big Pharmas REMS Makeover
Client:

Global pharmaceuticals major with annual revenues exceeding $55 billion.

Business Situation:

A SharePoint platform was deployed to unify

The

clients REMS team leveraged traditional tools such as e-mails and file sharing as primary modes of collaboration with vendors to define the procedures and forms. to standardization of processes, ineffective collaboration and inability to get a consolidated status.

work conducted by the REMS core safety management and global program teams, as well as with external vendors, enabling tighter internal collaboration for the creation and publishing of REMS and RMP documents.

Benefits:

The approach had inherent challenges related

Solution:

We

partnered with the client to reengineer the entire process to resolve existing business challenges.

Effective REMS management. Streamlined processes. Improved collaboration. Effective document management. Better compliance. Improved user experience.

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Mapping Key Processes

REMS Core Team

External Vendors

Safety Management Team

Global Program Management Team

Secure authentication (SSO for internal employees connecting through corporate LAN/dual authentication for external vendors.)

General discussion board to assess REMS elements and policies and procedures. Moderator controlled to distinguish general and project-specific forum. Integrated with survey to get a sway of the discussion. Project-specic discussion forum with exclusive access to the product team. Workow to move a project-specic discussion from the general forum to the product page. Moderator controlled, with the ability to hide the entire forum once the REMS is nalized. Dened product libraries with document management features. Workow trigger for action groups based on status changes. Interfacing with other applications for approval and publishing. Auto-archiving rules based on the business group record management policies. Project dashboard to provide a dynamic view of all ongoing projects. Linked to metadata to capture details such as project status, effort estimation, risk tracking, etc.
Figure 4

User Authorization We recommend user authentication with separate permission sets for the following core committee members:

Discussion Platform with Linked Survey, Dashboard The solution requires two discussion forums: one for general discussion and another for productspecific discussions. Both discussion forums which are moderator-based must have linked workflows and surveys.

Medical director (colead). Safety risk director (colead). Global brand regulatory manager/director
(GBRM/D).

General discussion forum:

The general discussion forum is used primarily for discussions around policies, events and other general topics. It is moderator-controlled, and users are redirected to the product page for any product-specific discussion. The recommended moderation process is illustrated in Figure 5 (next page).

Global drug safety and epidemiology (DS&E) brand safety leader (BSL). DS&E medical safety expert. Brand director. Legal counsel.
Apart from these roles, product groups need to be defined, and the option to dynamically link an external vendor to the product group, with limited permissions, also has to be available to product managers. Since the solution requires collaboration between internal teams and external partner vendors, form-based authentication can be used to provide a secure external interface.

Product discussion forum:

The product discussion forum is specifically used for the REMS creation process/planning for any product in the portfolio. The highlights of the solution are:

>> Material is kept hidden on the product page

until the product manager decides to initiate a new discussion.

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Recommended Moderation Process

Create new discussion Send details to product team

Notification sent to admin

Is it a general discussion?

The user has access permissions for product library

Notify the user about access conflict

Y
Post it on the general discussion forum

Y
Post it on the prodcut discussion forum

Figure 5

>> Metadata tags to capture the status of the >> Ability to move a discussion to the general
forum or to another product page.

Document Libraries with Advance Workflows REMS document libraries are implemented with e-mail notification, document approval and document archival workflows. Provisions to autocreate a document library from the discussion closure page lead to simplification of processes and reduced user effort. A custom component to suspend a workflow and resume it from the next pending user approval is also a part of the solution.

discussion (active/suspended/closed) for reporting purposes.

>> Advance notification capabilities: Once the

discussion closes, the product manager can select the components to be created and send the notification to vendors to work on the templates. option to see which direction the discussion is swaying.

>> Moderator-controlled, with a linked survey

REMS Document Approval Workflow
Actor REMS Core Team Member Vendor/REMS Core Team Member Core REMS Team Delegate-> Members Core REMS Team Member
Figure 6

Document

approval workflow: The proposed document approval workflow is as shown in Figure 6.

Input
REMS assessment discussion thread summary. E-mail notification from the REMS team.

Output
Decision on the REMS documents required.

Notification
Sent to the vendor with the details of the document library to upload the documents. Sent to core REMS team.

Create the documents. Upload in the product REMS

document library (core REMS team member can upload previously published docs before this site is set up). If approved, workflow ends here. Approval/rejection mail sent to the REMS core team member. Blast mail to all product library users.

Core REMS document. Approval mail with the document link. Approved version of the REMS document.

Approve/delegate. Edit/approve/reject comments.

Change the status of the document to publish as final copy of REMS.

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Archival Workflow
Actor: System Admin

Set the path for the document archive folder and rule for all libraries (one year as the standard). Download a copy of document. Send e-mail notification to the document owner one week prior to expiring (action required would be to upload a new copy of the document to nullify the one year period). Delete exisiting document site. Upload the copy, the new expiry date will not be reset again to one year.

Run a batch job to move all expired documents to archive folder.

Archive folder will have all the documents in archive mode for reference purpose only. There will not be any transactional operation possible on them. This approach will help set rules site-wise with a single person controlling it.

Figure 7

Document archival workflows: The proposed document archival workflow is depicted in Figure 7. Dashboard Dictates To provide real-time status reports, we suggest a dashboard feature with the following capabilities:

>> Transparency >> Early

in business processes, with defined roles and responsibilities. identification of REMS elements through common discussions open to entire community. dynamically updated dashboards.

Show the status of all ongoing projects. Show the vendor load at any given time. Depict important milestones. Reflect the weekly ongoing discussions.
Conclusion
The proposed solution provides unmatched capabilities for the REMS team to collaborate while following best practices. Our solution improves the efforts required for REMS creation. Some immediate benefits generated include:

>> Early identification of project risks through >> Scalable,

with an option to add more product hierarchies as and when needed through the user interfaces.

Administrative benefits: >> Improved efficiency of project resources. >> Reduced e-mail traffic. >> Easy tracking of document access log. >> Easy-to-generate reports on vendor utilization with real-time data.

Business benefits: >> Faster time-to-market

of the entire process.

>> Easy transmission of documents to relevant

through expedition groups, sharing of information through common alerts to groups, collection of feedback and obtaining of approvals.

>> Facilitated

higher collaboration through joint authoring, review and real-time communication.

Footnotes
1 2

Authorized by the Food and Drug Administration Amendments Act of 2007 (FDAAA). Elements are specific documents targeted at people who use the drug. It can be a medical guide, patient package, specified dosages, side effects, etc.

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References

Approved

Risk Evaluation and Mitigation Strategies (REMS), US Food and Drug Administration, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ ucm111350.htm#information. Workshop, 6/7/2012, http://www.fda.gov/Drugs/NewsEvents/ucm292337.htm.

REMS Assessments: Social Science Methodologies to Assess Goals Related to Knowledge: Public Format
and Content of Proposed REMS, REMS Assessments, and Proposed REMS Modifications Guidance for Industry, 9/2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM184128.pdf.

About the Authors

Dipti Rai is a Consultant in Cognizants Enterprise Content Management and Portals Business Unit. In this role, she is actively involved in implementation of successful portal solutions, with an emphasis on information architecture, governance and business values metrics. Apart from consulting, Dipti is also involved in creating business solutions for presales responses. She also drives practice level initiatives for nonlinear revenue growth. Dipti has over four years of experience in the IT industry. She holds a B.Tech. in computer science and a post-graduate diploma in management from Great Lakes Institute of Management. She can be reached at Dipti.Rai@cognizant.com | LinkedIn: http://www.linkedin.com/in/diptirai.

Vishal Mehta is the SharePoint Consulting Lead at Cognizant, responsible for business consulting and the business development function for the SharePoint Practice. His experience and passion lies in helping organizations leverage disruptive transformations (i.e., social media, mobility, rich videos and cloud) to deliver business value. Vishal has six years of consulting experience in the ECM space. He holds a bachelors degree in computer science from Mumbai University and a masters degree in management from JBIMS. He can be reached at Vishal.Mehta@cognizant.com | LinkedIn: http://in.linkedin.com/in/ vishalkmehta.

About Cognizant
Cognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process outsourcing services, dedicated to helping the worlds leading companies build stronger businesses. Headquartered in Teaneck, New Jersey (U.S.), Cognizant combines a passion for client satisfaction, technology innovation, deep industry and business process expertise, and a global, collaborative workforce that embodies the future of work. With over 50 delivery centers worldwide and approximately 162,700 employees as of March 31, 2013, 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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