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Improving Risk Evaluation and Mitigation StrategyBy 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 SummaryLife 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 implica-tions of a REMS overhaul performed at a global pharma major (see sidebar, page 4). Using a solution built on Microsoft’s SharePoint platform, we helped this client address the following challenges that confound existing REMS systems and processes:
• 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.
• Unstructured discussions through various communication channels.
Since the solution requires the creation, mainte-nance, 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 aforemen-tioned client, we have incorporated many of the lessons from this project post-implementation to propose further improvements to the REMS process.
• Cognizant 20-20 Insights
cognizant 20-20 insights | june 2013
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From the BeginningREMS 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 ele-ments2 related to a new product or compound. Multiple teams from within the organization col-laborate 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 inter-vention 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 informa-tion system (CREDI).
cognizant 20-20 insights
Figure 1
Current REMS Environment
3
Intergroup Discussions
Communication/Document Sharing with External Vendors
Internal Teams External Vendors
• Required a continuous overhead of tracking and collating e-mail contents.
• No single view of responses in a presentable format for the senior management.
• No common collaboration platform for elements creation.
• Lack of discussion forum for the internal users led to multiple e-mail threads.
• No single decision point.
• Lack of transparency.
• Sensitive information flow through e-mails.
• Lack of process automation led to delay in elements creation.
Multiple Response Chains/Threads
E-mail to Assess REMS Requirement
Core Team Members
Communication/Document Sharing with External Vendors
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.
Proposed Solution OverviewOur recommended solution uses the collaboration and document management features of Share-Point 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
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:
> Benefits vs. severity.
> Incidence.
> Predictability.
> Reversibility of risk.
Figure 3 illustrates the task flow.
3cognizant 20-20 insights
Figure 2
Core REMS Roles and Responsibilities
Safety Director/Safety Risk Director
Assess FDA request.
REMS core team formation typically starts 12 months prior to launch of REMS.
Get go-ahead approval from the regulatory board.
Define goals and objectives of the REMS.
Identify the stakeholders to form the core team and
support teams.
Estimated size of population likely to use the drug.
Expected benefits of the drug.
Seriousness of potential side effects.
Whether other products in the same class have REMS.
Figure 3
Core REMS Roles and Responsibilities
REMS CORE TEAM
Identify the factors influencing REMS requirement.
Prepare recommendations for elements creation.
Glo
bal
Pro
gra
m T
eam
Saf
ety
Man
agem
ent
Tea
m
Send for approval.
Share finalized approved plan for kickoff.
4cognizant 20-20 insights
Quick Take
Client:
• Global pharmaceuticals major with annual revenues exceeding $55 billion.
Business Situation:
• The client’s REMS team leveraged tradition-al tools such as e-mails and file sharing as primary modes of collaboration with vendors to define the procedures and forms.
• The approach had inherent challenges related to standardization of processes, ineffective col-laboration and inability to get a consolidated status.
Solution:
• We partnered with the client to reengineer the entire process to resolve existing business challenges.
• A SharePoint platform was deployed to unify 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:
• Effective REMS management.
• Streamlined processes.
• Improved collaboration.
• Effective document management.
• Better compliance.
• Improved user experience.
Big Pharma’s REMS Makeover
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:
• 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.
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) for the internal users and secure extranet access to the partner vendors.
• A general discussion platform for initial REMS general policy and procedure-related discussion.
• The ability to moderate the discussion forum for content relevance and authorization.
• A document repository with advanced workflows for approvals and routing.
• A project server integration for tracking REMS projects (such as our recommended Microsoft Project Server).
• A dashboard with information about all the ongoing REMS creation projects and their related statuses.
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User Authorization
We recommend user authentication with separate permission sets for the following core committee members:
• Medical director (colead).
• Safety risk director (colead).
• Global brand regulatory manager/director (GBRM/D).
• 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 collabora-tion between internal teams and external partner vendors, form-based authentication can be used to provide a secure external interface.
Discussion Platform with Linked Survey, Dashboard
The solution requires two discussion forums: one for general discussion and another for product-specific discussions. Both discussion forums — which are moderator-based — must have linked workflows and surveys.
• 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 recom-mended moderation process is illustrated in Figure 5 (next page).
• 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 initi-ate a new discussion.
Mapping Key Processes
Figure 4
• Moderator controlled to distinguish general and project-specific forum.
• Integrated with survey to get a sway of the discussion.
• Project-specific discussion forum with exclusive access to the product team.
• Workflow to move a project-specific discussion from the general forum to the product page.
• Moderator controlled, with the ability to hide the entire forum once the REMS is finalized.
• Project dashboard to provide a dynamic view of all ongoing projects.
• Defined product libraries with document management features.
• Workflow 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.
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.
• Linked to metadata to capture details such as project status, effort estimation, risk tracking, etc.
cognizant 20-20 insights 6
> Metadata tags to capture the status of the discussion (active/suspended/closed) for reporting purposes.
> Ability to move a discussion to the general forum or to another product page.
> 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.
> Moderator-controlled, with a linked survey option to see which direction the discussion is swaying.
Document Libraries with Advance Workflows
REMS document libraries are implemented with e-mail notification, document approval and document archival workflows. Provisions to auto-create 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.
• Document approval workflow: The proposed document approval workflow is as shown in Figure 6.
Recommended Moderation Process
Create new discussion
Notification sent to admin
Is it a general
discussion?N
Y Y
NThe user has
access permissions for product
library
Send details to product team
Notify the user about access
conflict
Post it on the general discussion forum
Post it on the prodcut discussion forum
Figure 5
Figure 6
REMS Document Approval Workflow
Actor Input Output Notification
REMS Core Team Member
REMS assessment discussion thread summary.
Decision on the REMS documents required.
Sent to the vendor with the details of the document library to upload the documents.
Vendor/REMS Core Team
Member
E-mail notification from the 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).
Sent to core REMS team.
Core REMS TeamCore REMS document.
Approve/delegate. If approved, workflow ends here.
Delegate-> Members
Approval mail with the document link.
Edit/approve/reject comments. Approval/rejection mail sent to the REMS core team member.
Core REMS Team Member
Approved version of the REMS document.
Change the status of the document to publish as final copy of REMS.
Blast mail to all product library users.
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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:
• Show the status of all ongoing projects.
• Show the vendor load at any given time.
• Depict important milestones.
• Reflect the weekly ongoing discussions.
ConclusionThe proposed solution provides unmatched capa-bilities for the REMS team to collaborate while following best practices. Our solution improves the efforts required for REMS creation. Some immediate benefits generated include:
• Business benefits:
> Faster time-to-market through expedition of the entire process.
> Facilitated higher collaboration through joint authoring, review and real-time com-munication.
> Transparency in business processes, with defined roles and responsibilities.
> Early identification of REMS elements through common discussions open to en-tire community.
> Early identification of project risks through dynamically updated dashboards.
> 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 utiliza-tion with real-time data.
> Easy transmission of documents to relevant groups, sharing of information through common alerts to groups, collection of feedback and obtaining of approvals.
Archival Workflow
Actor: System Admin
Set the path for the document archive folder and rule for all libraries (one year as the standard).
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).
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.
Download a copy of document.
Delete exisiting document site.
Upload the copy, the new expiry date will not be reset again to one year.
Figure 7
Footnotes1 Authorized by the Food and Drug Administration Amendments Act of 2007 (FDAAA).
2 Elements are specific documents targeted at people who use the drug. It can be a medical guide, patient package, specified dosages, side effects, etc.
About CognizantCognizant (NASDAQ: CTSH) is a leading provider of information technology, consulting, and business process out-sourcing services, dedicated to helping the world’s 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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© Copyright 2013, 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 AuthorsDipti Rai is a Consultant in Cognizant’s 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 [email protected] | 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 bachelor’s degree in computer science from Mumbai University and a master’s degree in management from JBIMS. He can be reached at [email protected] | LinkedIn: http://in.linkedin.com/in/vishalkmehta.
References
• Approved Risk Evaluation and Mitigation Strategies (REMS), US Food and Drug Administration, http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm111350.htm#information.
• REMS Assessments: Social Science Methodologies to Assess Goals Related to Knowledge: Public Workshop, 6/7/2012, http://www.fda.gov/Drugs/NewsEvents/ucm292337.htm.
• Format and Content of Proposed REMS, REMS Assessments, and Proposed REMS Modifications Guidance for Industry, 9/2009, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulato-ryInformation/Guidances/UCM184128.pdf.
