For life sciences companies, improving risk evaluation and mitigation strategy (REMS) is critical to adhere to FDAAA and other regulatory hurdles; here's our Microsoft SharePoint-based approach for improving document management and sharing and upgrading REMS.
Improving Risk Evaluation and
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.
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
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
• Multiple e-mail threads.
• Complex publishing interfaces with redundant
• Collaboration issues between internal teams
(safety risk directors, medical directors, safety
management team, global program team, etc.)
and external vendors.
• Unstructured discussions through various
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
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
• Cognizant 20-20 Insights
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 ele-
related to a new product or compound.
Multiple teams from within the organization col-
laborate with external vendors to create these
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
• 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
Current REMS Environment
Sharing with External Vendors
Internal Teams External
• Required a continuous overhead of
tracking and collating e-mail contents.
• No single view of responses in a
presentable format for the senior
• 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
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
Proposed Solution Overview
Our 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.
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
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.
>> Reversibility of risk.
Figure 3 illustrates the task flow.
3cognizant 20-20 insights
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
Estimated size of population
likely to use the drug.
of the drug.
potential side effects.
Whether other products in the
same class have REMS.
Core REMS Roles and Responsibilities
REMS CORE TEAM
Identify the factors inﬂuencing REMS requirement.
Prepare recommendations for elements creation.
Send for approval.
Share ﬁnalized approved plan for kickoff.
4cognizant 20-20 insights
• Global pharmaceuticals major with annual
revenues exceeding $55 billion.
• 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
• We partnered with the client to reengineer
the entire process to resolve existing business
• 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.
• 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
• 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.
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
• 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
cognizant 20-20 insights 5
We recommend user authentication with separate
permission sets for the following core committee
• Medical director (colead).
• Safety risk director (colead).
• Global brand regulatory manager/director
• 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,
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
• 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
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
>> 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
>> Moderator-controlled, with a linked survey
option to see which direction the discussion
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
• Document approval workflow: The proposed
document approval workflow is as shown in
Recommended Moderation Process
Create new discussion
Notification sent to admin
Is it a
The user has
Send details to
Notify the user
Post it on the general
Post it on the prodcut
REMS Document Approval Workflow
Actor Input Output Notification
Decision on the REMS
Sent to the vendor with the
details of the document library
to upload the documents.
from the REMS
• 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 Team
Approve/delegate. If approved, workflow ends
Approval mail with
the document link.
Edit/approve/reject comments. Approval/rejection mail sent to
the REMS core team member.
of the REMS
Change the status of the
document to publish as final
copy of REMS.
Blast mail to all product library
cognizant 20-20 insights 7
Document archival workflows: The proposed
document archival workflow is depicted in Figure 7.
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.
The 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-
>> Transparency in business processes, with
defined roles and responsibilities.
>> Early identification of REMS elements
through common discussions open to en-
>> 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.
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.
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.