Taking Control of the MLR Review Process

Taking Control of the
MLR Review Process
In today’s increasingly automated, hyper-
connected world, pharmaceuticals
companies must ensure that medical, legal
and regulatory reviews are accurate, efficient,
and risk-averse.
Cognizant 20-20 Insights | March 2017
COGNIZANT 20-20 INSIGHTS

EXECUTIVE SUMMARY
Pharmaceuticals and biotech companies routinely undergo medical, legal, and regulatory
(MLR) review to ensure that their products’ claims, promotions, and training programs are
medically accurate and in compliance with Federal Drug Administration (FDA) standards
and other regulations.
This typically requires enterprises to establish promotional review committees (PRC)
made up of cross-functional teams comprising medical, legal and regulatory experts.
Understandably, PRCs must be extremely knowledgeable and precise; otherwise, drug
companies run the risk of receiving warning letters from the FDA. The MLR process requires
project managers to work closely with reviewers and key stakeholders — from marketing
and advertising agencies to corporate leadership — to ensure that everyone’s voice is
heard. Simultaneously, marketing managers must get their products to market in a timely
manner and avoid delays that can negatively affect financial performance.
Promotional materials target either consumers or healthcare professionals, and are
distributed across various types of media, including print (brochures, posters, banner ads,
flashcards, etc.) and digital (websites, mobile apps, TV commercials, interactive e-mails/
PDFs, etc.).
This white paper explores the different phases of the MLR process and how analytics can be
applied to answer key questions project/brand managers face, such as:
• How much time does it take for promotional material to reach consumers?
• What percentage of these materials is used versus the volume produced?
• What are the process bottlenecks that hold up the distribution of these materials?
• What KPIs should be monitored to help project managers track the material throughout
the process (e.g., at what stage is it stuck in the pipeline? What are the reasons behind
the delay?).
2Taking Control of the MLR Review Process |
Cognizant 20-20 Insights

PROMOTIONAL MATERIAL
REVIEW
The review process for promotional material
typically starts with strategic planning —
progressing through multiple stages over time.
Figure 1 depicts the three broad phases
(upstream, midstream, and downstream)
of promotional material development and
dissemination.
Upstream Phase
This phase starts with strategic discussions
between marketing and leadership teams to
review the market, the brand, and the proposed
product portfolio, then moves to brand
positioning and tactical planning. Once this stage
is completed, organizations usually engage
external agencies to gather ideas and
recommendations for the product portfolio.
Key marketing team members and external
agencies work together to develop project
requirements and timelines based on the tactical
calendar and business goals. Agencies then
create an initial concept, and submit it to the
marketers for their review. Following that step,
the project moves to the next stage for kick-off
with key stakeholders.
Midstream Phase
This phase begins with a kick-off meeting to help
project managers connect with various stake-
holders; introduce the promotion/marketing
initiative; and assess how team members can
leverage their area of expertise. The team
typically includes key personnel from marketing;
project managers; reviewers (medical, legal, and
regulatory); external vendors (print and tech-
nology); senior leadership, and consultants.
Dissecting the Review Process
Strategic
Planning
Engage
Agency /
Initial
Discussion
Initial
Concept
Submitted to
Marketing
Marketing
Reivew
Submit for
Kick-off
Blueprint
Production:
Print or
Digital
Marketing
Review &
Submit
Project
Manager
Reivew
Final
Production
Review of
“Real
Product”
Print /
Digital
Production
Submit
to FDA
Release
to Market
UPSTREAM PHASE
MIDSTREAM PHASE
DOWNSTREAM PHASE
Initial
Kick-off
Medical,
Legal &
Regulatory
(MLR)
Review
Not
Approved
Approved
Ad Agency
Edits
Submit for
Production
Reject
Resubmitted
Figure 1

The purpose is to shares ideas, offer suggestions,
and identify potential challenges/gaps that
could stall or slow the initiative.
Following the kick-off meeting, marketing and
external agency partners typically go through
multiple iterations of the project concept
before presenting it to reviewers for their
respective approvals. Medical, legal, and
regulatory reviewers scrutinize the content of
the material to ensure that it is correct,
consistent, and in line with the rules, regulations,
and FDA guidelines within their area of expertise.
Downstream Phase
At this stage, the vendor submits the blueprint
for print and/or digital for final review and signoff
by the client organization to ensure that all
requested changes have been incorporated. This
usually entails multiple exchanges between the
vendor and the client prior to signoff. Digital
projects typically go through more iterations
before they are submitted to the FDA prior to
hitting the market.
PROBLEM STATEMENT
For pharmaceuticals companies, accelerating
time to market requires a review process that is
informed, cost-efficient and risk-averse.
Typical Challenges
Typically, marketing initiatives are based on an
organization’s requirements or developed in
response to industry dynamics. Nonetheless,
reviewers are often time-challenged due to
industry resource reductions and competing
initiatives that also demand their attention.
In the following pages, we will examine how to
develop and optimize an MLR process that will
have the desired impact and make the most of an
organization’s current resources. Most often, the
number of projects evaluated or conceptualized
at the strategic level declines before the next
stage of project creation and review. Other
projects are shelved before they reach the next
stage of production due to factors such as budget
cuts and market shifts. End users (e.g., sales
representatives, healthcare professionals,
pharmacies, and patients) end up ordering only a
fraction of products produced and stored in
warehouses. This funnel structure (see Figure 4,
page 7) requires several tactical adjustments in
order to deliver the expected outcome.
For pharmaceuticals companies,
accelerating time to market
requires a review process that
is informed, cost-efficient and
risk-averse.

APPLYING AN ANALYTICAL
APPROACH
To address this situation, we recommend a
systematic process for evaluating a project and
plugging in the right parameters at the right time
to achieve a common goal. All key stakeholders
(marketing teams, reviewers, external agencies,
leadership) must be aligned and in place from a
project’s beginning. A thorough analysis of key
areas for improvement must be performed, and
potential bottlenecks identified. To determine
the scope and goals of a project, companies must
define key performance indicators (KPIs), which
will help gauge the effectiveness of their efforts
as they work through the process of preparing
materials for MLR review.
KPIs must be clearly defined and quantifiable, in
line with stated business goals, and easy to
communicate to project teams within and
outside the organization (see Figure 2).
While there are thousands of KPIs to choose
from, many companies find it difficult to select
those that fit the needs of their business and
marketing requirements. Research tells us that
less than 10% of all the metrics that are collected,
analyzed, and reported in businesses are used to
inform decision making. Even worse, 90% of the
metrics produced end up overwhelming decision
makers, who are thirsting for insights.1
Analytics technologies enable companies to
examine and decipher vast amounts of data that
can be used to deepen knowledge, enlighten
decisions, and develop KPIs that suit their precise
requirements. KPIs are defined around the needs
of MLR teams and regularly monitored to help
spot gaps and target opportunities for improving
accuracy and efficiency.
Deﬁne
Analyze
Implement
Measure
Solve
Key
Performance
Indicators
Developing Relevant KPIs
To determine the scope and goals of a project, companies must
define key performance indicators (KPIs), which will help gauge the
effectiveness of their efforts as they work through the process of
preparing materials for MLR review.
Figure 2

Prioritizing KPIs
CREATING MEANINGFUL KPIs
There are numerous KPIs for tracking process
efficiency. Figure 3 lists some of the most
common ones.
These KPIs can help make the entire MLR process
more efficient, and potentially generate more
returns for the business (See Figure 4, page 7).
At the same time, KPIs must be monitored over a
sufficient period, roughly three to six months, to
properly assess their value. Having a
comprehensive view of product KPIs helps
marketers and reviewers streamline project
planning, improve inputs, simplify the review
process, and produce marketing material that is
accurate, relevant and effective.
S No.
Key Performance
Indicators (KPIs)
Description Value-Add
1 Entire Project
Duration
Days to close a project, from initial kick-off to
FDA submission.
Serves as top-level health metric to account
for project duration.
2 Duration by Project
Type
Classification of duration by project type
(e.g., websites, e-mail, marketing collateral).
Predicts project completion based on type.
3 Duration of Each
Stage of the
Process
Classification of project duration at each
step in the review process (e.g., medical,
regulatory, legal review).
Uncovers bottlenecks throughout the
process (high project volumes, changing
priorities, product acquisitions, etc.).
4 Cycles/Churn at
Each Stage
Number of rejections by medical/legal/
regulatory/IT throughout the review process.
Helps assess the bottlenecks that might
delay project completion.
5 Reasons for
Additional Cycles
Number of projects rejected and the reasons
cited by the reviewer.
Helps understand the cause of bottlenecks
(unclear guidance from marketing, incorrect
files, agency errors).
6 Stakeholder
(Internal/External)
Accountability
Assessment of the key stakeholders who are
accountable for rejections at any stage.
Extends accountability to include not only
the marketing team, but also internal/
external parties.
7 Products Produced
& Available in
Inventory
Number and names of products produced
and their availability in the inventory of
internal/external vendors.
Enables the company to keep a close watch
on products in inventory and their
warehousing cost.
8 Products Ordered Number of products ordered by end users
(sales rep, HCP, patient, etc.).
Helps assess actual product utilization.
Figure 3

LOOKING FORWARD
The MLR process depends on balancing the
collective efforts of reviewers, marketing teams,
agencies, and production (print/digital). The goal
is to produce promotional materials that are
accurate, timely, focused, and adaptable for use
in future promotions. In this way, companies can
avoid flooding the market and overwhelming end
users with too much information, and reduce the
workload for reviewers, agencies, sales channels,
and production resources (see Figure 5). This
approach (as detailed in the Quick Take on page
8) allows pharmaceuticals and biotech companies
to leverage their investment in strategic
promotions, assure the quality and integrity of
their product portfolio, bring new products to
market faster, and improve the MLR review
process at every stage.
MLR Review
(n=800)
Marketing Materials
(n=1000)
Produced
(n=500)
KPI 1–6 KPI 7 KPI 8
KPIs measured at each stage
Impact
Ordered
(n=150)
Aligning KPIs & Measurements: The Current Process
Figure 4
MLR Review
(n=500)
Marketing Materials
(n=700)
MoreFocusedMaterials
Produced
(n=300)
Increased
Impact
Ordered
(n=100)
Increased Productivity RAMP
(Reviewers, Agencies, Marketers & Production)
Aligning KPIs & Measurements: The Proposed Solution
Figure 5

QUICK TAKE
Leading Pharma Company Takes Hold
of the MLR Process
The client, a top pharmaceuticals company, utilized a robust promotional/educational
material review process. All materials (brochures, ads, flashcards, rep-education assets,
etc.) from the marketing team required multiple approvals by various groups (medical,
regulatory, legal, compliance, IT) before going live. The client wanted to identify key
bottlenecks and reduce turnaround time initially by one-third and eventually by one-half.
We collaborated with the company to:
• Conduct a comprehensive data analysis, tracking the average duration of the
materials at each stage of the review process using historical data.
• Identify relevant KPIs that could ferret out bottlenecks in the review process.
»» This analysis considered various factors — brand, media type (print vs. digital),
material type (ad board, brochure, flashcards, etc.) — to understand the KPIs from
different perspectives.
• Create an executive-level, interactive dashboard that marketing directors could
use to assess the process month to month.
Because of this analysis, the client can now take advantage of:
• Interactive insights that enable the company’s marketing team to gauge performance
against KPIs and identify obstacles monthly.
• Information that enables the company’s senior leadership to take immediate action
and move projects faster through the review process.
• Reduced turnaround time (TAT) by ~40%.

FOOTNOTE
1
www.ap-institute.com/what-is-a-key-performance-indicator.aspx.
REFERENCES
• http://blog.themsls.org/2014/07/7-essential-considerations-about-promotional-material-review-and-approval/.
• www.pharmexec.com/promotional-review-committees-how-achieve-high-performing-teams-0.
Ketki Gupta
Manager, Cognizant
Analytics & Information
Management Practice
Ketki.gupta@cognizant.com
Ketki Gupta has more than nine years of experience in the field of
analytics for the pharmaceuticals industry. Ketki has worked on
a wide range of analytics projects, including promotion response
modeling, sales force effectiveness, ROI for campaign management,
and speaker program compliance and effectiveness. She also
focuses on consulting and analytics around process efficiencies
in various departments across the pharma industry. She holds a
master’s degree in Applied Operational Research and a bachelor’s
degree in statistics from Delhi University.
ABOUT THE AUTHORS
Saurabh Arora
Senior Associate,
Cognizant Analytics &
Information Management
Practice
Saurabh.Arora2@cognizant.com
Saurabh Arora has more than nine years of experience in consulting
and analytics, solving quantitatively challenging business problems
using advanced analytical tools. Saurabh has worked on a variety
of projects involving operation efficiency analytics (including
MLR review process optimization), market research, marketing
management, regression model monitoring, and sales force sizing
and structure for clients throughout the U.S. and Europe. He holds
an M.B.A. degree from the Indian Institute of Foreign Trade, New
Delhi, and a bachelor’s degree in statistics from Delhi University.

ABOUT COGNIZANT ANALYTICS
Within Cognizant, as part of the social-mobile-analytics-cloud (SMAC) stack of businesses under our emerging business accelerator (EBA),
the Cognizant Analytics unit is a distinguished, broad-based market leader in analytics. It differentiates itself by focusing on topical,
actionable, analytics-based solutions coupled with our consulting approach, IP-based nonlinear platforms, solution accelerators and a
deeply entrenched customer-centric engagement model. The unit is dedicated to bringing insights and foresights to a multitude of industry
verticals/domains/functions across the entire business spectrum. We are a consulting-led analytics organization that combines deep domain
knowledge, rich analytical expertise and cutting-edge technology to bring innovation to our multifunctional and multinational clients;
deliver virtualized, advanced integrated analytics across the value chain; and create value through innovative and agile business delivery
models. www.cognizant.com/enterpriseanalytics.
ABOUT COGNIZANT
Cognizant (NASDAQ-100: CTSH) is one of the world’s leading professional services companies, transforming clients’ business, operating and
technology models for the digital era. Our unique industry-based, consultative approach helps clients envision, build and run more innovative
and efficient businesses. Headquartered in the U.S., Cognizant is ranked 230 on the Fortune 500 and is consistently listed among the most
admired companies in the world. Learn how Cognizant helps clients lead with digital at www.cognizant.com or follow us @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
European Headquarters
1 Kingdom Street
Paddington Central
London W2 6BD England
Phone: +44 (0) 20 7297 7600
Fax: +44 (0) 20 7121 0102
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
© Copyright 2017, 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.
TL Codex 2522

Taking Control of the MLR Review Process

More Related Content

What's hot (20)

Viewers also liked (20)

Similar to Taking Control of the MLR Review Process (20)

More from Cognizant (20)

Taking Control of the MLR Review Process