Bridging Gaps in

Pharmacovigilance
With Social Media Listening
And Competitive Intelligence
About Digimind
Digimind is the leading social media monitoring and competitive intelligence software, designed for brands and agencies who want to
accelerate digital transformation through an insights-driven approach. Recognised by Forrester and Gartner, Digimind’s best-in-breed
technology transforms social and online data into actionable business insights, enabling marketers to effectively plan, execute, and
analyse their marketing strategy.

Founded in 1998, Digimind is headquartered in New York, Paris, Singapore, and Rabat, serving more than 600 customers worldwide
including LinkedIn, Sony, McCann Worldwide, and Lexus.

More information on www.digimind.com

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Want to know more about Digimind and how our best in

breed social listening and analytics technology can help
boost your product development and launch strategies?

Contact Us: marketing@digimind.com

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Introduction
What is pharmacovigilance?
Pharmacovigilance (PV) has evolved significantly since it was first
implemented by the World Health Organization (WHO) in 1961, in
response to the thalidomide disaster. Thousands of babies worldwide
were born with malformed limbs due to mothers consuming this
mild sleeping pill, which was marketed as safe during their
pregnancies. To avoid similar disasters from happening, rigorous
testing and monitoring of every new drug before and after its release
became mandatory.

PV is defined by the WHO as the science and

activities relating to the detection, assessment,
understanding, and prevention of adverse
effects or any other drug-related problem.

As of 2019, 136 countries are full members of the WHO PV

Program¹, with 29 associate member countries preparing
themselves for full membership. Overall, the key aim of PV is to
enhance the safety and efficacy of drug use, through identifying,
assessing, understanding, managing, and preventing adverse effects
of medicines.

www.digimind.com 1. Uppsala Monitoring Centre, Members of WHO programme, 2019 3

Introduction
Differing Regulatory Landscapes + Social Media = A Complex Recipe?
As PV structures change and stricter guidelines are imposed across different countries at varying rates, drug safety monitoring
has grown significantly more complex and time consuming.

Furthermore, the rise of the Internet and social media has given consumers a newfound wealth of choice and autonomy about
treatment options. Patients now have unprecedented access to information about different types of drugs and treatments, as well as
the potential risks associated with new ones.

With people taking to the Internet to share personal experiences and opinions about the medicines they use, brands and
pharmacovigilant services also have a new channel to monitor drug use to gather important insights on drug consumption and
adverse drug reactions (ADRs). Pharmaceutical companies are faced with increased vulnerabilities to their online reputation, as
social media networks and forums facilitate the rapid spread of information and opinions about drug use and adverse events.

It is not only beneficial, but necessary to deploy a

social media listening and competitive intelligence
This eBook will guide you
(CI) tool to help you gather and analyze vast
amounts of information, thereby safeguarding your
through:
online reputation and competitiveness.
● An overview of PV activities in Asia Pacific (APAC), Europe,
United States of America (USA), and Latin America
(LATAM)
● Drug safety monitoring before and after the launch of a
new drug in the market
● Key uses of social media for the pharmaceutical industry
● How to deploy a social media listening strategy and CI
project to ensure the efficacy of PV activities

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 Pharmacovigilance
and Adverse Event
Reporting

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Pharmacovigilance and Adverse
Event Reporting
A reportable adverse reaction (AE)2 constitutes any untoward Countries with well-developed national PV centres3 which are
medical occurrence that may present during treatment with backed by a medicine regulatory authority (MRA), have:
a health product, such as western drugs, vaccines, biologics, - Well-structured PV programs and dedicated staff for
medical devices, complementary medicine or cosmetics, but disease specific programs
which does not necessarily have a causal relationship with - Accurate and unbiased information directed at both
this treatment. prescribers and patients
- A well-resourced health agency that can assess
It should have four basic criteria: information supporting the quality, safety, and efficacy
of medicines
An identifiable
patient A specific symptom Those that lack well-established or resourced MRAs, may
or effect not require assistance from regulatory agencies and experts from
caused by more advanced countries.
An identifiable
accidental or - Public health departments may employ the same staff
reporter
deliberate to manage different disease programs
overdoses and - PV centres may be rudimentary or absent entirely
A specific drug medication errors - Patients may not have access to information about
medicines, even WHO prequalified products

Depending on the structure of public health departments at a

Regardless, it is important to have a well-structured
district, state, or country level, national PV centres may be
and adequately backed procedure for reporting and
centralized or decentralized.
mitigating the circulation of products that do not
meet pharmacopoeial standards.

2. Health Sciences Authority, Report Adverse Event Related to Health Products, 21 Feb 2019
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3. World Health Organization, Global Meeting of Emergency Medical Teams, 2019
 PV Legislation by Region - APAC

Worth over $140 billion4 and projected to grow at an annual rate of 9.1% from 2017 – 20215,
the APAC pharmaceutical industry is the third largest in the world after North America and Europe. However, diverse PV systems
and an overall lack of standardization creates several complexities for pharmaceutical companies. This is further exacerbated by
differing levels of economic growth in each country.

Out of ten countries in the ASEAN region,

● Nine have a national policy or legal framework for implementing PV, and are members of the WHO Program for IDM
● Eight make it mandatory for companies holding licenses for pharmaceutical products, to regularly report about their side
effects to authorities

4. US National Library of Medicine National Institutes of Health, Pharmacovigilance in Asia, Dec 2013
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5. Brink News, How To Ensure Safe Medicines in Asia, 25 May 2018
 PV Legislation by Region - APAC
Country PV structure
● Voluntary reporting through healthcare
practitioners (HCPs) in hospitals and public
health centers, general and private practices,
pharmacies, and other HCPs
● Authorities are undertaking efforts to
strengthen the PV legal framework and
strengthen risk management programs
● Run by the Malaysian Adverse Drug
Reaction Adverse Committee (MADRAC)
● The Health Sciences Authority (HSA)
appointed a Pharmacovigilance Advisory
Committee (PAC) to assess the impact of
major drug safety issues and advise on the
appropriate regulatory actions to be taken
● The ADR reporting system was established
in August 1994 by the Bureau of Food and
Drugs (BFAD) with a primary focus on case
reports, health advisory, and preemptive
warnings to HCPs and the public
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PV requirements
● Mandatory reporting done by HCPs voluntarily
submitting a form to the Council for International
Organizations of Medical Sciences (CIOMS)
● Pharmaceutical companies should have a designated
unit for PV
● Registration holders who have registered a product
containing a new chemical entity (NCE) after 1 January
2002 must routinely submit Periodic Safety Update
Reports (PSURs) on that product every 6 months for the
first 2 years after approval, and annually for the
subsequent 3 years
● PSURs are required to be submitted to the Product
Evaluation and Registration Branch (PERB), bimonthly
for the first two years after marketing approval, after
which they are to be submitted on a yearly basis for the
subsequent three years
● These reports may be requested for selected registered
medicinal products
● Adverse events are either unrecognized, or
misconstrued as part of the healing action by
practitioners of folk medicine, who are unlikely to report
them
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 PV Legislation by Region - European Union (EU)
The foundations of the EU’s PV system can be traced back to 19766, to the first EU legislation on medicines. In 2005, the
European Commission (EC) began a review of the European system of safety monitoring; extensive public consultation in 2006
and 2007 led to the adoption of a new legislation in December 2010. European legislation entered into practice in July 2012,
with further enhancements introduced in 2017.

The overall goals of the EU’s PV system are health promotion and health protection, with European
Medicines Agency (EMA) / Pharmacovigilance and Risk Assessment Committee (PRAC) assessment and
recommendations put in place during pre and post launch stages.

6. European Medicines Agency, Overview of the EU Pharmacovigilance System, 9 Mar 2019

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 PV Legislation by Region - European Union (EU)

Together, the national PV systems of the member states make up the EU’s PV system. This system cooperates in a network
structure under the coordination of the EMA, and in association with the European Commission (EC). Each country is
responsible for monitoring the safety profile of a product in its territory and taking action when necessary.

EMA

● 7 scientific committees (CHMP, CVMP,

European Medicines COMP, HMPC, PDCO, CAT, and PRAC)
Regulatory Network ● 28 WPs
● ~ 4000 scientific experts across the EU

National
CAs (from European
31 EEA MSs) Commission

In France, activities carried out by drug companies take place under a very strict framework imposed by the public health
code. As a result, manufacturing, importing, exporting, and distribution of drugs can only be carried out by pharmaceutical
institutions.

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 Pharmacovigilance in the Pre-Launch Phase -France
DEVELOPMENT SURVEILLANCE

Pre-Clinical Research Authorization

Development of the
molecule in the Committees for the National Agency for the
laboratory and Protection of Persons Safety of Medicines and
toxicology studies before
(CPP) give opinions Health Products issues
testing on human
an authorization
subjects

1st security profile

Clinical Trials Commission of the AMM
Established by
the laboratory
and deduced
Group #1: based on adverse Issue market
Healthy effects authorization
individuals

Risk management plan

Group #2: Established by

Afflicted the laboratory Risks and benefits
individuals at the request analysis
of authorities

Group #3:
Large
population of AMM
patients Authorization to place the product on the
market specifying adverse effects, indications,
and precautions
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 Pharmacovigilance in the Post-Launch Phase - France
Spontaneous Notifications

Two third of
notifications:
Patients and Laboratory
patient pharmacovigilance
associations service

Proposal to
Medical modify the Commission of the
visitors information of AMM
medicines
Health
professionals One third of
notifications:
Regional Transfer of opinion
Patients can directly report pharmacovigilance
adverse effects to healthcare centres
professionals via the website of
their choice

trades Director
SURVEILLANCE National Agency for the Safety of
General of
ANSM
Decision
Medicines and Health Products
Suspension
Withdrawal
Retention

VS VS Transfer of opinion

Comparing the appearance of a Comparing disease cases with a

pathology appearing in two groups healthy control group to identify risk National
of people in relation to a risk factor factors Pharmacovigilance
Commission

Epidemiological Studies
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 PV Legislation by Region - United States of America (USA)

The Food and Drug Administration (FDA)7 is responsible for protecting and promoting public health through the control
and supervision of multiple categories of consumer products, including dietary supplements, prescription and
over-the-counter pharmaceutical drugs, vaccines, and medical devices.

The FDA Adverse Event Reporting System (FAERS) is used to:

Support post-marketing
Identify new safety concerns Evaluate drug manufacturers’
safety surveillance programs
that might be related to a compliance with reporting
for drug and therapeutic
marketed product regulations
biologic products

The FDA receives voluntary reports from healthcare professionals, consumers, and manufacturers. Manufacturers are also
required to send reports submitted by healthcare professionals and consumers to them about their products.

7. Food and Drug Administration, Questions and Answers on FDA's Adverse Event Reporting System, 6 April 2018
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 PV Legislation by Region - United States of America (USA)

How Drug Postmarketing Reports Get to the FDA However, the FAERS’ ability to calculate the incidence
of an adverse event in the US population is limited by:
- Lack of requirement by the FDA for a causal
Patients, Consumers & relationship between a product and event to be
Healthcare Professionals proven
- Not all adverse events being reported, due to
the time a product has been marketed or
publicity about the event
Voluntary Voluntary
With a more recent initiative called the Sentinel
System – a national integrated electronic system for
monitoring drug safety through shared healthcare
FDA MedWatch Manufacturer
databases.

Sentinel takes advantage of “big data” and various

5% of all Regulatory networks across data partnerships to detect and
reports Requirements manage emerging risks that are associated to FDA
regulated products – allowing evaluation of drug safety
issues much more rapidly than before. As this is an
active digital surveillance program focused on
recognizing and analyzing drug safety issues, Sentinel
FAERS 95% of all allows the FDA to proactively assess safety with
FDA
Database reports real-world conditions which compliments other efforts
such as FAERS.

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 PV Legislation by Region - Latin America (LATAM)
The LATAM PV system developed considerably since the early 1900s and has continued to strengthen within the last
decades. Dealing with mostly emerging markets, the PV regulatory requirements governing these countries vary quite a bit.
When approaching pharmaceutical drug products,

Approximately 16 countries have set up modalities of

immediate reporting of adverse effects

9 have implemented modalities of periodic reporting

of AEs

6 countries have established specific requirements

for AEs as it relates to vaccines

As the implementation of PV programs is relatively recent in LATAM compared to other regions in the world, the PV
programs in LATAM will have to be more proactive than reactive against the ever changing legislation in the region and
withdrawals of medicines from the market, while generating and encouraging cooperation for the development and
expansion of a functioning LATAM network of PV.

As of now, there is no Latin American equivalent to the EMA- no common body with power to facilitate PV regulation across
all countries. Currently, the WHO’s Pan American Network for Drug Regulatory Harmonization seeks to assist Latin American
countries to develop a harmonized PV.

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 The Value of Social
Media and Analytics
to Pharmacovigilance

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Evolving Brand-Customer Relationships on Social Media

Traditionally, post market surveillance
(PMS) has consisted primarily of
notifications from healthcare
professionals, drug companies, regional
PV centers, and epidemiological studies.
Pharmaceutical companies rely mostly
on healthcare professionals to report AEs
via channels such as email
correspondence, company websites,
and physician hotlines.
80% of internauts are specifically looking for health
information, and nearly 50% are searching for information
about a specific doctor or health professional8
42% of individuals viewing
health information on social
media look at health related
consumer reviews9

34% of consumers say

However, the evolution of social media
information on social
platforms and forums as channels for
media affects their
discussing opinions and exchanging
consumption of certain
experiences, has transformed
medications10
brand-consumer relationships in the
pharmaceutical industry.
Online channels enable access to information and care, allowing patients to
choose where, how, and by whom they would like to be treated. As a result,
consumers today are actively seeking and sharing information to shape
health-related decisions, rather than passively accepting opinions of healthcare
professionals and pharmaceutical companies.

8. NBC News, More People Search for Health Online, 16 Jul 2019
www.digimind.com 9. PWC, Social media "likes" healthcare: From marketing to social business, 7 Jul 2017 17
10. We Go Health, Pharma Social Media Best Practices: Reaching Out Within Regulatory Restrictions, 7 May 2018
It’s Time to Step Up on Social

It is important for brands to adopt a more proactive and transparent approach to social media. Connecting customers with
accurate, digestible information about medicines and treatments is vital to preserving a brand’s trust and reputation among
consumers.

According to Ogilvy Health’s Social Check-Up 201811, pharmaceutical companies are reaching social maturity. Posting strategically
to maximize follower acquisitions and engagement across all four major social channels (Facebook, Twitter, Instagram, YouTube)
was a move employed by many top pharmaceutical companies in 2017.

Unlocking the Benefits of Social Listening

Developing and releasing a new drug is a complex process that can span years, even decades. To ensure your drug’s success and
maximize returns on your research and investment, it is crucial to detect and prevent ADRs from developing into a crisis.

Social media discussions are rife with conversations and honest insights on how consumers’ lifestyles are impacted by your drugs.
Monitoring posts and discussions on social networks and forums can lead pharmaceutical companies to discover new safety
information related to the use of medicinal products. Such information can be used to supplement data obtained from other
channels, including clinical trials and medical surveys.

For example, analysis of 100,000 public Twitter posts12 discussing glucocorticoid therapy from 2012 - 2015 revealed frequent mentions
of insomnia and weight gain as side effects. This trend corroborated with a separate survey1³ carried out on members of an online
health community.

11. Ogilvy Health, The Social Check-Up 2018: Pharma in the Social Space, 16 Mar 2018
12. Nature, Frequent Discussion of Insomnia and Weight Gain with Glucocorticoid Therapy: An Analysis of Twitter Posts, 2019
www.digimind.com 13. US National Library of Medicine, Patient Perceptions of Glucocorticoid Side Effects: A Cross-Sectional Survey of Users in An Online Health Community, 2016 18
 Deploying Digital Networks,
Social Media Intelligence, and
Competitive Intelligence for
Pharmacovigilance

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 Social media activities for PV can be classified under three broad categories14:

Listening Broadcasting Engaging

(Safety Data (Risk (Follow up on
Reporting) Communication) ADRs & AEs)

While each aspect is governed by different complexities and regulations, the aim of using social media for PV should be to:
● Enhance patient safety by disseminating accurate and concise information in a timely manner
● Ensure efficiency and accountability of PV activities

Here are some steps pharmaceutical companies can take to elevate their social media engagement and monitoring strategies for PV:
● Automate information dissemination and engagement via chatbots
● Match insights gathered to the drug lifecycle
● Monitor hotspots on social media

www.digimind.com 14. Sciformix, The Impact and Use of Social Media in Pharmacovigilance 20
Automate Information Dissemination and Engagement via
Chatbots

Chatbots have the potential to save companies USD $8 billion15 in organizational costs
annually. With popular platforms like Facebook Messenger supporting chatbots,
implementation is crucial and a strategic approach for pharmaceutical companies.

Furthermore, with new developments in artificial intelligence, machine learning,

and natural language processing, chatbot technology can not only provide
customer support, but also enhance day to day PV activities through the
following steps:
● Facilitate content discovery while allowing easier navigation of product
information, such as common side effects, by recognizing key topics or
phrases input by customers. Such topics are normally hidden from a
website front page, or hosted on a large and complex database.
● Serve as an alternate channel for patients and healthcare professionals to
report AEs
● Provide anonymity to patients who may be concerned with disease
stigmas, thus encouraging them to come forward with details on their
drug consumption, lifestyle, and health
● Deliver timely industry updates, product information, and disease
education in a personalized and efficient manner

www.digimind.com 15. Juniper Research, Chatbot, A Game Changer For Banking & Healthcare, Saving $8 Billion Annually By 2022, 9 May 2017 21
Monitor Hotspots Online
Collect data on unmet needs, malpractice, and ADRs on social media by setting up your social listening tool to:

Identify who is talking about your product: Segregate online posts by socio-demographic or geographical categories to
detect concerns and complaints from different patient groups and caregivers.

Analyze discussions around your brand or drug: Identify commonalities in consumer complaints. Compare this data against
findings from official data from healthcare professionals, clinical trials, and laboratory tests to determine if you need to
disseminate more educational content, or withdraw your drug from the market.

Extract ADR mentions: Identify the original source and investigate further to identify if it is an AE.

Enhance crisis management: Obtain relevant information in real time, and receive customized alerts on ADRs to increase
reactivity. Pharmaceutical companies can also be alerted to emerging cases around the clock, and minimize the risk of ADR
cases that might otherwise go undetected.

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Match Insights Gathered to the Drug Lifecycle

A listening and analytics tool can help you keep track of and process large volumes of data about multiple products at different
stages in the cycle, enabling you to provide intelligence to various departments in your company to make informed strategic
decisions:

Development (12 - 13 years) Pre-release/ Release Post-release (7 - 8 years)

Critical stages

- Disease and target selection
- Research and development of new
drug
- Preclinical studies
- Clinical trials
- Registration and approval of drug - Lifecycle management
- Drug distribution - Patent extension or expiry
- Label/packaging approval
- Drug pricing and reimbursement

Key insights and trends to monitor

- Identify patients’ unmet needs
- Identify target segmentation
- Analyze consumer perception of
competitors’ products
- Detect potential ADRs of
competitors
- Updates to legislation for future
opportunity and risk detection
- Identify preferred method of
administration
- Monitor scientific breakthroughs in the
pharmaceutical industry
- Monitor updates in local legislation
regarding drug pricing and
reimbursement
- Monitor pricing trends for similar drugs
- Monitor how competitors product is
perceived
- Identify and mitigate potential
cases of pharmacovigilance
- Detect commonalities in
patients’ complaints
- Manage potential crises in cases
of drug misuse or failure
- Insights in medical care and real
life experiences of patient when
using products

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Match Insights Gathered to the Drug Lifecycle
Depending on which stage in the drug lifecycle (development, pre release/release, post release) you are at, you can use these
insights to also:
Provide R&D teams with the
latest industry developments,
discoveries and
breakthroughs in treatments,
diseases, and ADRs
Define a communications
strategy to convey
information about a product
and its side effects to
healthcare professionals,
caregivers, and patients
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Improve your brand
messaging and product
positioning
Pre-empt legal and strategy
departments about any
potential risks, challenges,
and opportunities relating to
their products, especially
blockbuster drugs
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Gather and Share Data

PV is a fundamental aspect of pharmaceutical operations that impacts multiple departments, from research and development to
marketing and legal. To enable teams to make future improvements for drug safety:

Monitor, process and analyze Actively share up to date findings

relevant data and insights. Develop a
hive of collective intelligence within
your organization by allowing
experts to add insider knowledge to
topics.
and news through automated,
Use customized dashboards to
customized reports and newsletters
visualize PV data, including
to demolish knowledge silos. Send
risk-mapping, in real time
only relevant information to prevent
information overload

Considerations for a Regulated Industry

Pharmaceutical companies must be vigilant in verifying safety data obtained via social media, which is often unstructured and
ungoverned. This may prove challenging for those that are used to traditional, structured modes of communication via healthcare
professionals. Furthermore, companies must take additional steps to verify and follow up on AEs reported by patients, who may not
have confirmed data with healthcare professionals, or may be unknowingly spreading fake news.

Therefore, the potential of social media as an added channel for monitoring ADRs should be matched with internal regulations and
investigations to ensure quality and accuracy of data.

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 Summary

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Summary
The Internet and social networks have changed the way consumers express and connect directly with brands. However, consumers
often post online anonymously and without the guidance of healthcare professionals, making it harder for PV departments to verify
claims.

Therefore, while online data (from sources such as but not limited to social media, forums, and news sites) can provide consumer
insights, it should not replace traditional channels for PV. Rather, it should be combined with primary sources such as journals,
claims reported through official channels, and used as secondary data for monitoring trends in consumer usage and claims.

Monitoring tools can help centralize data collection and analysis, as well as disseminate critical updates through automated
reports and newsletters. When managing different groups of interest, having access to real-time information about PV can make a
difference for your drug monitoring projects.

If used appropriately, the Internet and social media can help companies elevate PV practices by:

Functioning as an
Facilitating safety analysis
additional data source on
reports through direct
ADRs and treatment
consumer engagement
impact

Filling potential gaps in Indicating potential safety

identifying, monitoring, issues for further
and reporting AE data investigation

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 Determine Where
Intelligence Tools Fit
Within Your PV Strategy
The function of Intelligence tools is to
gather, process, analyze, and share
industry intelligence with relevant
departments to support executives and
managers with making the right
strategic decisions. For example, by
monitoring patient outlook and
apprehension for a rival drug, you are
able to develop an effective PV strategy
that can be applied to the value for
your own drug product.
Creating a successful intelligence
project involves collecting the right
information across an extended period
of time. The data you collect will enable
you to spot visible patterns and trends,
from which you will create and deliver
actionable insights to the key decision
makers in your organization.
www.digimind.com
Deploy Intelligence at Filter and Use Mentions
Relevant Stages of Your Efficiently
Drug Lifecycle
With vast amounts of consumer
Use intelligence gathered to support
conversations obtainable through an
PV both in pre and post launch phases.
online listening tool, it’s easy to be
For example, monitoring consumer
overwhelmed. Avoid data overload and
complaints about similar products by
maximize relevant insights by using
competitors is useful for helping
customized filters and alerts to source
companies develop superior drugs. You
mentions specifically related to your PV
can also use it for early detection and
needs.
management of ADRs, or to monitor
industry developments and legislations.
Being proactive in sharing data
gathered can go a long way in syncing
efforts to maintain drug safety.
28
Our resources
On managing KPIs to optimize your social media and digital marketing strategies:

Building Effective Social Media 20 KPIs for Your Social Media ROI
Reports for Your Boss Download here
Download here

On best practices and key trends for the industry on social media:

ASUS: Accelerating Product

Development
Download here

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Authors & Resources
Kevin Tran
Marketing (Pharmaceuticals)
Kevin is pursuing his masters in biotechnology and pharmaceutical management. A pharma enthusiast, he has 3
years of experience in quality assurance and regulatory affairs within pharma and biotech industry. Work aside, he
enjoys traveling and visiting art museums.

Melissa Chue
Content Specialist APAC
Melissa is a digital advocate who loves discovering the latest digital and social media trends. When she is not
telling stories about data, she can be found delving into her favourite sub-forums on Reddit.

Sophia Guan
Marketing Manager APAC
With a background in marketing and psychology, Sophia loves the challenge of understanding consumer
behaviour through observations and data. After hours, you’ll find her creating LED or fire inspired art, or roasting
coffee.

Digimind resources
White papers, webinars, studies, infographics...
Digimind’s marketing and insights department offers you many resources to help you review, execute and
evaluate your marketing strategies. To use our resources to understand the evolution of markets and brands on
the web and social media, head over here: http://digimind.com/resources/

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