1. Delivering real-world evidence
to demonstrate product safety & value
Observational research & patient registries
195 patient
registries
and observational
studies since 2003
>9M
patients
in observational and
quality improvement
programs
since 2004

2. Generate the right data
for real results
Many healthcare stakeholders, including physicians, payers
and regulators, are all seeking real-world outcomes to
determine what works best for different patient subgroups
in different situations. Observational research and patient
registries can deliver this type of evidence to meet your
stakeholders’ needs.
These real-world programs demand different expertise and
capabilities because they pose different design and execution
challenges compared to clinical trials. Not only do we
understand these unique challenges, we’ve created proven
methods to solve them. So you can:
• Demonstrate effectiveness or comparative effectiveness
in various populations
• Support coverage decisions by demonstrating economic
value and quality of life benefits
• Evaluate long-term safety and benefit-risk profiles
• Meet post-marketing commitments
• Generate real-world evidence to support new indications
or label extensions
• Understand natural history of disease and change behavior
• Cultivate thought leadership by developing appropriate
market-specific messages
• Bring reliable real-world evidence to internal and external
stakeholders sooner
• Measure and improve quality of care
Since 2003, we’ve delivered many of the leading programs
for disease outcomes, comparative effectiveness, safety
surveillance and risk management. And we can help design
and manage observational studies and patient registries that
clarify your product’s performance and real-world impact.
With new technologies and partnerships opening up unprecedented
access to patient data, generating evidence that can demonstrate the
effectiveness and safety of your products under real-world conditions
is more important than ever.
195 patient registries
and observational
studies since 2003
>600
observational
research
and late phase
specialists
Outcomes data
systems used in
>100 countries
195
>600
>100

3. Find answers to your research
questions quickly and cost-effectively
through our data analytics and
real-world research resources.
Access collaborative partnerships. Reach patients
through our close relationships with providers and healthcare
organizations, public health departments, quality improvement
groups and government agencies.
• >9M patients in observational and quality improvement
programs since 2004
• Studies for 14 patient associations
• More than 2,500 hospitals and 5 million patients
participating in the American Heart Association’s
Get with the Guidelines®
programs
Mine exclusive databases. Use our comprehensive data
assets to inform prospective studies and conduct retrospective
studies and/or hybrid studies, combining prospective data
collection with periodic updates from sources such as electronic
medical records and pharmacy claims. Our electronic medical
record (EMR) database and the Quintiles COMPASS Distributed
Data Network give you access to more than 61 million
de-identified electronic health records used in trial design since
2004 with links to prescription, lab and administrative data.
The Quintiles EMR database supports hybrid studies,
so you can better understand data at different intervals
with different populations – from the use of over-the-
counter medications to patient-reported outcomes.
Engage patients directly. Customize your own patient
program or connect with one of our own patient communities.
Our Patient Relationship Management system can help you
leverage patient-reported data, EMRs, genomic/laboratory
samples and data from digital health devices.
With our proprietary patient communities, you can reach
millions of profiled, highly responsive patients. For example,
MediGuard.org, the largest of our patient communities and
networks, includes 2.8 million patients in the U.S., U.K.,
France, Germany, Spain and Australia. You can mobilize them
quickly to test inclusion/exclusion criteria, collect feedback on
study design and develop messages to enhance participation.
Get closer to patients
and their data
direct-to-patient studies
in more than 30 countries
since 2008>400

4. Start early for lasting impact
The earlier you incorporate real-world research into the product
lifecycle, the fuller picture you can get of your product’s
performance. Ideally, you can begin prospective observational
research right from the start of development. You get critical
data and insights to support feasibility, protocol development
and stakeholder acceptance. Then we can help transition
evidence from early phase research into post-approval. The
result? A better chance of commercial success.
Connect insights at every step
To achieve better outcomes, you need a comprehensive
approach to creating and running effective observational and
registry programs.
Scientific guidance. From study start-up to conduct, tap
into our scientific affairs team to overcome any obstacles.
Our global scientific affairs team – including epidemiologists,
biostatisticians, pharmacists, health economists and clinicians
– can help facilitate study design, analysis and reporting,
including disseminating information through articles and
presentations to local and global audiences.
Operational excellence. No matter the size of your
study, we’ll help implement the right strategy to fulfill your
research objectives. Our dedicated project teams have
your needs covered:
• Project strategy and management
• Site recruitment and support
• Risk minimization
• Medical monitoring
Data-driven technology. Leverage advanced electronic
data capture systems, including the patented, integrated
technology of Quintiles Infosario®
Outcome, for near-
real-time project and safety metrics and analytic tools.1
You’ll get specialized and innovative tools to improve
efficiency and timelines and increase site satisfaction
and return on investment.
Strategic direction. Make sure your research is designed to
capture the right endpoints and outcomes by understanding
stakeholder needs at a deeper level. Take advantage of the
wide-ranging knowledge of our 13 therapeutically aligned
Centers of Excellence. Or access published health technology
assessment reports from nearly 100 agencies in 32 countries.
This online repository provides detailed insights into payer
decision drivers to help you set the strategy for your products.
1
The Outcome System®
service is covered by one or more of the following patents:
U.S. Patent No(s): 7,353,238.

5. Take an integrated approach to stronger safety
Stakeholders today see safety and effectiveness through
the lens of benefit-risk balance. To meet and exceed their
requirements, our experts can help you develop safety and
risk minimization programs that demonstrate or enhance
appropriate and safe use of drugs, biologics and devices.
Select the right program for you:
• Education and behavior evaluation
• Post-Authorisation Safety Studies (PASS), Post-
Authorisation Efficacy Studies (PAES) and safety registries
• Performance-linked and controlled-access programs
Create patient registries that deliver
Whether your priorities are to meet evolving safety,
coverage or reimbursement requirements or demonstrate
good product stewardship, patient registries can give you
invaluable data on real-world outcomes. In fact, registries can
help you meet multi-stakeholder demands through a single
program. From small registries to mega registries, disease-
focused or product-based, we can guide you from concept
to launch by helping you:
• Establish goals, scientific objectives and feasibility
• Design an effective program
• Develop protocols, study plans and materials
• Recruit and manage sites
• Manage and support data collection, cleaning
and reporting
• Analyze data, interpret results, present and publish
Targeted applications for patient registries
• Product safety and effectiveness
• Rare disease
• Pediatrics
• Pregnancy
• Chronic Illness
• Oncology
• Patient quality improvement
• Medical devices
• Vaccines
• Public-private partnerships

6. Copyright©2014Quintiles.Allrightsreserved.01.0007-1-09.14
Contact us
Toll-free: 1 866 267 4479
U.S. direct: +1 973 850 7571
Non-U.S.: +44 203 564 4649
Website: www.quintiles.com
Email: RWLPR@quintiles.com
Meet the latest
quality standards
Count on our relationships with
regulators and experience in
collaborating on industry best
practices to help make a difference
in your real-world studies.
AHRQ Registries User’s Guide
www.effectivehealthcare.ahrq.gov
Under a federal initiative, the U.S. Agency for Healthcare
Research and Quality (AHRQ) selected Quintiles to create a
collaborative handbook on patient registries. This award led to
the publication of “Registries for Evaluating Patient Outcomes:
A User’s Guide” in May 2007, with revised editions in 2010 and
2014. Visit www.effectivehealthcare.ahrq.gov to learn more,
or contact us to request a copy (now also available in Chinese).
AHRQ Observational Comparative Effectiveness
Research Protocol
www.effectivehealthcare.ahrq.gov
Under contract with AHRQ, Quintiles published “Developing a
Protocol for Observational Comparative Effectiveness Research:
A User’s Guide” in January 2013. This guide, now also available
in Chinese, provides key information and identifies minimal
standards and best practices for designing observational
comparative effectiveness research (CER) studies.
GRACE Principles
www.graceprinciples.org
(Good ReseArch for Comparative Effectiveness)
Selected by the National Pharmaceutical Council (NPC),
Quintiles leads the development of good practice principles
and a validated checklist for evaluating individual observational
studies of comparative effectiveness.
ROPR
(Registry of Patient Registries)
Part of an AHRQ task order, Quintiles leads the effort to create
a central index of registries similar to the clinical trials registry,
ClinicalTrials.gov.
ENCePP®
www.encepp.eu
(European Network of Centres for Pharmacoepidemiology
and Pharmacovigilance)
Quintiles is a research center for ENCePP®
, a project aimed
at strengthening the monitoring of post-market medical
products in Europe.
PROTECT-EU
www.imi-protect.eu
(Pharmacoepidemiological Research on Outcomes
of Therapeutics by a European ConsorTium)
Quintiles is a partner within European Medicines Agency
PROTECT-EU, a multi-national consortium of European
organizations formed to develop innovative methods in
pharmacoepidemiology and pharmacovigilance.
ASTER-D
(Adverse Event Spontaneous Triggered Electronic Reports
for Devices)
Quintiles is participating in the ASTER-D project, a pilot focused
on demonstrating the use of a spontaneous trigger approach
to collecting adverse event data through electronic health
records (EHRs) and/or Incident Reporting Systems (IRS) and
transmitting them electronically to the FDA.
The right approach for the right question®
Satisfying stakeholder demands for real-world evidence
takes a clear and convincing value story. To prepare
your product for a long post-approval life, connect
with Quintiles today.
* Industry Standard Research: 2013 and 2014 CRO Quality Benchmarking Phase IV
Service Providers Reports.
Quintiles named industry leader in real-world and late
phase research, 2013 and 2014*