SlideShare a Scribd company logo
READYING
YOUR SCIENCE
FOR THE
REAL WORLD
Drug development today is more than a process. It’s a journey.
At PAREXEL, we are committed to making your journey our mission.
To solving problems before they arise. To making the process smarter
and more efficient. To being a true partner to our clients, in every
sense. For over 30 years we have helped our clients get their new and
innovative drug treatments into the hands that need them most by
simplifying their journey to market. Today that means going above and
beyond—at every step along the way.
YOURJOURNEY
OURMISSION
™
NAVIGATING THE JOURNEY TO
MARKET REQUIRES A SPECIAL
TYPE OF PARTNER.
At PAREXEL we bring together the most talented minds,
operational excellence and technology in ways no one else
can match. The results benefit our clients in three ways:
INTEGRATION
A GLOBAL MIND
Global harmonization allows our teams across
the world to serve you effectively as one.
INNOVATION
DRIVEN TO SOLVE THE COMPLEX
Pervasive innovation and continual optimization
help simplify the journey at every step.
PARTNERSHIP
THE BIGGER JOURNEY
A culture of deep collaboration helps accelerate
development cycles and reduce costs.
6
FROM GLOBAL FOOTPRINT
TO GLOBAL MIND.
While no two journeys are exactly alike, our clients share
similar desires to access diverse patient populations, reduce
study costs and conduct high-quality clinical research
worldwide. Today that requires intelligence that only a fully
integrated global network can provide.
A Global Mind 7
625REGULATORY PROFESSIONALS
on staff
95
Helped develop
200 TOP-SELLING
biopharmaceuticals on the market
of the
% A SINGLESHARED TECHNOLOGY PLATFORM
Strategic Partnerships enable
DEEP COLLABORATION
We are 76 offices across 50 countries and still growing. Our offices are staffed
by experts with local knowledge—experts who are prepared to advise on
everything from the right patients to the right investigators and sites for your
needs. They are also acutely aware of local regulatory requirements, so you
can address any potential challenges early in the process. But what truly sets
us apart is how we enable the teams across our global network to support you
as one. We have invested significantly in global harmonization, which means
we ensure your studies are conducted to the same standards of excellence,
from Boston to Beijing.
8
in
OFFICES COUNTRIES
and growing
1,700
76 50
We currently support over
CLINICAL PROJECTS
20 THERAPEUTIC AREAS
in
We can conduct trials in more than
COUNTRIES
100
We work with all of the top
and all of the top
50
30
LARGE
biopharmaceutical
companies
SMALL 
EMERGING
biopharmaceutical
companies
	 A Global Mind 9
EVERY STEP
OF THE JOURNEY
IS AN OPPORTUNITY
TO WORK SMARTER.
10
Though we are well known for our clinical research services,
our breadth of expertise encompasses the continuum of product
development and commercialization, from early planning
through regulatory and post-approval. We view each step as an
opportunity to work smarter, more efficiently and more effectively.
We don’t fear complexity, we embrace it. This mindset, backed
up by achievement, has also enabled us to do pioneering work in
emerging fields like biosimilars. Work that is paving the way
forward for our clients and the industry.
	 Driven to Solve the Complex 11
FROM PATENT
TO PATIENT.
12
PLANNING
The best-laid plans have contingencies built in.
Clinical trials management is only half of our story. We are equally strong in planning
clinical development. Our consulting offerings cover the entire continuum of product
development and commercialization. We bring upfront strategic thinking to the table,
with an eye on your end objective, considering everything from the pathway you want
to take, to the market, to your regulatory strategy, and even to the fit with payers.
THE CLINICAL PATHWAY
Early Phase
Each clinical trial phase requires increased investment, but the early phases are the
foundation on which everything else builds. PAREXEL specializes in Early Product
Development. We also have dedicated Early Phase facilities in five global centers and
all of the expertise required to create cost-efficient development strategies that help
our clients make better early-stage decisions.
Mid-Late Phases
As the scope of each study increases, so do the challenges. PAREXEL rises to meet them
with the largest integrated patient recruiting capability in the industry, logistics and
technology support that are second to none, and a global network that works seamlessly
together to make sure your global study executions are as smart as your plans.
Peri-Approval
Peri-approval studies are on the rise. Effective studies can assist not only in fulfilling
regulatory requirements and gaining market approval, they can also help maximize
return on investment by bridging drug development and commercialization. PAREXEL
supports clients with systems and strategies specifically developed for Phase IIIb studies
that can ultimately help extend product lifecycle, expand prescribing communities and
increase product exposure.
POST-APPROVAL
A new starting line.
Regulatory approval is not the end of the journey. The marketplace today demands the
demonstration of real-world value before fully adopting a new treatment alternative.
In this environment, late-phase observational research has emerged as a key tool to
monitor safety and demonstrate both comparative and cost effectiveness.
PAREXEL combines deep experience on some of the largest Phase IV studies ever
conducted with integrated technology that streamlines study operations to provide
leading-edge service in this massively complex—and increasingly critical—arena.
	 Driven to Solve the Complex 13
PAREXEL is committed to creating partnerships that deliver
value, drive performance and bring new drugs to market faster.
We continue to develop new models that blend client and service-
provider resources for maximum efficiency. We are also redefining
industry standards for service and what one can expect to gain
from the right partnership. Whatever your needs, PAREXEL is
committed to delivering solutions that make sense and to forming
a productive relationship that works for you.
WORKING SMARTER BY
WORKING TOGETHER.
14
OUR CLIENTS HAVE ACCESS TO
HUNDREDS OF MDs IN OUR GLOBAL
NETWORK WHO SPECIALIZE
IN THE TOP THERAPEUTIC AREAS.
PAREXEL RECEIVES
SOME OF THE
HIGHEST AND MOST
CONSISTENT RATINGS
IN THE INDUSTRY.*
STRATEGIC PARTNERSHIPS
A shift in the industry.
As the needs of our customers have evolved, so has PAREXEL.
Increasingly, biopharmaceutical companies are moving away
from tactical engagements with us in favor of longer Strategic
Partnerships, which are designed to deliver greater benefits
throughout the development lifecycle. Strategic Partnerships
can help accelerate development cycles while significantly
reducing overall costs. A Strategic Partnership with PAREXEL
is characterized by a deeper sense of partnership and a mutual
investment in the relationship, as well as the inclusion of
longer-term planning, which together help our clients achieve
efficiencies across the board.
Our Strategic Partners are able to:
• Leverage overhead and infrastructure
• Complement internal knowledge with external expertise
• Improve the predictability of their RD efforts
• Rapidly expand global reach
• Increase operational efficiencies
• Streamline the development process
FUNCTIONAL SERVICES
A la carte solutions that complete your picture.
We don’t believe in one-size-fits-all solutions when it comes to
our working relationships. Our Functional Services unit enables
clients of all sizes to take advantage of our world-class support
for specific functions—without committing to a full research
program. In addition to getting just what they need, clients who
leverage this model continue to benefit from our continuous
process improvements and innovations.
PAREXEL BIOPHARM UNIT
A dedicated unit especially for small and emerging
biopharmaceutical companies.
When the stakes are high, the PAREXEL BioPharm Unit makes
sure you are always the priority. We assign a dedicated team,
including a proactive senior management leader who will
identify and mobilize the right resources from across our
organization. We focus on delivering innovative and effective
study execution, based on aligned incentives, so you can be
confident about meeting each critical development milestone.
*Source: Industry Standard Research (ISR)
	 The Bigger Journey 15
16
A NETWORK OF SERVICES.
AN INTEGRATED APPROACH.
Today, the top 15 biopharmaceutical companies use our technology
solutions. The secret to our success, as with all of our services,
lies in our integrated approach. In addition to retaining over
3,000 dedicated technology and informatics professionals, our
technology solution designs are informed by experts from across
our organization, including Clinical Research Services, Access
and Consulting. Experts who have decades of experience, and who
understand what’s really needed at each step of the journey.
The Bigger Journey 17
INTEGRATED CLINICAL
DEVELOPMENT
•	Phase II-III Clinical Trials
•	Phase IIIb/IV Clinical Trials
•	Regulatory Approval,
	 Compliance  Outsourcing
•	Pricing, Reimbursement,
	 Market Access  RWD
•	Clinical Development
	 Technology Optimization
EARLY DEVELOPMENT
 INNOVATION
•	Phase I Clinical Trials
•	Proof of Concept Studies:
	 Phase Ib-IIa
•	Regulatory Strategy, Planning
	  Compliance
•	Commercial Strategy
	  Planning
APPROVAL  ACCESS
•	Observational Studies 
	 Real World Evidence
	  Data Assets
•	Global Regulatory
	 Submissions  Outsourcing
•	Risk Management 
	Pharmacovigilance
•	Market Access
PORTFOLIO MANAGEMENT
 ASSET EVALUATION
•	Portfolio Optimization
•	Asset Valuation
•	Indication Prioritization
	 Related Services
•	Early Evidence Review
•	Model-Based Drug
	Development
•	Integrated Development
	 Strategy  Planning
DISCOVERY EARLY STAGE LATE STAGE POST APPROVAL
LIFECYCLE  PRODUCT
MANAGEMENT
•	Post Authorization Safety
	  Surveillance Studies
•	Regulatory Compliance:
	 Risk Management
•	Lifecycle Maintenance
	  Outsourcing
•	Evidence  License/Market
	Expansion
PORTFOLIO MANAGEMENT  ASSET EVALUATION
INTEGRATED CLINICAL DEVELOPMENT
APPROVAL  ACCESS
LIFECYCLE  PRODUCT MANAGEMENT
EARLY DEVELOPMENT  INNOVATION
18
Our regional leads are always available for a conversation.
WHEREVER YOUR
JOURNEY TAKES YOU,
WE’RE CLOSE BY.
EUROPE
Graham Sanders
Vice President,
Business Development
+44 1895 614 319
graham.sanders@PAREXEL.com
ASIA PACIFIC
Brian Yang
Vice President,
Business Development
+886 2 21769525
brian.yang@PAREXEL.com
UNITED STATES
Frederick LeMoine
Vice President,
Business Development
+1 919 294 5125
frederick.lemoine@PAREXEL.com
LEARN MORE AT PAREXEL.com
	 Contact Us 19
©2016 PAREXEL International Corp. All rights reserved.
Cover  back cover: organic cell (top image), Seattle cityscape (bottom image)
PAREXEL International Corporation | PAREXEL.com
195 West Street, Waltham, MA 02451 | +1 781 487 9900

More Related Content

What's hot

New TTI 31MAI2016 General
New TTI 31MAI2016 GeneralNew TTI 31MAI2016 General
New TTI 31MAI2016 General
Marise Gomes
 
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
Engineers Australia
 
OC Partnership Presentation2016
OC Partnership Presentation2016OC Partnership Presentation2016
OC Partnership Presentation2016
Bill McGuane
 
BLG_AnnualReport2014_63647
BLG_AnnualReport2014_63647BLG_AnnualReport2014_63647
BLG_AnnualReport2014_63647
Michael Dilling
 
Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014
Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014
Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014
az_hbio
 
KRSNAK_IGOR_CV_ENG
KRSNAK_IGOR_CV_ENGKRSNAK_IGOR_CV_ENG
KRSNAK_IGOR_CV_ENG
Igor Krsnak
 
Vishal Meswani-New Resume
Vishal Meswani-New ResumeVishal Meswani-New Resume
Vishal Meswani-New Resume
Vishal Meswani
 
Streamlining Material Management, Development, and Launch
Streamlining Material Management, Development, and LaunchStreamlining Material Management, Development, and Launch
Streamlining Material Management, Development, and Launch
Imperial CRS
 

What's hot (20)

Top stories of the 2nd pharma maintenance2 reliability minds conference 2013
Top stories of the 2nd pharma maintenance2 reliability minds conference 2013Top stories of the 2nd pharma maintenance2 reliability minds conference 2013
Top stories of the 2nd pharma maintenance2 reliability minds conference 2013
 
New TTI 31MAI2016 General
New TTI 31MAI2016 GeneralNew TTI 31MAI2016 General
New TTI 31MAI2016 General
 
Pharma Magazine (Issue - 29)
Pharma Magazine (Issue - 29)Pharma Magazine (Issue - 29)
Pharma Magazine (Issue - 29)
 
Pharma compliance EU 2015
Pharma compliance EU 2015Pharma compliance EU 2015
Pharma compliance EU 2015
 
“A study on customer feedback and upgradation of Haem up vet launched or intr...
“A study on customer feedback and upgradation of Haem up vet launched or intr...“A study on customer feedback and upgradation of Haem up vet launched or intr...
“A study on customer feedback and upgradation of Haem up vet launched or intr...
 
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
ICWES15 - Medical Devices - Partnering for Success. Presented by Prof Karen R...
 
If you’ve always been one of us
If you’ve always been one of usIf you’ve always been one of us
If you’ve always been one of us
 
OC Partnership Presentation2016
OC Partnership Presentation2016OC Partnership Presentation2016
OC Partnership Presentation2016
 
BLG_AnnualReport2014_63647
BLG_AnnualReport2014_63647BLG_AnnualReport2014_63647
BLG_AnnualReport2014_63647
 
SMi Group's 10th annual Pre-filled Syringes Europe 2018 conference & exhibition
SMi Group's 10th annual Pre-filled Syringes Europe 2018 conference & exhibitionSMi Group's 10th annual Pre-filled Syringes Europe 2018 conference & exhibition
SMi Group's 10th annual Pre-filled Syringes Europe 2018 conference & exhibition
 
Brochure
BrochureBrochure
Brochure
 
Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014
Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014
Hbio slide deck sidotti 5.6.9.2014 revised 5.2.2014
 
KRSNAK_IGOR_CV_ENG
KRSNAK_IGOR_CV_ENGKRSNAK_IGOR_CV_ENG
KRSNAK_IGOR_CV_ENG
 
Company Presentation Final June 2008
Company Presentation   Final June 2008Company Presentation   Final June 2008
Company Presentation Final June 2008
 
Capio Nightingale
Capio NightingaleCapio Nightingale
Capio Nightingale
 
Vishal Meswani-New Resume
Vishal Meswani-New ResumeVishal Meswani-New Resume
Vishal Meswani-New Resume
 
Aptuit Consulting Inc
Aptuit Consulting IncAptuit Consulting Inc
Aptuit Consulting Inc
 
Ojas Medicom Solutions
Ojas Medicom SolutionsOjas Medicom Solutions
Ojas Medicom Solutions
 
Streamlining Material Management, Development, and Launch
Streamlining Material Management, Development, and LaunchStreamlining Material Management, Development, and Launch
Streamlining Material Management, Development, and Launch
 
SMi Group's Inaugural Big Data in Pharma conference
SMi Group's Inaugural Big Data in Pharma conferenceSMi Group's Inaugural Big Data in Pharma conference
SMi Group's Inaugural Big Data in Pharma conference
 

Similar to Readying Your Science for the Real World

PAREXEL BioPharm Unit
PAREXEL BioPharm UnitPAREXEL BioPharm Unit
PAREXEL BioPharm Unit
Neil Butera
 
Report : Financial analysis of aanjaneya life care
Report : Financial analysis of aanjaneya life careReport : Financial analysis of aanjaneya life care
Report : Financial analysis of aanjaneya life care
Swapnil Chavan
 
גיל פוגוזליץ- GHP investor presentation (eng) 01-0316
גיל פוגוזליץ- GHP investor presentation (eng) 01-0316גיל פוגוזליץ- GHP investor presentation (eng) 01-0316
גיל פוגוזליץ- GHP investor presentation (eng) 01-0316
ZivBenSira
 

Similar to Readying Your Science for the Real World (20)

PAREXEL BioPharm Unit
PAREXEL BioPharm UnitPAREXEL BioPharm Unit
PAREXEL BioPharm Unit
 
Advance Your Program in China with Fully Integrated Clinical Development Solu...
Advance Your Program in China with Fully Integrated Clinical Development Solu...Advance Your Program in China with Fully Integrated Clinical Development Solu...
Advance Your Program in China with Fully Integrated Clinical Development Solu...
 
EPM Scientific brochure - Europe
EPM Scientific brochure - EuropeEPM Scientific brochure - Europe
EPM Scientific brochure - Europe
 
Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClisOptimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
Optimizing Clinical Trial Operations - Alexander Fetkovsky, SanaClis
 
Report : Financial analysis of aanjaneya life care
Report : Financial analysis of aanjaneya life careReport : Financial analysis of aanjaneya life care
Report : Financial analysis of aanjaneya life care
 
Navicor Capabilities
Navicor Capabilities Navicor Capabilities
Navicor Capabilities
 
The Hub – Solutions Distinctly for Nimble Biotechs Brochure
The Hub – Solutions Distinctly for Nimble Biotechs Brochure The Hub – Solutions Distinctly for Nimble Biotechs Brochure
The Hub – Solutions Distinctly for Nimble Biotechs Brochure
 
Bhavna final
Bhavna finalBhavna final
Bhavna final
 
Drug Development Solutions Distinctly for the Progressive Biopharma Ventures ...
Drug Development Solutions Distinctly for the Progressive Biopharma Ventures ...Drug Development Solutions Distinctly for the Progressive Biopharma Ventures ...
Drug Development Solutions Distinctly for the Progressive Biopharma Ventures ...
 
ttopstart brochure
ttopstart brochurettopstart brochure
ttopstart brochure
 
The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September ...
The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September ...The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September ...
The 10 Most Innovative Pharma and Biotech Solution Providers, 2020 September ...
 
גיל פוגוזליץ- GHP investor presentation (eng) 01-0316
גיל פוגוזליץ- GHP investor presentation (eng) 01-0316גיל פוגוזליץ- GHP investor presentation (eng) 01-0316
גיל פוגוזליץ- GHP investor presentation (eng) 01-0316
 
Generic Pharma 2.0 Consulting - Challenge the Status Quo
Generic Pharma 2.0 Consulting -  Challenge the Status QuoGeneric Pharma 2.0 Consulting -  Challenge the Status Quo
Generic Pharma 2.0 Consulting - Challenge the Status Quo
 
Eyeforpharma 2016 barcelona
Eyeforpharma 2016 barcelonaEyeforpharma 2016 barcelona
Eyeforpharma 2016 barcelona
 
The most recommended pharma & life sciences solution providers in 2021
The most recommended pharma & life sciences solution providers in 2021The most recommended pharma & life sciences solution providers in 2021
The most recommended pharma & life sciences solution providers in 2021
 
eBook - Five Secrets Of Smart Ophthalmic EHR Buyers
eBook - Five Secrets Of Smart Ophthalmic EHR BuyerseBook - Five Secrets Of Smart Ophthalmic EHR Buyers
eBook - Five Secrets Of Smart Ophthalmic EHR Buyers
 
TNS Vietnam Healthcare Credential 2013
TNS Vietnam Healthcare Credential 2013TNS Vietnam Healthcare Credential 2013
TNS Vietnam Healthcare Credential 2013
 
6 Secrets of Smart EHR Buyers
6 Secrets of Smart EHR Buyers6 Secrets of Smart EHR Buyers
6 Secrets of Smart EHR Buyers
 
SA_Brochure_2014
SA_Brochure_2014SA_Brochure_2014
SA_Brochure_2014
 
The 10 most inspirational business leaders to watch in 2021
The 10 most inspirational business leaders to watch in 2021The 10 most inspirational business leaders to watch in 2021
The 10 most inspirational business leaders to watch in 2021
 

Readying Your Science for the Real World

  • 2. Drug development today is more than a process. It’s a journey. At PAREXEL, we are committed to making your journey our mission. To solving problems before they arise. To making the process smarter and more efficient. To being a true partner to our clients, in every sense. For over 30 years we have helped our clients get their new and innovative drug treatments into the hands that need them most by simplifying their journey to market. Today that means going above and beyond—at every step along the way.
  • 4. NAVIGATING THE JOURNEY TO MARKET REQUIRES A SPECIAL TYPE OF PARTNER. At PAREXEL we bring together the most talented minds, operational excellence and technology in ways no one else can match. The results benefit our clients in three ways:
  • 5. INTEGRATION A GLOBAL MIND Global harmonization allows our teams across the world to serve you effectively as one. INNOVATION DRIVEN TO SOLVE THE COMPLEX Pervasive innovation and continual optimization help simplify the journey at every step. PARTNERSHIP THE BIGGER JOURNEY A culture of deep collaboration helps accelerate development cycles and reduce costs.
  • 6. 6 FROM GLOBAL FOOTPRINT TO GLOBAL MIND. While no two journeys are exactly alike, our clients share similar desires to access diverse patient populations, reduce study costs and conduct high-quality clinical research worldwide. Today that requires intelligence that only a fully integrated global network can provide.
  • 8. 625REGULATORY PROFESSIONALS on staff 95 Helped develop 200 TOP-SELLING biopharmaceuticals on the market of the % A SINGLESHARED TECHNOLOGY PLATFORM Strategic Partnerships enable DEEP COLLABORATION We are 76 offices across 50 countries and still growing. Our offices are staffed by experts with local knowledge—experts who are prepared to advise on everything from the right patients to the right investigators and sites for your needs. They are also acutely aware of local regulatory requirements, so you can address any potential challenges early in the process. But what truly sets us apart is how we enable the teams across our global network to support you as one. We have invested significantly in global harmonization, which means we ensure your studies are conducted to the same standards of excellence, from Boston to Beijing. 8
  • 9. in OFFICES COUNTRIES and growing 1,700 76 50 We currently support over CLINICAL PROJECTS 20 THERAPEUTIC AREAS in We can conduct trials in more than COUNTRIES 100 We work with all of the top and all of the top 50 30 LARGE biopharmaceutical companies SMALL EMERGING biopharmaceutical companies A Global Mind 9
  • 10. EVERY STEP OF THE JOURNEY IS AN OPPORTUNITY TO WORK SMARTER. 10
  • 11. Though we are well known for our clinical research services, our breadth of expertise encompasses the continuum of product development and commercialization, from early planning through regulatory and post-approval. We view each step as an opportunity to work smarter, more efficiently and more effectively. We don’t fear complexity, we embrace it. This mindset, backed up by achievement, has also enabled us to do pioneering work in emerging fields like biosimilars. Work that is paving the way forward for our clients and the industry. Driven to Solve the Complex 11
  • 13. PLANNING The best-laid plans have contingencies built in. Clinical trials management is only half of our story. We are equally strong in planning clinical development. Our consulting offerings cover the entire continuum of product development and commercialization. We bring upfront strategic thinking to the table, with an eye on your end objective, considering everything from the pathway you want to take, to the market, to your regulatory strategy, and even to the fit with payers. THE CLINICAL PATHWAY Early Phase Each clinical trial phase requires increased investment, but the early phases are the foundation on which everything else builds. PAREXEL specializes in Early Product Development. We also have dedicated Early Phase facilities in five global centers and all of the expertise required to create cost-efficient development strategies that help our clients make better early-stage decisions. Mid-Late Phases As the scope of each study increases, so do the challenges. PAREXEL rises to meet them with the largest integrated patient recruiting capability in the industry, logistics and technology support that are second to none, and a global network that works seamlessly together to make sure your global study executions are as smart as your plans. Peri-Approval Peri-approval studies are on the rise. Effective studies can assist not only in fulfilling regulatory requirements and gaining market approval, they can also help maximize return on investment by bridging drug development and commercialization. PAREXEL supports clients with systems and strategies specifically developed for Phase IIIb studies that can ultimately help extend product lifecycle, expand prescribing communities and increase product exposure. POST-APPROVAL A new starting line. Regulatory approval is not the end of the journey. The marketplace today demands the demonstration of real-world value before fully adopting a new treatment alternative. In this environment, late-phase observational research has emerged as a key tool to monitor safety and demonstrate both comparative and cost effectiveness. PAREXEL combines deep experience on some of the largest Phase IV studies ever conducted with integrated technology that streamlines study operations to provide leading-edge service in this massively complex—and increasingly critical—arena. Driven to Solve the Complex 13
  • 14. PAREXEL is committed to creating partnerships that deliver value, drive performance and bring new drugs to market faster. We continue to develop new models that blend client and service- provider resources for maximum efficiency. We are also redefining industry standards for service and what one can expect to gain from the right partnership. Whatever your needs, PAREXEL is committed to delivering solutions that make sense and to forming a productive relationship that works for you. WORKING SMARTER BY WORKING TOGETHER. 14
  • 15. OUR CLIENTS HAVE ACCESS TO HUNDREDS OF MDs IN OUR GLOBAL NETWORK WHO SPECIALIZE IN THE TOP THERAPEUTIC AREAS. PAREXEL RECEIVES SOME OF THE HIGHEST AND MOST CONSISTENT RATINGS IN THE INDUSTRY.* STRATEGIC PARTNERSHIPS A shift in the industry. As the needs of our customers have evolved, so has PAREXEL. Increasingly, biopharmaceutical companies are moving away from tactical engagements with us in favor of longer Strategic Partnerships, which are designed to deliver greater benefits throughout the development lifecycle. Strategic Partnerships can help accelerate development cycles while significantly reducing overall costs. A Strategic Partnership with PAREXEL is characterized by a deeper sense of partnership and a mutual investment in the relationship, as well as the inclusion of longer-term planning, which together help our clients achieve efficiencies across the board. Our Strategic Partners are able to: • Leverage overhead and infrastructure • Complement internal knowledge with external expertise • Improve the predictability of their RD efforts • Rapidly expand global reach • Increase operational efficiencies • Streamline the development process FUNCTIONAL SERVICES A la carte solutions that complete your picture. We don’t believe in one-size-fits-all solutions when it comes to our working relationships. Our Functional Services unit enables clients of all sizes to take advantage of our world-class support for specific functions—without committing to a full research program. In addition to getting just what they need, clients who leverage this model continue to benefit from our continuous process improvements and innovations. PAREXEL BIOPHARM UNIT A dedicated unit especially for small and emerging biopharmaceutical companies. When the stakes are high, the PAREXEL BioPharm Unit makes sure you are always the priority. We assign a dedicated team, including a proactive senior management leader who will identify and mobilize the right resources from across our organization. We focus on delivering innovative and effective study execution, based on aligned incentives, so you can be confident about meeting each critical development milestone. *Source: Industry Standard Research (ISR) The Bigger Journey 15
  • 16. 16 A NETWORK OF SERVICES. AN INTEGRATED APPROACH. Today, the top 15 biopharmaceutical companies use our technology solutions. The secret to our success, as with all of our services, lies in our integrated approach. In addition to retaining over 3,000 dedicated technology and informatics professionals, our technology solution designs are informed by experts from across our organization, including Clinical Research Services, Access and Consulting. Experts who have decades of experience, and who understand what’s really needed at each step of the journey.
  • 17. The Bigger Journey 17 INTEGRATED CLINICAL DEVELOPMENT • Phase II-III Clinical Trials • Phase IIIb/IV Clinical Trials • Regulatory Approval, Compliance Outsourcing • Pricing, Reimbursement, Market Access RWD • Clinical Development Technology Optimization EARLY DEVELOPMENT INNOVATION • Phase I Clinical Trials • Proof of Concept Studies: Phase Ib-IIa • Regulatory Strategy, Planning Compliance • Commercial Strategy Planning APPROVAL ACCESS • Observational Studies Real World Evidence Data Assets • Global Regulatory Submissions Outsourcing • Risk Management Pharmacovigilance • Market Access PORTFOLIO MANAGEMENT ASSET EVALUATION • Portfolio Optimization • Asset Valuation • Indication Prioritization Related Services • Early Evidence Review • Model-Based Drug Development • Integrated Development Strategy Planning DISCOVERY EARLY STAGE LATE STAGE POST APPROVAL LIFECYCLE PRODUCT MANAGEMENT • Post Authorization Safety Surveillance Studies • Regulatory Compliance: Risk Management • Lifecycle Maintenance Outsourcing • Evidence License/Market Expansion PORTFOLIO MANAGEMENT ASSET EVALUATION INTEGRATED CLINICAL DEVELOPMENT APPROVAL ACCESS LIFECYCLE PRODUCT MANAGEMENT EARLY DEVELOPMENT INNOVATION
  • 18. 18
  • 19. Our regional leads are always available for a conversation. WHEREVER YOUR JOURNEY TAKES YOU, WE’RE CLOSE BY. EUROPE Graham Sanders Vice President, Business Development +44 1895 614 319 graham.sanders@PAREXEL.com ASIA PACIFIC Brian Yang Vice President, Business Development +886 2 21769525 brian.yang@PAREXEL.com UNITED STATES Frederick LeMoine Vice President, Business Development +1 919 294 5125 frederick.lemoine@PAREXEL.com LEARN MORE AT PAREXEL.com Contact Us 19
  • 20. ©2016 PAREXEL International Corp. All rights reserved. Cover back cover: organic cell (top image), Seattle cityscape (bottom image) PAREXEL International Corporation | PAREXEL.com 195 West Street, Waltham, MA 02451 | +1 781 487 9900