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Text Content

 * Solutions
 * Biotech
 * Therapeutic Expertise
 * Insights
 * Participate
 * Sites
 * About
 * Search

 * Newsroom
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 * 中国
 * 日本
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 * Newsroom
 * Academy
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 * 中国 China
 * 日本 Japan
 * Contact Us

 * Solutions
 * Biotech
 * Therapeutic Expertise
 * Insights
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 * About
 * 

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SOLUTIONS

Explore end-to-end solutions throughout development — from portfolio
optimization and regulatory strategy, to Phase I-IV clinical trials, market
access planning, and more.

See solutions

WHAT WE DO

 * Portfolio management and asset valuation
 * Early development and innovation
 * Integrated clinical development
 * Approval and access
 * Value substantiation lifecycle management

HOW WE DO IT

 * Delivery models
 * Operational excellence
 * Medical affairs

 * Portfolio management and asset valuation
   * Building patient insights into assets, profile and claims
   * Portfolio optimization
   * Asset valuation and indication prioritization
   * Early evidence review
   * Model-based drug development
   * Integrated development strategy and planning
 * Early development and innovation
   * Phase I Clinical Trials
   * Proof of Concept Studies: Phase IB-IIA
   * Clinical Trial Patient Engagement Strategy and Enrollment Solutions
   * Patient Inclusion
   * Site Alliance Network and KOL Engagement
   * Protocol Optimization
   * Regulatory Strategy
   * Market Access Strategy and Delivery
   * Biomarker and Genomic Medicine Strategy
   * Clinical Trial Supply & Logistics
   * Medical Communications
 * Integrated clinical development
   * Phase IIB-IV Clinical Trials
   * Real World Evidence
   * Clinical Trial Patient Engagement Strategy and Enrollment Solutions
   * Patient Inclusion
   * Protocol-Driven, Customized Site Solution Strategy
   * Regulatory Strategy, Submissions, Compliance, and Outsourcing
   * Market Access Strategy and Delivery
   * Clinical Development Technology Optimization
   * Clinical Trial Supply & Logistics
   * Medical Communications
   * Drug Safety & Pharmacovigilance
 * Approval and access
   * Real World Evidence
   * Global Regulatory Submissions and Outsourcing
   * Compliance and Risk Management
   * Market Access Strategy and Delivery
   * Medical Communications
   * Drug Safety & Pharmacovigilance
 * Value substantiation lifecycle management
   * Real-World Evidence, Market Access Strategy and Planning
   * Regulatory Compliance
   * Lifecycle Optimization
   * Medical Communications
 * FSP delivery models in clinical trials
   * Gain an advantage through FSP
 * Operational excellence
   * Leveraging AI and digital in clinical development
 * Medical affairs for clinical trials

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BIOTECH

Get the personal, responsive, and committed approach of a small CRO, with all
the benefits of a large CRO, to help you develop life-changing treatments for
patients.

Learn more
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THERAPEUTIC EXPERTISE

Utilize our expertise across therapeutic areas, combining innovative trial
designs, leading clinical and regulatory expertise, global reach, and a passion
for changing patient lives.

See expertise

Therapeutic Expertise

 * Neuroscience
 * General medicine
 * Infectious disease & vaccines
 * Inflammation & immunology
 * Oncology
 * Hematology

Cross-Therapeutic Expertise

 * Cell & gene therapies
 * Pediatrics
 * Rare diseases

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INSIGHTS

Our experts help you stay at the forefront of the industry - and ahead of
change.

See insights

New Medicines, Novel Insights

 * New frontiers in neuroscience
 * Precision oncology
 * Rare disease drug development
 * Cell and gene therapy development
 * Patient-guided drug development

Discussions on Diversity

The Regulatory Navigator


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PARTICIPATE

Thinking about joining a clinical trial? Learn the drug development process,
what it’s like to participate, how to find a trial, and answers to frequently
asked questions.

Learn more

INTERESTED IN PARTICIPATING?

 * Healthy volunteers
 * Patient volunteers
 * Patient advocacy groups

HEAR FROM REAL PATIENTS

 * Patient stories

TRIAL SITES

 * Baltimore
 * Los Angeles
 * London
 * Berlin

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SITES

Want to collaborate with us to offer clinical trials at your site? We would
welcome the opportunity to discuss.

Learn more
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ABOUT

We are one of the largest CROs in the world, speeding life-changing medicine to
market by engaging patients With Heart™. Learn about who we are, what we do, and
what we believe.

About Parexel
 * Leadership team
 * Global reach
 * Our DE&I strategy
 * Our ESG strategy
 * Compliance, tax & privacy
 * Meet us at an event

 * Leadership team
   * Board of Directors
 * Global reach
 * Our DE&I strategy
 * Our ESG strategy
 * Compliance, tax & privacy
   * Compliance & Ethics
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 * Meet us at an event

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What can we help you find today?


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The perspectives and opinions expressed in this material represent those of the
patient advocate only and should not be considered a solicitation, promotion or
advertisement for any services of Parexel, or any drugs or therapies, including
those under development. Participating in clinical trials for investigational
medicines offers patients potential benefits, such as access to cutting-edge
treatments and expert medical care, while contributing to medical research.
However, risks may include side effects, unpredictable outcomes, and time
commitment. Careful assessment of these factors helps patients make informed
decisions. The content of this material, including graphics, images and text, is
provided for informational purposes only and does not constitute medical advice,
diagnosis or treatment. Please consult your healthcare professional for medical
advice. The patient advocate has provided their consent for the use and
distribution of this content.

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Patient Story

 * Cell & Gene Therapy
 * Oncology
 * Rare Diseases
 * Inflammation & Immunology
 * Neurosciences


ONE NIGHT, WHILE WATCHING TV WITH HER HUSBAND, ROBYN FELT A LUMP IN HER NECK.

Disclaimer

She had large B-cell lymphoma — an aggressive cancer diagnosed in 150,000
patients each year globally.


AS A DOCTOR, SHE KNEW THE RISK. SHE GOT A CAT SCAN, LOOKED AT THE IMAGES, AND
HER WORLD STOPPED.

Four years later the lymphoma returned. Robyn’s care team prescribed a further
six cycles of a brutal chemotherapy, followed by an autologous stem cell
transplant (ASCT) and external beam radiation. Robyn’s ASCT treatment was
further complicated by septic shock requiring a stay in intensive care.

Robyn entered remission again, but it was short-lived, with the lymphoma
returning nine months later. Treatment options for Robyn were now bleak and
limited.


ROBYN IMMEDIATELY SOUGHT TREATMENT. WITH HER HUSBAND BY HER SIDE, SHE UNDERWENT
MANY ROUNDS OF CHEMOTHERAPY AND WENT INTO REMISSION.


FEELING DEFEATED, SHE FOUND A CLINICAL TRIAL FOR CAR T-CELL THERAPY, A NEW
TREATMENT THAT REENGINEERS WHITE BLOOD CELLS TO TARGET AND ERADICATE CANCER.


SHE THOUGHT THIS WAS HER LAST CHANCE.


A WEEK AFTER RECEIVING TREATMENT, HER LYMPH NODES SHRUNK. WITHIN THREE MONTHS,
THERE WAS NO EVIDENCE OF THE DISEASE.


TODAY, SHE’S CANCER FREE — AND SHARING HER EXPERIENCES TO HELP US BETTER MEET
THE NEEDS OF PATIENTS LIKE HER IN OUR CELL AND GENE THERAPY TRIALS.


LIVES CAN CHANGE WHEN YOU DESIGN CELL AND GENE THERAPY TRIALS WITH SPEED AND
PRECISION.

 * Utilize the right experts, focused on the right indications
 * Access even hard-to-find patient populations
 * Pinpoint the perfect sites for your trial
 * Satisfy global regulations, to get your treatment to market safely and
   quickly

What we do, we do

Our Experts

Our cell and gene therapy specialists collaborate to help get your innovative
treatments to patients like Robyn faster.

MORE EXPERTS

Steve Winitsky, M.D.

Vice President, Tech...




Stefan Zietze

Executive Director, ...




Hicham El Bariqi

Director, Cell & Gen...




Jingke Yang, M.D., Ph.D.

Global TA Section He...





CHRIS LEARN, PH.D., PMP

Vice President, Cell and Gene Therapy, Center of Excellence



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Our Experts

Chris Learn, Ph.D., PMP

Vice President, Cell and Gene Therapy, Center of Excellence

With 20+ years of trial execution and team management experience, Chris leads
development for our cell and gene therapeutic area. He reinforces our
patient-first focus to help ensure your trials are designed to meet patient
needs.

--------------------------------------------------------------------------------

"Being able to capture and understand the patient’s perspective — not just as a
patient, but as a person — and use their insight to guide my decisions is what
it means to work With Heart™."

Our diverse experiences ensure you get the expertise you need, no matter the
indication.



Our experience with CAGT clinical trial sites around the world allows us to
accelerate study start-ups.

 * North America
 * South America
 * Europe
 * APAC
 * Middle East & Africa



Access to global EMR data enables us to pinpoint the perfect sites for your
trial.



Our cross-functional team overcomes any technical, logistical, and strategic
challenges.



Our highly tailored recruitment and retention strategies drive access to even
hard-to-find patient populations.



What can we do to help you change patient lives?

See CAGT capabilities Visit all therapeutic areas Explore CAGT careers

Discover other patient stories

ONCOLOGY

Sara's only symptom was fatigue. But after some routine tests, she was diagnosed
with breast cancer.

View story

RARE DISEASES

When Austin was 3 years old, his parents realized something was wrong. Multiple
falls, concussions, and a broken arm led to a diagnosis.

View story

I&I

Tina had lost her father to Crohn's disease. Now she faced her own diagnosis —
and it derailed her life.

View story

NEUROSCIENCE

While running a triathlon, Andrea stumbled and realized something was wrong. She
thought it was just an injury. But it was much more.

View story

The perspectives and opinions expressed in this material represent those of the
patient advocate only and should not be considered a solicitation, promotion or
advertisement for any services of Parexel, or any drugs or therapies, including
those under development. Participating in clinical trials for investigational
medicines offers patients potential benefits, such as access to cutting-edge
treatments and expert medical care, while contributing to medical research.
However, risks may include side effects, unpredictable outcomes, and time
commitment. Careful assessment of these factors helps patients make informed
decisions. The content of this material, including graphics, images and text, is
provided for informational purposes only and does not constitute medical advice,
diagnosis or treatment. Please consult your healthcare professional for medical
advice. The patient advocate has provided their consent for the use and
distribution of this content.

Close


WE FOCUS ON PATIENTS, BECAUSE THEY INSPIRE US TO DELIVER BETTER TRIALS, FASTER
THAN EVER. SO WE CAN MAKE A DIFFERENCE FOR MORE PATIENTS LIKE ROBYN.

Disclaimer


WHO WE ARE,


PAREXEL IS PROUDLY AMONG THE WORLD’S LARGEST
CLINICAL RESEARCH ORGANIZATIONS

A dedicated CRO providing the full range of Phase I to IV clinical development
services and leveraging the breadth of our clinical, regulatory and therapeutic
expertise, our team of more than 21,000 global professionals works in
partnership with biopharmaceutical leaders and sites to design and deliver
clinical trials with patients in mind, to make clinical research a care option
for anyone, anywhere.



Contact us

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Durham, NC 27713
+1 919 544 3170

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