BIO
Rachel Smith
Therapeutic Area Lead, Rare and Genetic Diseases
Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.
Our team optimizes your portfolio utilizing integrated expert clinical, regulatory, and market access strategies, enabling earlier and more informed risk-reward decisions.
Our multi-disciplinary early phase approach accelerates the path to proof of concept by integrating diverse expertise to optimize study design, generate robust clinical evidence, and reduce gaps between development phases.
We deliver whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance. We design patient-informed protocols that remove participation barriers, accelerate enrollment, and increase the likelihood of successful drug launches.
Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, creating customized pathways to maximize global market reach throughout your product's lifecycle.
We enhance your product's value story through post-approval studies and holistic lifecycle management services that satisfy regulators and payers while building stakeholder trust and maximizing your drug's market impact throughout its entire lifecycle.
ParexelAI leverages our full suite of AI capabilities to deliver with greater speed, quality, and efficiency.
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FSP Integrated Solutions
Our FSP solutions combine talent, expertise, technology, and global scale to help sponsors increase productivity, respond to changing pipeline demands, and bring therapies to patients faster.
Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.
Our team delivers high-quality clinical trials through forward-thinking medical expertise across multiple indications by combining strategic insight with operational excellence to support programs of all sizes.
Our infectious disease and vaccines cro services help treat and prevent life-threatening illnesses. Learn how our team of experts can aid in any complex trial.
Discover our inflammation and immunology CRO services. We bring agile support and a unique MOA-driven model to inflammation and immunology.
Parexel is a leading Oncology CRO with more than 80 ex-agency regulators and nearly 2,500 sites globally. Learn more about our oncology indications.
As a leading neuroscience CRO, we leverage global site relationships, specialized resources, and indication-specific expertise to accelerate breakthroughs in neurological and psychiatric treatments for patients worldwide.
As a top hematology CRO, our integrated teams use advanced analytics and real-world evidence to optimize hematology trial outcomes, ensuring faster, more effective drug development.
Rethinking strategies for rescue treatment in wet AMD and retinal vascular disease clinical trials
Learn more
Our experts help you stay at the forefront of the industry — and ahead of change.

Clinical Trialblazers
Step into the world of biotech leaders and hear the untold stories behind their journeys to bring breakthrough innovations to life.
Honest conversations with the experts shaping what's next
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.
Clinical trials provide patients with access to innovative investigational treatments that advance medical research. Participation requires careful consideration that weighs both the benefits and risks.

Patient Stories
Clinical study participation represents a deeply personal decision with potentially far-reaching impact, as evidenced by these inspiring individual stories that highlight both the life-changing potential for participants and the broader advancement of healthcare for all.
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.
With decades of biopharmaceutical leadership experience and a deep dedication to patients, our executive team drives us forward in delivering better trials, faster.
Find key information on our policies, strategies, pay data, and more.
Explore end-to-end solutions throughout development — from portfolio optimization and regulatory strategy, to Phase I-IV clinical trials, market access planning, and more.
Our team optimizes your portfolio utilizing integrated expert clinical, regulatory, and market access strategies, enabling earlier and more informed risk-reward decisions.
Our multi-disciplinary early phase approach accelerates the path to proof of concept by integrating diverse expertise to optimize study design, generate robust clinical evidence, and reduce gaps between development phases.
We deliver whole-study solutions with integrated strategies that ensure safety, data integrity, and regulatory compliance. We design patient-informed protocols that remove participation barriers, accelerate enrollment, and increase the likelihood of successful drug launches.
Our team of former regulators and HTA professionals provide tailored regulatory, compliance, and market access strategies across specialized therapeutic areas, creating customized pathways to maximize global market reach throughout your product's lifecycle.
We enhance your product's value story through post-approval studies and holistic lifecycle management services that satisfy regulators and payers while building stakeholder trust and maximizing your drug's market impact throughout its entire lifecycle.
ParexelAI leverages our full suite of AI capabilities to deliver with greater speed, quality, and efficiency.
![]()
FSP Integrated Solutions
Our FSP solutions combine talent, expertise, technology, and global scale to help sponsors increase productivity, respond to changing pipeline demands, and bring therapies to patients faster.
Utilize our expertise across therapeutic areas, combining innovative trial designs, leading clinical and regulatory expertise, global reach, and a passion for changing patient lives.
Our team delivers high-quality clinical trials through forward-thinking medical expertise across multiple indications by combining strategic insight with operational excellence to support programs of all sizes.
Our infectious disease and vaccines cro services help treat and prevent life-threatening illnesses. Learn how our team of experts can aid in any complex trial.
Discover our inflammation and immunology CRO services. We bring agile support and a unique MOA-driven model to inflammation and immunology.
Parexel is a leading Oncology CRO with more than 80 ex-agency regulators and nearly 2,500 sites globally. Learn more about our oncology indications.
As a leading neuroscience CRO, we leverage global site relationships, specialized resources, and indication-specific expertise to accelerate breakthroughs in neurological and psychiatric treatments for patients worldwide.
As a top hematology CRO, our integrated teams use advanced analytics and real-world evidence to optimize hematology trial outcomes, ensuring faster, more effective drug development.
Rethinking strategies for rescue treatment in wet AMD and retinal vascular disease clinical trials
Learn more
Our experts help you stay at the forefront of the industry — and ahead of change.

Clinical Trialblazers
Step into the world of biotech leaders and hear the untold stories behind their journeys to bring breakthrough innovations to life.
Honest conversations with the experts shaping what's next
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.
Clinical trials provide patients with access to innovative investigational treatments that advance medical research. Participation requires careful consideration that weighs both the benefits and risks.

Patient Stories
Clinical study participation represents a deeply personal decision with potentially far-reaching impact, as evidenced by these inspiring individual stories that highlight both the life-changing potential for participants and the broader advancement of healthcare for all.
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.
With decades of biopharmaceutical leadership experience and a deep dedication to patients, our executive team drives us forward in delivering better trials, faster.
Find key information on our policies, strategies, pay data, and more.
Rachel brings more than a decade of experience in every development phase of rare disease and cell and gene therapy (CGT) clinical trials to her work with Parexel’s rare disease clients. Previously, she served as Vice President of Clinical Operations, Portfolio Director of Rare Disease, and Global Head of the Cell & Gene Center of Excellence at Veristat LLC. She led programs in ADA-SCID, Canavan disease, congenital adrenal hyperplasia, Fabry disease, Gaucher disease, metachromatic leukodystrophy, and Wiskott-Aldrich Syndrome. Rachel has expertise in clinical development strategy, novel and adaptive trial design, decentralized trials, and other creative solutions for rare disease products with a non-classical route to market.
EXCLUSIVE
CTB Blog
Shaping a competitive, patient-centered future for Europe: Insights from the EURORDIS Round Table of Companies
Webinar
FDA Rare Disease Innovation Hub: Enhancing Collaboration and Speed?
Blog
How sponsors can make it easier for rare disease patients and families to participate in trials
Video
Regulatory strategies for EU orphan drug development: Roundtable
Article
How to generate better patient-reported outcomes data
Article
Patient centricity is a broken promise. How can we fix it?
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Report
New Medicines, Novel Insights: Advancing rare disease drug development
EXCLUSIVE
CTB Blog
Shaping a competitive, patient-centered future for Europe: Insights from the EURORDIS Round Table of Companies
Webinar
FDA Rare Disease Innovation Hub: Enhancing Collaboration and Speed?
Blog
How sponsors can make it easier for rare disease patients and families to participate in trials
Video
Regulatory strategies for EU orphan drug development: Roundtable
Article
How to generate better patient-reported outcomes data
Article
Patient centricity is a broken promise. How can we fix it?
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Report
New Medicines, Novel Insights: Advancing rare disease drug development
Learn More