Pediatrics
Run your pediatric trials with care and expertise.
Our dedicated team of pediatric experts brings a patient- and family-centered approach to protocol development and study conduct to improve participation, accommodate patients’ needs, and successfully support your trials from start to finish. We’ll identify the best sites, maximize patient recruitment and retention, and handle all technical and logistical challenges to ensure your treatment reaches the children who need it.
Our team includes 20+ pediatricians and physicians with pediatric experience around the world, across a variety of therapeutic areas. This allows us to facilitate M.D.-to-M.D. support and discussion, no matter the therapeutic indication or location of the study. Our Chief Patient Officer, patient insight and rare disease experts also have significant experience in pediatrics, ensuring that our efforts are fueled by patient insights and that any pediatric disease, no matter how rare, is fully supported.
At Parexel we have over 20 pediatricians and pediatric subspecialists covering a variety of therapeutic areas and indications. In addition, we have pediatric recruitment specialists, people who are involved with our patient engagement and advocacy group. We have a patient advisory council. We have regulatory specialists as well who cover pediatrics and help with the development of pediatric investigational plans and pediatric study plans.
So we have a wide variety of experts who could help clients with developing their clinical study plans for pediatric trials, as well as actually operationalizing these pediatric and pediatric rare disease trials. We are seeing a lot of interest in pediatric rare disease trials, in particular for pediatric metabolic conditions. In addition, we are recently working on opportunities related to neonatal trials as well.
This is something that is becoming interesting to clients to assess how to manage pediatric trials with very young children and infants. Some of the things we have been thinking about are how to really reduce burden for families for clinical trials. We look first at the patients, the patient journey, as well as the family considerations when implementing clinical trials for pediatric and pediatric rare disease patients.
We have a patient advisory group at Parexel as well as a nurse advisory group, and these are individuals who could help with even reviewing protocols in advance to see if there are ways to make these protocols more patient and family friendly, while also preserving some of the endpoints and making sure that we are protecting the endpoint data for these clinical trials.
We also focus a lot on supporting patients and families as they proceed through a clinical trial by ensuring transportation or concierge support, and also providing other things such as meal vouchers that could help patients and families with lengthy visits. Another important area at Parexel is our site alliance network. We do have a network of hospitals that offer pediatric services, and we engage regularly with these hospitals and have contracts in place with them so that these hospitals could potentially provide the first patient in for pediatric and pediatric rare disease trials.
So we have a whole network of pediatric experts who could guide clients with their clinical trials from start to finish.
Our experts in Pediatrics
Shipra Patel, M.D.
Global TA Section Head, Endocrinology
Rachel Smith
Executive Director, Rare Disease, Center of Excellence
Stacy Hurt, M.H.A., M.B.A.
Chief Patient Officer
Mwango Kashoki, M.D., M.P.H.
Senior Vice President, Global Head of Regulatory Strategy
Matthias Kruse
Vice President, Technical - Regulatory Strategy
Advantages
The decisions we make are based on a deep understanding of the nuances of the pediatric population, including ethical considerations and the many operational complexities involved, such as precision dosing, blood draws, and informed consent. We know how to address patient needs, parent concerns, and trial complexities — all to drive better results for your patients and trial.
At least 50% of rare diseases affect children. That’s why our rare disease and pediatric teams have remained closely aligned and linked to our Rare Disease Center of Excellence. With significant practical experience in rare disease trials, we apply our insights to rare pediatric projects and can tap into shared expertise in genomics and precision medicine to meet the unique needs of your trial.
Related insights
Blog
Unpacking NICE’s review of the HST routing criteria: implications for manufacturers
Oct 3, 2024
Podcast
Enabling Successful Sites, Ep3: Taking the complexity out of oncology clinical trials
Jun 28, 2024
Podcast
Enabling Successful Sites, Ep2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training
Jun 28, 2024
Podcast
De-risking Drug Development | Episode 1: How to drive value in pre-clinical development
May 28, 2024
Podcast
Rare endpoints: Delivering on unmet patient needs
May 7, 2024
Blog
Accelerating Delivery and Patient Access to Rare Disease Treatments – Highlights from World Orphan Drug Congress
May 2, 2024
Blog
Adapting the validation process for PROs for rare diseases and other diseases with large unmet need and/or rapid progression
Apr 23, 2024
Blog
How sponsors can make it easier for rare disease patients and families to participate in trials
Feb 13, 2024
Blog
Studying rare cancer patient populations using integrated genomic and real-world data
Aug 30, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Playbook
Insights from the 2022 R&D Innovation Survey
Feb 17, 2023
Blog
Rachel Smith joins Parexel as Executive Director and Head of the Rare Disease, Center of Excellence
Aug 10, 2022
Webinar
China's Market Approval Policy and Medical Insurance Payment System for Rare Disease
Jul 21, 2022
Blog
Parexel names first Patient Ambassador
Jun 17, 2022
Whitepaper
Overview of China's Market Approval Policy Med Insurance Payment System
Apr 7, 2022
Related insights
Blog
Unpacking NICE’s review of the HST routing criteria: implications for manufacturers
Oct 3, 2024
Podcast
Enabling Successful Sites, Ep3: Taking the complexity out of oncology clinical trials
Jun 28, 2024
Podcast
Enabling Successful Sites, Ep2: Empowering Sites to be More Inclusive Through Cultural Sensitivity Training
Jun 28, 2024
Podcast
De-risking Drug Development | Episode 1: How to drive value in pre-clinical development
May 28, 2024
Podcast
Rare endpoints: Delivering on unmet patient needs
May 7, 2024
Blog
Accelerating Delivery and Patient Access to Rare Disease Treatments – Highlights from World Orphan Drug Congress
May 2, 2024
Blog
Adapting the validation process for PROs for rare diseases and other diseases with large unmet need and/or rapid progression
Apr 23, 2024
Blog
How sponsors can make it easier for rare disease patients and families to participate in trials
Feb 13, 2024
Blog
Studying rare cancer patient populations using integrated genomic and real-world data
Aug 30, 2023
Blog
Celebrating 40 Years of Rare Disease Progress: WODC Highlights
Jun 6, 2023
Report
New Medicines, Novel Insights: Advancing rare disease drug development
May 22, 2023
Playbook
Insights from the 2022 R&D Innovation Survey
Feb 17, 2023
Blog
Rachel Smith joins Parexel as Executive Director and Head of the Rare Disease, Center of Excellence
Aug 10, 2022
Webinar
China's Market Approval Policy and Medical Insurance Payment System for Rare Disease
Jul 21, 2022
Blog
Parexel names first Patient Ambassador
Jun 17, 2022
Whitepaper
Overview of China's Market Approval Policy Med Insurance Payment System
Apr 7, 2022