Home > why-veristat company/about approach company/leadership-team corporate-responsibility news global-reach-locations careers careers/open-positions veristat-culture-our-core-values careers/explore-benefits careers/life-at-veristat because-we-care why-veristat therapeutic-expertise Therapeutic areas > therapeutic-expertise/oncology therapeutic-expertise/neurology endocrine-metabolic-disease therapeutic-expertise/immunology-and-inflammation therapeutic-expertise/infectious-disease therapeutic-expertise/covid-19 therapeutic-expertise/cardiology therapeutic-expertise/other solutions full-service-cro-biologics cro-cell-gene therapeutic-expertise/vaccines therapeutic-expertise/rare-diseases therapeutic-expertise/pediatric-clinical-trials decentralizedclinicaltrials clinical-trial-rescue-programs services/full-service-solutions clinical-trial-planning clinical-trial-conduct regulatory-submission solutions/natural-history-studies services services/strategic-consulting adaptive-designs services/introduction-statistical-power services/regulatory-affairs-overview services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design services/regulatory-affairs/regulatory-approvals services/chemistry-manufacturing-controls-cmc services/regulatory-affairs/regulatory-agency-meeting-support services/regulatory-affairs/regulatory-publishing regulatory-medical-device-ivd services/clinical-operations services/clinical-operations/project-management services/clinical-operations/monitoring patient-recruitment-for-clinical-trials patient-retention-and-site-engagement medical-affairs-overview services/medical-affairs/safety-pharmacovigilance services/medical-affairs/data-monitoring-committees services/medical-affairs/medical-monitoring-for-clinical-trials services/regulatory-affairs/medical-writing services/biometrics services/biometrics/data-management services/biometrics/biostatistics services/medical-affairs/data-monitoring-committees services/biometrics/statistical-programming services/biometrics/standards-implementation pharmacovigilance services/strategic-resourcing library blog latest-newsletter contact-us rfp pediatric-clinical-trials Pediatric

Therapeutic Areas

Pediatric Clinical Trials and Regulatory Expertise

Partner with the experts in pediatric clinical development success

Advancing therapies intended to treat pediatric patient populations is highly challenging, and complex.  There are numerous con-founding challenges for treating children, including that many are rare or ultra/rare diseases, many are genetic diseases, and many can be life-threatening.  With this, trial design and conduct come with heightened scrutiny for regulatory, ethical, and safety standards for children as patients.   Finding and treating an adequate patient population requires a highly tailored approach to feasibility, patient recruitment, and site management strategies combined with the use of decentralized or virtual solutions.    

Developing a therapy, biologic, or vaccine for use in children?

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Pediatric Experience In the Past 5 Years 

+0

Pediatric Clinical Trials & Consulting Projects

0%

for rare/ultra-rare diseases​

0%

for biologics

0%

are full-service pediatric clinical trials​

Clinical Trial Support for Pediatric Trials

Home > why-veristat company/about approach company/leadership-team corporate-responsibility news global-reach-locations careers careers/open-positions veristat-culture-our-core-values careers/explore-benefits careers/life-at-veristat because-we-care why-veristat therapeutic-expertise Therapeutic areas > therapeutic-expertise/oncology therapeutic-expertise/neurology endocrine-metabolic-disease therapeutic-expertise/immunology-and-inflammation therapeutic-expertise/infectious-disease therapeutic-expertise/covid-19 therapeutic-expertise/cardiology therapeutic-expertise/other solutions full-service-cro-biologics cro-cell-gene therapeutic-expertise/vaccines therapeutic-expertise/rare-diseases therapeutic-expertise/pediatric-clinical-trials decentralizedclinicaltrials clinical-trial-rescue-programs services/full-service-solutions clinical-trial-planning clinical-trial-conduct regulatory-submission solutions/natural-history-studies services services/strategic-consulting adaptive-designs services/introduction-statistical-power services/regulatory-affairs-overview services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design services/regulatory-affairs/regulatory-approvals services/chemistry-manufacturing-controls-cmc services/regulatory-affairs/regulatory-agency-meeting-support services/regulatory-affairs/regulatory-publishing regulatory-medical-device-ivd services/clinical-operations services/clinical-operations/project-management services/clinical-operations/monitoring patient-recruitment-for-clinical-trials patient-retention-and-site-engagement medical-affairs-overview services/medical-affairs/safety-pharmacovigilance services/medical-affairs/data-monitoring-committees services/medical-affairs/medical-monitoring-for-clinical-trials services/regulatory-affairs/medical-writing services/biometrics services/biometrics/data-management services/biometrics/biostatistics services/medical-affairs/data-monitoring-committees services/biometrics/statistical-programming services/biometrics/standards-implementation pharmacovigilance services/strategic-resourcing library blog latest-newsletter contact-us rfp pediatric-clinical-trials Pediatric

60%

of global operations team members have experience supporting pediatric clinical development​. 

The need to get it right the first time is even more critical when dealing with diseases that affect children.   Many of these are rare and ultra-rare diseases, with very limited patient populations and no other available treatment options.    

Trust our integrated teams to support your pediatric trial with:  

  • Strategic advice from scientific experts across all disciplines to support the planning of your pediatric clinical development program  
  • Operational support to advance your clinical trial to its next milestone by finding and treating the right patients 

Regulatory Consulting Expertise for Pediatric Trials

Home > why-veristat company/about approach company/leadership-team corporate-responsibility news global-reach-locations careers careers/open-positions veristat-culture-our-core-values careers/explore-benefits careers/life-at-veristat because-we-care why-veristat therapeutic-expertise Therapeutic areas > therapeutic-expertise/oncology therapeutic-expertise/neurology endocrine-metabolic-disease therapeutic-expertise/immunology-and-inflammation therapeutic-expertise/infectious-disease therapeutic-expertise/covid-19 therapeutic-expertise/cardiology therapeutic-expertise/other solutions full-service-cro-biologics cro-cell-gene therapeutic-expertise/vaccines therapeutic-expertise/rare-diseases therapeutic-expertise/pediatric-clinical-trials decentralizedclinicaltrials clinical-trial-rescue-programs services/full-service-solutions clinical-trial-planning clinical-trial-conduct regulatory-submission solutions/natural-history-studies services services/strategic-consulting adaptive-designs services/introduction-statistical-power services/regulatory-affairs-overview services/regulatory-affairs/regulatory-consulting-for-program-and-trial-design services/regulatory-affairs/regulatory-approvals services/chemistry-manufacturing-controls-cmc services/regulatory-affairs/regulatory-agency-meeting-support services/regulatory-affairs/regulatory-publishing regulatory-medical-device-ivd services/clinical-operations services/clinical-operations/project-management services/clinical-operations/monitoring patient-recruitment-for-clinical-trials patient-retention-and-site-engagement medical-affairs-overview services/medical-affairs/safety-pharmacovigilance services/medical-affairs/data-monitoring-committees services/medical-affairs/medical-monitoring-for-clinical-trials services/regulatory-affairs/medical-writing services/biometrics services/biometrics/data-management services/biometrics/biostatistics services/medical-affairs/data-monitoring-committees services/biometrics/statistical-programming services/biometrics/standards-implementation pharmacovigilance services/strategic-resourcing library blog latest-newsletter contact-us rfp pediatric-clinical-trials Pediatric

The regulatory roadmap for clinical trials for therapies to treat children requires extra consideration and regulatory oversight.   

Ensure regulatory success with regulatory consulting advice, marketing application support, and regulatory publishing.   

Additionally, if your therapies are intended to treat adult populations, our global regulatory experts can support preparing, writing, and submitting your initial Pediatric Study Plans (iPSPs) and/or Paediatric Investigation Plans (PIPs).   

65%

of global regulatory experts have experience with pediatric therapies   

Global Pediatric Full-Service Phase I/II Clinical Trial Begins on Heels of Successful Natural History Study 

A mid-sized biotech company sought Veristat early in development for help with a Natural History trial. After its successful implementation, the sponsor moved forward with the gene therapy treatment program, which has already treated its first patients.  

Read how Veristat continues to provide full-service support for this Phase 1/2 clinical trial. 

HubDB_Card Image_Flobal Pediatric FSCS

 READ CASE STUDY 

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Scientific Excellence Across Pediatric Clinical Development 

Therapy Areas

Endocrine/Metabolic 
Immunology 
Neurology/Psychiatry 
Oncology/Hematology 
And more… 

happy_people_image11

Rare Diseases

ADA-SCID 
Adrenoleukodystrophy
Duchenne Muscular Dystrophy 
Thalassemia 
And more… 

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Genetic Diseases

Achondroplasia 
Canavan Disease 
Cystic Fibrosis 
X-linked Myotubular Myopathy 
And more… 

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Complex Therapy Types

Biologics 
Cell Therapies 
Gene Therapies 
Vaccines 
And more… 

cellandgene_splicing
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Speak with experts who can help design and run your next pediatric clinical development studies. 

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