Specialized expertise for pediatric clinical research

Transforming trials for the patients who need them most

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Navigating pediatric trial complexity with proven solutions 

Pediatric clinical trials present distinctive challenges that require specialized approaches—from age-appropriate assessments and consent processes to managing high placebo response rates and complex recruitment dynamics.  

With 190+ pediatric studies across 60+ disease indications, we combine deep clinical expertise with purpose-built technology solutions to help sponsors generate high-quality evidence while prioritizing the unique needs of young participants and their families. 

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How our solutions support pediatric trials 

eClinical technologies are an indispensable component in bringing efficiency and accuracy to today’s clinical trials, but thoughtful application is vital for success. Signant SmartSignals® is a comprehensive eClinical solutions suite addressing key challenges and goals associated with oncology trials, supported by an experienced scientific team, ensuring streamlined processes, generation of high-quality evidence and insights, and optimized study management.

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COA Selection & Implementation

We offer expert guidance and support in the selection, licensing, and translation of clinical outcome assessments for both children and caregivers.  Our electronic platforms enable child-friendly formats, seamless in-trial transitions between age-appropriate patient reported outcomes versions, and caregiver access with transparent attributability. 

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Patient & Family Engagement 

In addition to data collection, our app provides engaging learning content, and helpful features to streamline participation – such as up-to-date visit dates and visit information. Caregivers and patients can access the same material to help manage study participation. Our app also includes TeleVisit capabilities, enabling sponsors to conveniently reduce unnecessary clinic attendance with virtual consultations.    

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Flexible, Easy Consent

Our leading eConsent platform enables both patient assent and legally authorized representative consent, with age-appropriate study information content and remote access capabilities that simplify the consent process for families.

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Specialized Rater Training

With decades of experience training investigators in pediatric measures, we provide custom training programs that standardize data collection while incorporating placebo response mitigation strategies specifically designed for pediatric populations. 

Rating and Review

Central Rating & Review 

Our central rating capabilities include specialized expertise in pediatric assessments, ensuring consistent evaluation across global sites while leveraging clinical experts who understand the nuances of pediatric symptom presentation and development.

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Data Quality Monitoring & Analytics 

Advanced analytics, specifically calibrated for pediatric data patterns, help identify quality issues early. Our monitoring approaches account for the unique variability and compliance challenges inherent in pediatric studies. 

 

Proven pediatric trial experience 

190+
STUDIES

10K+
SITES

80K+
PEDIATRIC PATIENTS

60+
INDICATIONS

Expert leadership in pediatric research

Joan Busner, PhD 
Clinical Vice President, Orphan Diseases and Pediatrics 

Dr. Joan Busner has overseen the scientific, clinical, and strategic direction for Signant's pediatric solutions since 2005. With 20 years of prior experience in medical school faculty positions, university clinical trial unit direction, and biomedical IRB service, she brings unparalleled expertise to pediatric trial design and execution.  

Dr. Busner is currently Affiliate Associate Professor of Psychiatry at Virginia Commonwealth University School of Medicine and leads industry thinking through her publications and active roles in working groups and professional societies. 

Ready to Optimize Your Pediatric Trial? 

Our pediatric specialists understand the unique challenges you face and can help design solutions that prioritize scientific excellence, high quality data, and participant experience.