Prioritizing Care: Innovative Approaches to Pediatric Clinical Trials
Work with our experts in pediatric trial design and analytics – we can help you deliver ethical, effective studies for children’s unique therapeutic needs that advance rare disease treatments.
Tailoring Pediatric Clinical Trials with Precision and Care
Pediatric trials pose unique challenges, from ethical considerations to complex regulations. Cytel’s expertise in biometrics shines in navigating these intricacies, offering robust data management, adaptive designs, and safety oversight tailored to your pediatric needs. Our analytic prowess with tools like Xact helps overcome small sample size hurdles, crucial for rare pediatric diseases. With experience in diverse therapeutic areas, we provide data-driven insights, ensuring your trials are conducted with the utmost care and precision. Collaborating with Cytel means partnering for innovation in pediatric research, resulting in meaningful advancements for children’s health.
Contact UsAdaptive design mastery
Tailored adaptive trial designs that reduce patient exposure, enhance study flexibility, and improve chances of clinical success in pediatrics.
Innovative analytical tools
Utilizing Xact for robust statistical power in small sample pediatric studies to maximize insights and guide your pivotal clinical decisions.
Regulatory navigators
We guide you through pediatric trial regulations, ensuring ethical conduct and streamlined approval processes for children’s medications.
Patient-centric data management
Our dedicated pediatric data management prioritizes children’s safety and privacy, supporting your trials with sensitivity and precision.
Advanced Data Strategies for Pediatric Trials
We offer specialized data management and advanced analytics for pediatric trials. Our safety monitoring committees vigilantly oversee patient wellbeing, while our software, such as Xact, adeptly addresses the challenges of small sample sizes. This comprehensive approach ensures high-quality data that supports your regulatory submissions and the development of pediatric therapies. By meticulously capturing and analyzing every data point, Cytel helps you unlock the potential of new treatments for children, even in the most complex of rare diseases.
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Navigating Pediatrics with Adaptive Trial Design
Cytel’s regulatory support extends beyond compliance; we innovate with adaptive trial designs for your pediatric studies, optimizing timelines and outcomes. Our expertise translates into protocols that respect the delicate nature of pediatric research, ensuring that each study meets rigorous ethical standards and advances through regulatory milestones with greater efficiency and effectiveness. By leveraging our extensive experience, we guide you on a smoother regulatory journey towards successful pediatric drug development.
Learn MoreAdvancing Pediatric Health Technology Assessments
Children and young people technologies are often underrepresented in health assessments. Cytel’s Health Economic Outcomes Research (HEOR) team confronts that challenge and helps you meet it. We specialize in methodologies tailored to pediatric populations, ensuring the unique aspects of child health and disease experiences are accounted for. Our nuanced approach to HEOR facilitates the development of evidence that resonates with stakeholders and meets the stringent criteria of bodies like NICE, driving forward the approval of vital pediatric therapies.
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Pioneering Pediatric Study Advances with Admiralpeds
On January 1, 2024, Cytel proudly joined the Admiral installation, a groundbreaking initiative originally launched by Roche and GSK in 2020. As the first CRO to partner in this consortium, Cytel plays a crucial role in advancing pediatric clinical research through Admiralpeds, a dedicated extension of the ADaM in R Asset Library. Admiralpeds is specifically designed to enhance the development of ADaM datasets for pediatric studies, providing an open-source, modular toolbox that supports the pharmaceutical programming community. Alongside industry leaders (Roche, GSK, Pfizer, J&J, Novartis, Amgen, and BMS), Cytel is driving innovations in pediatric analysis, demonstrating our commitment to improving clinical outcomes for younger populations. This leadership in co-development not only underscores our expertise in biostatistics and data management but also enhances our ability to address unique challenges in pediatric clinical trials.
<50%
Drugs approved for adult use have been labelled for use in children (FDA)
10%
Of pediatric patients participate in trials
200
Pediatric exclusivity granted by regulatory instances
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