Expertise
Pediatric Studies
Illuminating the Road to healthy childhood!
Pediatric patients, whether neonates, children, or adolescents, need access to well-evaluated drugs. Pediatric studies are imperative as the age-specific physiologic changes influence drug pharmacokinetics (PK) and pharmacodynamics (PD). For this reason, dosing and safety are not predictable in children and neonates at different developmental stages, and we cannot extrapolate them from adults and often from other age groups.
Despite worldwide regulatory efforts, there is still a significant need to develop new therapies for pediatric diseases and to establish safety, efficacy, and dosing for products that are used off-label in children.
Empowering Excellence in
Pediatric Clinical Research
Accelsiors is an expert CRO in model-based (pharmacometrics) approaches in pediatric drug development, including identifying the dose regimen for different age groups to inform clinical trial design better.
Accelsiors has conducted pediatric clinical research since 2002. We are experts in planning and conducting pediatric clinical trials of all phases and age groups, from first in humans to phase III registration trials, from neonatal to adolescence.
In addition to conducting pediatric trials, we routinely support our clients in finding answers for all complex problems a pediatric drug developer may face.
We provide our expertise in all significant pediatric drug development challenges
- We design state-of-the-art Pediatric Studies fully compliant with global regulations and standards for any age group, phase, or indication
- We help you understand the national regulations and differences across regulatory authorities to ensure compliance across your target markets
- We conduct successful scientific and regulatory compliance feasibility analyses to develop a global study design consistent with FDA and EMA expectations
- We plan and design clinical trials in orphan pediatric indications
- We support the preparation of scientific advice meetings with major regulatory agencies
- We help you maximize patient recruitment and retention in pediatric trials to ensure successful trial conduct
- We are proficient in Pharmacokinetics and Pharmacodynamics analysis and modeling to elucidate better the optimal dosing regimens, frequency, and routes of administration for different age groups and pediatric conditions
- We assist you in better understanding age-related PK/PD differences underlying treatment response in different age groups
- We provide a gamut of support in analyzing the Safety and Tolerability Profile of your investigational product and answering questions about potential age-related differences in drug toxicity or possible long-term effects
- We support you in the development of safety risks mitigation strategies tailored explicitly for pediatric patients
- We support you in decoding the specific mechanisms underlying the disease or condition in pediatric patients to understand better if there are any unique features or differences in disease progression, manifestation, or response to treatment compared to adults
- We support you in searching and validating specific biomarkers or predictive indicators to help identify the most appropriate study endpoints, identify responders or non-responders to the drug stability of those biomarkers in patient stratification, dose individualization, or treatment monitoring
Unlocking Pediatric Research Potential through Scientific Expertise
We consider many other factors when working on study designs considering the most suitable drug formulations and routes of administration. Other factors like drug palatability, ease of administration, and age-appropriate formulations may significantly impact study procedure adherence and compliance.
High-quality pharmacokinetic (PK) and pharmacodynamic (PD) studies are the cornerstone of any pediatric development program. The results of the PK/PD studies are essential in understanding the dose–concentration–response relationship. Without PK data from appropriate populations to support marketing authorizations, clinicians have little choice but to use medications off-label, which can lead to an increased risk of toxicity or subtherapeutic dosing.
PK/PD models can tell the expected effect size during sample size calculations, reducing the burden of unnecessary research and also helping refine dosing strategies relevant to routine clinical practice.
Accelsiors: Shaping the Future of Pediatric Clinical Research
Pediatric clinical trials are more than just ensuring safe treatments for children. They’re about forging a future of holistic, evidence-backed healthcare for all ages. In this mission, Accelsiors shines brightly.
Why Choose Accelsiors?
- 21+ Years of Leadership: Our journey isn’t just about observing changes in clinical research. We’ve been actively shaping and enhancing the quality of pediatric trials. Our experience speaks of deep-rooted expertise.
- Expertise Across All Ages: We’re adept at handling the unique needs of every pediatric age, from newborns to teens. Every trial is designed with precision, keeping the distinct developmental phases in mind.
- Global Reach, Inclusive Research: Accelsiors operates worldwide. Whether it’s early-phase trials or large-scale Phase III studies, we ensure that diverse population nuances are captured, giving depth to our research.
- Quality improvements with QbD: Accelsiors is a pioneer in integrating Quality by Design (QbD) in clinical research. We’ve redefined risk management, anticipating challenges early to ensure trial integrity. Our commitment to QbD showcases our dedication to excellence, ensuring top-tier quality, efficiency, and reliability.
- Building Bridges Globally: We’re at the heart of global collaborations, bridging public and private sectors to fast-track pediatric drug development. Our partnerships guarantee that children worldwide access the latest in medical advancements.
Our Commitment: Accelsiors doesn’t just run trials; we’re shaping the future of pediatric clinical research.
We offer flexible cooperation models:
Clinical Trial Services
Clinical Research Consulting
Functional Service Provider
