Benefit from our proven expertise in pediatrics
Clinical development in pediatrics needs a special knowledge and expertise, it consists of a network of complex and interconnected pathways and processes, regulated by an extensive list of rules and directives set forth by the legislators. We are the right CRO partner to maximize your success in pediatric studies.
Accelsiors is an expert in pediatric clinical trials. Throughout the years, we’ve gathered great knowledge in various aspects of this sensitive patient population and developed valuable therapeutic insight that will make a spectacular difference in the results of your study and maximize the value of your clinical development program.
Accelsiors is among the leader CROs in clinical research on pediatric populations for a wide range of therapeutic areas and indications.
- We have conducted more than 80% of Growth Hormone Deficiency trials globally and among others our pediatric research expertise is especially outstanding with Cystic Fibrosis, Renal Impairment, various type of Cancers, Rare and Infectious diseases.
- We have designed and managed 25 pediatric clinical trials from very early phase to robust Phase III registration trials and gathered great knowledge in various aspects of this sensitive patient population, complex PK/PD modelling, handling complexity and selecting optimal sample points, attracting patients to the studies.
Do you need more professional help?
Feel free to ask Accelsiors’ Pediatric Research experts! Please contact us:
Write Us
Call Us: +36 1 299 0091
Request for Proposal
and we will schedule a meeting around your calendar!
Scientific integrity delivered by dedicated pediatric development team
We provide you a flexible support and tailor made solution because we know that each pediatric trial is unique. We have formed our multidisciplinary team of experts called StrongCore Scientific™ group, consisting of Accelsiors’ regulatory, statistical, medical and translational science experts with strong professional background in pediatric clinical trials, along with our trusted consultant pediatricians, PK/PD modelers, imaging experts and other subject specialists.
By utilizing our experienced and knowledgeable experts we can conduct your study with no approval delays or unexpected costs. Our science driven team is supporting our Sponsors by,
- designing and properly setting-up their pediatric trials with an expert analysis on how to overcome challenges arising from pediatric trial set up,
- navigating the legal complexities associated with the pediatric studies, Pediatric Investigation Plans to EMA and FDA, Fast Track / Breakthrough / Orphan Medicinal Product Designation and many other country-specific applications. Accelsiors will guide you through the maze of regulatory framework around the globe,
- proactive risk/issue mitigation,
- supportive culture with an open, consultative approach in collaboration.
Zero compromise towards safety
While carrying out research in children, all efforts should be made to minimize the risks including all harms, discomforts, indignities, embarrassments, and potential breaches of privacy and confidentiality associated with the research. Hence, they deserve the highest standards for monitoring safety during a drug study. This is a guiding principle for our pediatric research team, which is dedicated to pay special attention to minimizing risk in patient’s safety. Everything we do is compliant with all international guidelines and regulatory requirements in pediatric trials.
Quick patient access – Acceleroute™
Realizing that pediatric patient recruitment can often be challenging and complex, we have developed our very special recruitment method called Acceleroute™ in order to save time and effort in patient recruitment and retention. Through our special feasibility methodology we are able to extract the most optimal portfolio of investigational sites and ensure a timey and cost-effective way of patient recruitment around the world.
Patient engagement
One of the most important success factor and the major obstacle in pediatric patient recruitment has shown to be patients’ parents hesitation to let children participate in the study. We are putting the right efforts in properly communicating every study and its advantages to the Investigators to educate and treat the entire family, which results in higher recruitment rates and less drop-outs.
