FOCUS ON OUR PEDIATRIC EXPERTISE
Accelsiors integrate pediatric development into your global drug development, following all the strategic and regulatory aspects.
In addition to standard patient population, Accelsiors is an expert in pediatric clinical trials. We truly understand the importance and challenges associated with the development, initial approval and ongoing updates of Pediatric Investigation Plans (PIP).
We are experts in planning and conducting pediatric trials irrespective of whether it is a very early phase, complex PK/PD or a robust Phase III registration trial.
Accelsiors will guide you through the current regulatory framework and ethical considerations for designing and conducting pediatric trials around the globe.
We provide expert analysis on how to overcome challenges arising from pediatric trial set up. Also we offer an effective study conduct that meets regulatory expectations and so on. We will advise you how to prepare and successfully submit robust PIPs. In brief:
- We design Pediatric Studies according to your needs and following the global regulations and standards; We conduct studies in any age group, phase or indication;
- We help you in understanding the national regulations and differences across regulatory authorities to ensure compliance across your target markets;
- We assist in the planning of your timelines from EU and US authority’s perspective when preparing your pediatric plan;
- We conduct successful pre-trial analysis and negotiations for you, in order to develop a global study consistent with FDA and EMA expectations;
- We monitor closely and assess the legislative and regulatory impacts of the EU pediatric clinical trial standards and European drug development practices on your actual development program;
- We identify the best opportunities for you, provided by the current legislation for developers in the EU;
- We plan and design clinical trials in special pediatric populations, such as growth hormone deficiency, cystic fibrosis, renal impairment, etc.;
- We advise you on how to maximize the scientific, marketing/economic, and commercial benefits of the pediatric regulatory requirements;
- We assist you in understanding regulations in order to speed up the development and submission of PIPs;
- We identify for you the key factors crucial to the development of a robust PIP;
- We help you in collating all the necessary documentation to support the submission and validation of PIPs and reduce queries;
- We arrange the meetings with EMA committees and working parties, national agencies and other organizations;
- We explain to you the key points of pediatric regulations to aid understanding and compliance with a PIP;
- We guide you on writing detailed PIPs at an early stage (when information may be very sparse), in order to meet the legislative requirements;
- We prepare together the preclinical packages to generate key information for use in pediatric clinical trials and programs;
- We design for you Phase III registration studies that meet regulatory and scientific standards;
- We help you maximize patient recruitment and retention in pediatric trials, in order to ensure successful trial conduct;
- We assist you in the preparation and presentation of PIP Waivers and Deferrals.
Contact us to learn more about Accelsiors’ Pediatric Expertise and discuss on the ways we could collaborate.