FOCUS ON OUR PEDIATRIC EXPERTISE

We will help you integrate pediatric development into your global drug development, always bearing in mind the strategic and the 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 will provide you with expert analysis on how to overcome challenges arising from pediatric trial set up, but also an effective study conduct that meets regulatory expectations and so on. We will advise you how to prepare and successfully submit robust PIPs.

We offer the following services in the field:

  • We will design Pediatric Studies for you, that conform to global regulations and standards;
  • We will conduct Pediatric Studies for you in any age group, phase or indication;
  • We will help you in understanding the national regulations and differences across regulatory authorities to ensure compliance across your target markets;
  • We will assist in the planning of your timelines from EU and US authority’s perspective when preparing your pediatric plan;
  • We will conduct successful pre-trial analysis and negotiations for you, in order to develop a global study consistent with FDA and EMA expectations;
  • We will be monitoring closely and assessing the legislative and regulatory impacts of the EU pediatric clinical trial standards and European drug development practices on your actual development program;
  • We will identify the best opportunities for you, provided by the current legislation for developers in the EU;
  • We shall advise you how to maximize the scientific, marketing/economic, and commercial benefits of the pediatric regulatory requirements;
  • We will assist you in understanding regulations in order to speed up the development and submission of PIPs;
  • We will identify for you the key factors crucial to the development of a robust PIP;
  • We will help you in collating all the necessary documentation to support the submission and validation of PIPs and reduce queries;
  • We will help you in arranging meetings with EMA committees and working parties, national agencies and other organizations;
  • We will be highlighting to you the key points of pediatric regulation to aid understanding and compliance with a PIP;
  • We will be advising you on how to overcome the challenge of writing detailed PIPs at an early stage (when information may still be very sparse), in order to meet the legislative requirements;
  • We will help you in the development of preclinical packages to generate key information for use in pediatric clinical trials and programs;
  • We will plan and design clinical trials in special pediatric populations, such as growth hormone deficiency, cystic fibrosis, renal impairment, etc.;
  • We will design for you Phase III registration studies that meet regulatory and scientific standards;
  • We will help you maximize patient recruitment and retention in pediatric trials, in order to ensure successful trial conduct;
  • We will help you in the preparation and presentation of PIP Waivers and Deferrals.