Accelsiors is among those very few European CROs that truly understands importance and challenges associated with the development, initial approval and ongoing updates of Pediatric Investigational Plans (PIP).
We are among those rare CROs that had opportunity to plan and conduct very early phase complex PK/PD trials and in same time to work on robust phase III registration trials in different pediatric populations.
If you are looking for an expert in the field Accelsiors will guide you through the current regulatory framework and ethical considerations for designing and conducting pediatric trials in the EU. We will help you integrating pediatric development into your global drug development, always bearing in mind the strategic and the regulatory aspects.
We will provide you with expert analysis of how to overcome the challenges from pediatric trial set up through to effective study conduct that meets regulatory expectations and beyond. We will advise you how to prepare and successfully submit of robust PIPs.
We offer the following consultancy services in the field:
- We will design for you Pediatric Studies that conforms to global regulations and standards
- 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 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 to develop a global study, consistent with FDA and EMA expectations
- We will be closely monitoring 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 you the best opportunities provided by the current legislation for developers in 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 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 of all necessary documentation to support the submission and validation of PIP 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 how to overcome the challenge of writing detailed PIPs at an early stage where information may be sparse in order to meet the legislative requirements
- We will help you in development of preclinical packages to generate key information for use in pediatric clinical trials and programs.
- Pediatric Drug Development In Oncology
- We will be helping you in development of preclinical testing strategy for new targeted therapies
- We will be planning and conducting clinical trials in special children populations like growth hormone deficiency, cystic fibrosis, renal impairment , dose selection studies
- We will be designing for you Phase III registration studies that meet regulatory and scientific standards
- We will be helping you to maximize patient recruitment and retention in pediatric trials to ensure successful trial conduct through identifying channels for recruitment to obtain age appropriate patient populations, easing recruitment process by working with patient groups and associations, using different media to target and communicate with target patient populations and their families
- We will be helping you in the preparation and presentation of Waivers and Deferrals
- We will guide you to optimally design of pharmacokinetic studies to ensure informative data alignment with acceptable benefit-risk
- We will help you to determine the right trial size
