Competencies Consulting Services Drug Development
Pediatric Investigational Plan
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Accelsiors is among the leader CROs in clinical research on pediatric populations for a wide range of therapeutic areas and indications
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.
Do you need a clarification for your drug development dilemmas, or you have just got a question that you would like to clarify?
Please contact us and we will schedule a full hour complimentary drug development consultancy.
Contact Our Experts!
Benefit from our proven expertise and two decades of experience in pediatric drug development
Our exerts are ready to support you in the preparation and submission of your Pediatric Investigation Plan
The EMA requires from applicants to exhibit a compliant Pediatric Investigation Plan (PIP) when applying for marketing approval of drugs that targets indications which are present in children.
PIP aims to justify a development program and ensure that all necessary data are obtained through studies in children, to support the authorization of a medicine intended for pediatric use. PIP has to be approved by the EMA Pediatric Committee (PDCO) or a waiver or deferral has to be granted. There are several conditions when PIP waiver can be granted: if medicines is ineffective or unsafe in part or all of the pediatric population, if medicine is intended to treat disease that only affect adult population or in case medicine does not represent a significant therapeutic benefit over existing treatments and/or not fulfil a therapeutic need for pediatric population.
We will advise you how to prepare and successfully submit robust PIPs and we provide expert analysis on how to overcome challenges arising from pediatric trial set up.
- We design Pediatric Studies according to your needs and following the global regulations and standards. We help you in understanding the national regulations and differences across regulatory authorities to ensure compliance across your target markets, and 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 advise you on how to maximize the scientific, marketing/economic, and commercial benefits of the pediatric regulatory requirements and 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.
Let us accelerate your clinical drug development program!
Our team is ready to answer your questions. Get in touch with our experienced clinical drug development experts!
