Competencies Consulting Services Drug Development
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.
Please contact us and we will schedule a full hour complimentary drug development consultancy.Contact Our Experts!
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.