Paediatric Trials

We can advise on all stages and aspects of your paediatric programme. Our development and regulatory expertise will help you navigate the unique complexities of developing medicines for children.

We understand the grounds on which exemptions and waivers may be granted by Regulatory Authorities. Our team can work with you to understand your obligations and guide you through the process of requesting an exemption or waiver covering some or all paediatric populations in a specific condition.

A PSP is a legal requirement for almost all new medicines in the US and is usually needed soon after completing Phase 2. Our experts can develop the PSP on your behalf. We can advise on appropriate study designs, age cohorts, study endpoints and statistical considerations.

We can help you identify and manage a suitable Clinical Research Organisation (CRO) to deliver your paediatric clinical trial(s). Our deep knowledge of the CRO market can improve and speed up your CRO selection and qualification process.

With an approved PIP being required for MAA submission in Europe, it’s never too soon to begin this work. Our team can ensure that the necessary data are obtained through clinical studies to support the authorisation of medicines for paediatric populations.

Our Clinical Operations specialists can oversee all operational aspects of the delivery of the paediatric clinical trial programme, using specialist knowledge to optimise execution. Site feasibility and selection, support for recruitment and oversight of monitoring, data management, pharmacovigilance and quality are all services we can offer.