Overcoming obstacles in pediatric clinical research

Specialised expertise in pediatric clinical research

Pediatric patients have significant unmet needs, especially in the areas of rare diseases and orphan indications. During the past few decades, new European regulations have been implemented to advance the development of medicines and medical devices for pediatric use.

However, navigating the regulatory framework can be complex. In addition, several aspects must be taken into consideration such as ethical implications, age-appropriate study strategies, and the children’s physiological and psychological needs. Pediatric study participants are considered a vulnerable population which requires specialised knowledge regarding informed consent, recruiting, inclusion/exclusion criteria, safety monitoring, subject compliance, and subject retention.

We are a full-service contract research organisation (CRO) with proven expertise to help you succeed in your pediatric clinical research. Our team of experts has decades of experience working with pediatric clinical trials in a range of therapeutic areas such as respiratory and metabolic diseases.

We have teams in different European countries that can help you identify the right study sites and support your study sites to achieve their recruitment goals. We also have access to an extensive network of external experts, which enables us to connect you with the specialists you need – when you need it.