Paediatrics

Onorach has extensive experience and capabilities in working on paediatric clinical trials. Onorach has valuable experience required for PIP and PUMA (which are regulatory requirements to undertake a paediatric clinical trials). Onorach help CROs understand the process of PIP and avoid the typical delays that can occur. These delays are less to do with PIP regulations but with how companies handle the global demands that these paediatric regulations make both financially and in terms of management.

Onorach have a strong track record in obtaining data for PIP which supports authorisation of a medicine for paediatric use. Onorach have developed strategies which overcome the typical patient recruitment challenges faced by traditional CROs by evaluating country, customs, cultures and healthcare access patterns of the paediatric population.

Onorach’s paediatric clinical trial experience and approach means clients do not face the common difficulties associated with patient enrolment, confusion about PIP and PUMA regulations in Europe and PREA and PIP for USA. Onorach’s knowledge and involvement in the early stages of these guidelines ensures paediatric clinical trials hit their timelines and objectives successfully.

In order to stay at the forefront of regulatory guidance and requirements, Onorach can guide you through:
• Developing a Paediatric Investigation Plan (PIP) or Development Plan.
• Paediatric Use Marketing Authorisation (PUMA), legislation for paediatric medicines.
• Recruitment and enrolment of patients.
• Determining a clinical study design.
• Helping to design a strategy to study the Desorption, Distribution, Metabolism, or Excretion of the Investigational Product in the paediatric population.
• Utilisation of tools and databases to ensure evidence based strategies.