CROMSOURCE Case Study – Respiratory – Paediatric Asthma Study – Rapid Enrolment and high level of protocol compliance

Introduction

The study was managed by CROMSOURCE on behalf of a mid-sized European pharmaceutical
client. It was one of the critical trials for the paediatric Investigation Plan (PIP).
The study involved 88 sites across all regions of Europe. CROMSOURCE was tasked with recruiting a
total of about 1.000 paediatric patients with partly controlled asthma in a period of 8 months.
The primary efficacy of the study was the change from baseline to the end of treatment in pre-dose
morning FEV1.

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