Baseline Plus – ideally suited for orphan drug and post approval research
This specialty European Sponsor was required to run a safety study on one of its orphan drugs as a licensing requirement. However, the challenge was to manage data from a large number of centers around the world, each with only a small number of patients in a cost effective way and with low resources.
Additionally, the company wanted to build a positive relationship with the physicians and wanted to maintain engagement during the long study period.
Baseline Plus enabled the Sponsor to create a simple and intuitive design to support infrequent system access and data entry. The study was deployed in 55 countries and across 125 HCP’s who were mainly research naive.