Baseline Plus: ideally suited for orphan drug post-approval studies

Baseline Plus provided the ideal platform to enable a specialised European Pharma company to run a post approval safety study as a licensing requirement. However, managing data from many sites around the world created a major challenge.

There is a growing number of orphan drugs, generally requiring mandated safety studies. Orphan drug studies tend to be long term and based at multiple sites with a small number of patients. Whilst the audience is smaller, it is more knowledgeable and ready to engage.


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 centres 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 HCPs who were mainly research naive. The ease of use led to a reduced burden to subscribers. Baseline Plus allowed for remote management and monitoring which meant the Sponsor could easily manage the study with fewer members of staff.


Baseline Plus enabled this Sponsor to simplify the process, reach all of its global sites and cut the costs for data management. They were able to improve data quality at source by deploying new edit checks each year to support a light touch data management approach. The education module also maintained physician engagement and provided regular updates on recent developments.

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