A biotechnology company selected PRA Health Sciences’ clinical diagnostic services (CDS) group to conduct a global diagnostic study that involved validating innovative, non-invasive blood sample test results collected from high-risk pregnant women against the gold standard results from amniocentesis or chorionic villus sampling.

To successfully complete the programme, the PRA team had to ensure the study tested only high-quality maternal blood samples. Therefore, the study would need to over-enrol for any damaged samples, which would require additional funds.

The study required PRA to deliver milestones under extremely challenging timelines and operational logistics. For example, the team had to fully lock 90% of the subjects five months earlier than originally planned. This ramped-up schedule required the accelerated implementation of a new patient profile review process and reconciliation across six vendors.