Challenges
Success of this global study was being hindered by protracted site set-up and lack of available site resource across multiple territories.
Prior to receiving NICE recommendation in the UK, the study had been activated for almost a year in a number of non-European and central European countries. Due to slow set-up and recruitment, the study had fallen significantly behind schedule and consequently the overall project was in danger of missing the reporting deadline.
Solutions
Deployment of our O4 AccelerateTM and O4 EngageTM methodologies enabled rapid feasibility, site selection and site activation across all UK sites.
We quickly developed a strong rapport through highly effective communication with the extended study teams. This drove recruitment and positively influenced the realignment of the global study team’s objectives and timelines to ensure successful delivery.
In addition, O4 EngageTM enabled our team to provide the Global Sponsor with clear, concise and demonstrable oversight.
Impact
Despite starting significantly later, O4 Research ensured that the UK sites were among the first sites activated across western Europe and the country recruitment target was achieved six months ahead of schedule. This greatly exceeded the Sponsor’s expectations and led to O4 Research being awarded double the original UK allocation. The 100% increase in UK patient allocation was also successfully achieved.