Challenges
The Sponsor was planning a Post Marketing Observational Study (PMOS) with a requirement to recruit a large number of patients across a finite number of sites. Site resource limitations were likely to result in a protracted recruitment period delaying reporting of study outputs. Previous efforts by the Sponsor to offset such issues including the provision of direct site funding for additional dedicated Research Nurse and Study co-ordinator support had not proved effective.
Solutions
As part of the study design process, O4 Research agreed to provide fully custom managed Research Co-ordinators (CRCs) who would work exclusively on the Sponsor’s study.
These CRCs worked across specific geographical areas, each covering around a third of the study sites. As members of the respective study teams, the CRCs were able to allocate support to sites as required. This included identifying potential patients, introduction of the study to patients, data entry, query resolution and the upkeep of study documentation and ISF maintenance.
By deploying O4 AccelerateTM we were able to rapidly on-board the CRCs without burdening the study teams unduly whilst ensuring they remained updated throughout.
Impact
The result was strong recruitment from the beginning as sites were more inclined to approach each eligible patient and offer them the opportunity to take part. The CRCs were able to share best practice and increase the profile of the study at sites. The support proved cost effective as the CRC presence helped to significantly reduce the overall recruitment period and by doing so, compress study timelines and reduce the associated study management expenditure.
Subsequently, the CRCs were retained to aid data entry and study documentation activity until end of study.
O4 Research’s involvement also helped to significantly reduce both the query rate and the monitoring time required at the sites.