Chief Investigator busy with limited time to provide leadership and oversight, concern that this would result in lack of coordination, poor site level engagement, suboptimal data quality, project drift, all of which may also place delivery of key publication timelines in jeopardy.
As this was an IIS, our client inherently needed to be independent of the study, and remain ‘hands off’.
Requirement to include 150 patients.
Our client, recognising O4 Research’s operational excellence across previous studies, requested our support as they were confident that this IIS would also run smoothly and efficiently by deploying O4 Research’s expertise. Our specialist team:
Provided effective project coordination via on and off site support, developed and maintained site wide momentum throughout.
Deployed O4 EngageTM, which ensured customised and focused communication activities across all study stakeholders, secured site engagement and supported patient recruitment & retention.
Developed a bespoke, user-friendly EDC system to support data collation and query resolution.
O4 Research’s involvement resulted in a rapid study start-up and a significantly consolidated enrolment period, thereby realising efficiencies in cost and performance. Consequently the volume and quality of the data set resulted in the scope of the study being expanded as it gained more significance.