Challenges
The client had developed a strong relationship with an NHS Trust and was conducting a series of oncology clinical trials at multiple hospitals within the Trust.
A combination of increasing clinical workload, diminishing research resource including a lack of availability of study team personnel had resulted in study data entry and query resolution requirements not being met and the problem was progressively worsening.
This was significantly impacting both data quality and the willingness of the study teams to recruit further patients.
Solutions
O4 Research was able to rapidly deploy O4 AccelerateTM and place two full time, custom managed O4 Data Managers on-site to support the site study teams across the hospitals. We made all the necessary arrangements to place our Data Managers on-site, making the on-boarding easy for the study teams and keeping them updated regularly throughout the process.
The support was dedicated to the Sponsors’ studies and was shared across the various study teams as needed.
Impact
The Data Managers were able to quickly bring the data entry up to date at each site and subsequently support the site study teams in maintaining a contemporaneous database. In addition, they were able to support query resolution and the upkeep of study related documentation including the ISF.
A significantly lower query rate reduced the frequency of monitoring visits and made these more effective and efficient. The investment in additional support provided the site teams with the confidence to increase recruitment.