Evolving quality oversight to limit sponsor burden
Case study
Creation of data management asset lead role to represent the sponsor
Overview
ICON was approached by a sponsor to assist in the quality oversight of several projects to ensure consistent adherence to ICON and the sponsor’s standards. The sponsor required ICON’s high-level expertise and proactive solutions when developing new processes and adjusting current ones to meet the need of the sponsor.
Challenges
ICON needed to add a data management asset lead (DMAL) role to provide oversight to a series of studies for each indication/asset where the sponsor did not have the bandwidth to be involved in detailed reviews of documentation. The DMAL was to ensure adherence to ICON’s and the sponsor’s standards, agree on processes, and act as sponsor data management oversight representative.
After the sponsor delegated their oversight responsibilities, ICON had the task of creating and implementing a solution for the lack of a sponsor counterpart. ICON was also required to establish the roles within the team following some confusion amongst the project team regarding the individual responsibilities of the DMAL and lead data manager (LDM).
Solutions
ICON created the DMAL role to provide the appropriate oversight for the sponsor on each project and asset. ICON completed a standard of operating procedure (SOP) deviation without allowing the process to reduce the success of the portfolio.
ICON documented the expectations of each role, retrained staff and provided enhanced therapeutic training to provide an appropriate level of oversight allotment for the team. As the role evolved and sponsor requirements adjusted, ICON developed a ‘lessons learned’ tracker to ensure consistent oversight practices across the portfolio, the growth of which was aligned with the resources.
Outcomes
The implementation of the DMAL role narrowed the gap between traditional CRO and sponsor, which created a partnership with more productive conversations and improved ownership of tasks. The sponsor was satisfied with the finer degree of oversight allowed by having a representative deep-seated in the internal project teams with an in-depth knowledge of ICON’s processes.