The benefits gained from the application of data harmonisation technology, as part of an overall local lab management package in studies where local laboratories have to be used, are best summarised as the ability to provide clients with a ‘central laboratory’ level of service in any study situation.
Components of this service include:-
- A defined and practicable local lab management process in line with regulatory guidelines for Good Clinical Practice, fully documented and audit worthy.
- An effective ‘central’ laboratory level of service, regardless of the number of sites involved, with centralized lab reports and the provision of typical supporting study information to project managers and CRAs.
- A real-time system with respect to resolving data management queries and the removal of time delays by delivering a uniform set of formatted electronic lab data on time and as required.
- Relieving CRAs of the responsibility for local laboratory issue management.
- Reduction in overall study budget costs and increased cost control.