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Clinical Trials Facility
The Clinical Trials Facility (CTF) of the KEMRI-Wellcome Trust Research Programme was set up in 2007 to provide a global standard trial centre within the collaborative programme. Based in Kilifi, our role is to work from the point of setting the research question through to analysis and reporting to help ensure all trials run at the unit meet International quality standard. The core aim of using this facility is to enhance the way trials are organised, as an optimum environment for developing highly skilled African trialists.
We have an in-house monitoring team that is trained and with membership to the Institute of Clinical Research and/or Association of Clinical Research Professionals. These are assigned to monitor specific trials. Monitoring ensures all trials comply with ICH-GCP and are thereby being conducted to high ethical standards whilst collecting high quality data.
Some of our trials are externally sponsored and so also receive external monitoring visits from the sponsors. Others are fully in-house trials and for these our monitors provide full cover.
At the KEMRI-Wellcome Trust facility in Kilifi, clinical trials conducted through the Clinical Trial Facility benefit operationally from the following:
- Support, guidance and scientific input from the point of setting the question and trial design to the final report.
- Project management, financial administration and trial coordination
- Full range of in-house SOPs and SOP writing to adapt to sponsor/protocol requirements.
- Centralized budget, staff and resource management
- Fully integrated clinical trial laboratory and coordination with other KEMRI laboratories and clinical services
- Planning and coordination of community engagement and wider communication planning with the units Social and Behavioral Research Group
- A DSS mapped catchment area for the district hospital
- Full data management and statistical support as needed
- Trial monitoring and quality management, regulatory support and safety reporting.