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Brief History of CTF
The Kemri-Wellcome programme in Kilifi has a long history of conducting clinical trials in illnesses that bring high disease burden and mortality in the community with which we work. We have a good balance of locally led 'academic' type clinical research and product development / drug registration trials. We have built up considerable experience from phase I through to evaluating real-life effectiveness in phase IV trials.
All trials are conducted to ICH-GCP and we manage them through a central system that shares resources and skills. Our Staff work across different trials where possible, and this gives them better opportunity to learn and allows us to share practices and materials. In addition the continuity this brings makes planning possible which enables us to properly resource all our trials and support the career development of our staff.
The clinical trial laboratory within the Kemri-Wellcome programme has full GCLP accreditation and our unit has been audited by the various regulatory bodies from the US and Europe. We work closely with the unit's research laboratory bringing a wide range of in-house expertise such as microbiology, immunology and pharmacology. The hospital also serves as a well-mapped Demographic Surveillance Site (DSS) where a census is conducted three times a year. This is of great benefit for planning and conducting trials.
To be a global centre of excellence for the conduct of clinical trials.
To ensure that our clinical trials capture high quality data and are conducted to the highest ethical standards. We strive to develop a cadre of skilled African clinical trialists to govern and lead our own research agenda.
CTF team comprises of highly skilled cadre of trialists and team members, which includes: Data team, Internal monitors, coordinators, lab team, pharmacy team, quality team and clinical team. Dr Patricia Njuguna is the acting Head of the Clinical Trials Unit. Below is an attachment that elaborates the organization of CTF unit.