BACKGROUND: A pivotal phase III study of the RTS,S/AS01 malaria candidate 
vaccine is ongoing in several research centres across Africa. The development 
and establishment of quality systems was a requirement for trial conduct to meet 
international regulatory standards, as well as providing an important capacity 
strengthening opportunity for study centres.
METHODS: Standardized laboratory methods and quality assurance processes were 
implemented at each of the study centres, facilitated by funding partners.
RESULTS: A robust protocol for determination of parasite density based on actual 
blood cell counts was set up in accordance with World Health Organization 
recommendations. Automated equipment including haematology and biochemistry 
analyzers were put in place with standard methods for bedside testing of 
glycaemia, base excess and lactacidaemia. Facilities for X-rays and basic 
microbiology testing were also provided or upgraded alongside health care 
infrastructure in some centres. External quality assurance assessment of all 
major laboratory methods was established and method qualification by each 
laboratory demonstrated. The resulting capacity strengthening has ensured 
laboratory evaluations are conducted locally to the high standards required in 
clinical trials.
CONCLUSION: Major efforts by study centres, together with support from 
collaborating parties, have allowed standardized methods and robust quality 
assurance processes to be put in place for the phase III evaluation of the RTS, 
S/AS01 malaria candidate vaccine. Extensive training programmes, coupled with 
continuous commitment from research centre staff, have been the key elements 
behind the successful implementation of quality processes. It is expected these 
activities will culminate in healthcare benefits for the subjects and 
communities participating in these trials.
TRIAL REGISTRATION: Clinicaltrials.gov NCT00866619.