Over the last decade both the pharmaceutical and biopharmaceutical companies have entered a period where they have become confronted by a variety of complex issues affecting their operational efficiency and profitability. It has now become generally acknowledged that the current business models have now become both economically unsustainable and operationally unsuited to act quickly enough to produce the types of innovative treatments that will be demanded by global markets.
One of the major issues confronting both the pharmaceutical and biopharmaceutical industries is the requirement to a) reduce the escalating costs and risks associated with drug development and b) reduce clinical trial timelines by improving patient recruitment and improving the efficiency of clinical trial results analysis and reporting. The pharmaceutical and biopharmaceutical industry have recognised the opportunities and advantages that exist by conducting clinical trials in what is referred to as the emerging markets. These markets offer significant advantages to the traditional clinical trial settings i.e. rapid recruitment of treatment naive patients from large patient pool, cost benefits associated with lower labour and service fees, improved transparency and compliance with international regulations, expansion of CROs, improved hospital and facilities infrastructure and huge future commercial value in emerging trial markets.
This report analyses the background to these markets including a review of the relevant legislation and regulations governing the control of clinical trials in the key emerging markets as well as analysing the implications and factors which need to be taken into consideration when conducting clinical trials in these markets.
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