The growing complexities of the drug development process, toughening drug safety standards, increased regulatory scrutiny, and ongoing patent cliff have placed significant pressure on the pharmaceutical industry. In addition, with the number of blockbuster drugs coming off patent year-on-year, many innovators are increasingly examining how best to pick up the deficit. Emerging markets offer many opportunities for innovators undertaking this strategy, thanks to their spending power, potential for high volumes and offshoring capabilities. Dr Chitra Lele of Sciformix Corporation discusses how getting the design and analysis of the clinical trials right is critical to the success of the development programme.