Due to the legal and regulatory requirements associated with global trials, organisations will particularly face new challenges managing the clinical supply chain and efficiently completing trials on time, according to management and technology consultancy firms BearingPoint and AMR Research, who conducted a joint study on the issue. "Globalisation is having a significant impact on every industry, and the pharmaceutical and biotech space is no exception", said Ellen Reilly, managing director of life sciences at BearingPoint. "As a result, these organisations need to be implementing best practices now to efficiently manage their clinical supply chains to bring new drugs to market faster and in an effective manner, while also remaining compliant with global regulations, otherwise, they will be left in the dust trying to navigate this very dynamic and competitive market". The survey of more than 100 biopharma executives revealed that companies are planning a "significant growth" in global trials, with Africa, the Middle East, Eastern Europe and South America topping the list of regional expansion. In addition, the scope and size of trial is set to widen, with more than 57 per cent of survey respondents anticipating increasing or maintaining the number of subjects participating in their Phase I, II, and III studies by 2010. However, according to Hussain Mooraj, research director of life sciences at AMR Research, the complexity, regulatory demands, and disconnected product supply processes are already resulting in an extended and expensive development process. The survey found that the most significant clinical trial supply chain challenge said to be "getting the right kit at the right time to the right site", with only 13 per cent of clinical trial products shipped and received are on time and 90 per cent of orders are complete. Although the survey showcases the need for significant improvements in the supply chain process, the complexities of clinical trials are only set to grow along with the growth in the number of global trials. "The conundrum is how to accelerate the speed of development and drive down supply chain costs at the same time", said Mooraj. BearingPoint said that in order to attempt to tackle the problem, Pfizer recently contracted it to analyse its clinical supply chain business process of shipping clinical active pharmaceutical ingredient (API) internationally. The firm said that it has since completed the analysis and presented Pfizer with a business process improvement plan to help enable the drug giant to redefine its supply chain approach for moving its clinical API material around the globe. Pfizer implemented the new plan at the beginning of this year and the firm said it soon expects to see improvements in shipment lead times, cost reductions, and compliance enhancements. "We were facing a number of clinical API supply chain challenges such as long lead times and short forecast horizons, but our biggest issue was the inconsistency around ownership of the pre-shipment choreography," said Donald Freeman, continuous improvement lead for Pfizer. "Understanding our challenge, we worked with BearingPoint to help us determine the root cause of the performance variability and develop an efficient and consistent future-state shipping process map", said Freeman, adding that through this, Pfizer was able to "focus on the right changes, which will ultimately lead to a more effective clinical supply chain."