Globalisation and the increasing complexity of clinical development present new challenges for the pharmaceutical and biotechnology industries in their efforts to manage clinical trial supply chains, a new study warns.

Tellingly, the benchmarking study conducted by US-based management and technology consultants BearingPoint with AMR Research revealed that only 13% of clinical trial products are shipped and received on time and 90% complete, “showcasing the need for significant improvements in the supply chain process”.

The legal and regulatory requirements associated with the growing trend for clinical trials across different geographical locations will “dramatically” increase the complexity of clinical trials by 2010, the study predicts. “The conundrum,” noted Hussain Mooraj, research director, life sciences at AMR Research, “is how to accelerate the speed of development and drive down supply chain costs at the same time.”

A survey of more than 100 pharmaceutical and biotechnology executives found that over 57% of respondents expected to increase or maintain the number of subjects taking part in their Phase I, II and III studies by 2010. Moreover, 26% anticipated conducting 21 or more Phase I studies by that date – an 18% increase on 2007.

There was also a rise of 30% over 2007 in the number of respondents (69%) planning to conduct at least four adaptive trials in 2007. And the survey pointed to significant growth in global trials, with Africa, the Middle East, Eastern Europe and South America topping the list of destinations for regional expansion.

Significant impact
“Globalisation is having a significant impact on every industry, and the pharmaceutical and biotech space is no exception – this study validates that,” said Ellen Reilly, managing director, life sciences for 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.”

According to BearingPoint, the most pressing clinical trial supply-chain challenge identified in its survey was “getting the right kit at the right time to the right site”.