Pharma Business Report Series -BRIC Clinical Trial Report Part 6

This is part 6 in Pharma IQ’s report series from a survey of 573 members from the clinical trials community. For the rest of the instalments of this series, please visit our pharma business resource centre.

The benefits and efficiencies of standardising clinical trial design can be outweighed when trials are conducted in a global environment. At Pharma IQ’s Clinical Trial Supply Conference, Alfredo D’Addio Strategic Planner, Global Investigational Material Supply Chain, Celgene Corporation, said: “A lot of the trials are becoming similar in design, so it is very efficient if there is some sort of standardisation, therefore you are not trying to reinvent the wheel every time. The benefits are you have one set of supplies that can be used globally, some of the challenges with that though are the regulations, you will have different regulation requirements for each country and they change.” With patient information being sent to clinical study sites across the globe, the industry is seeking to address challenges like clinical data security: “Through security enabled IT technology, strong standard operating procedures and promotion of ethics in practice,” said Jani. Other survey respondents identified the main challenge as language and cultural barriers at 21.3%, lack of expertise at 12.8%, patient recruitment and retention at 12.2% and clinical trial problems at 11.5%.

Clinical trial supply management can make or break a clinical trial. Getting the clinical logistics right is crucial to the success of a clinical trial and it is paramount that regulatory requirements are fully understood and processes are in place to ensure seamless supply and distribution of clinical materials, so that clinical trial timelines are not comprised.

You will find the rest of this report in our pharma business resource centre. We also have an online hub of our webinars, whitepapers and articles which are completely free to download and should provide answers to any questions you may have on many subjects across the industry.