Pharma Business Report Series -BRIC Clinical Trial Report Part 7


Pharma IQ
10/01/2012

This report has been compiled from a survey of 573 industry professionals who deal with clinical trials as part of their pharma business. Pharma IQ have compiled a pharma business resource centre where you will find the rest of this detailed report as well as many other informative reports and articles.

Mukesh Kumar, President of the Global Alliances of Indian Biomedical Professionals told Pharma IQ: “Logistics is a bigger issue when including emerging countries. Once the logistics are taken care of, it becomes relatively easy to execute…You can’t have too many variables. So either you plan for the number of patients and an out and out amount of drug for the number of sites, but if you do too many variables, it becomes more and more logistically hard to manage those trials.”

“Try to plan in such a way that they can predict much better how much of each of the logistical issues they would need to address when including any of these countries. Once those are addressed, everything else becomes easier,” Kumar added.

For many stakeholders in the clinical trial supply arena supporting the expansion of clinical trials into emerging markets and new therapeutic areas is a key priority.

Ray Goff Director, Vaccine Production Pfizer, spoke to Pharma IQ about increased time spent implementing a clinical supply in the BRIC countries: “What we are finding is going to those countries takes more time just right now, especially Russia and the Ukraine,” he said. If pharmaceutical and biotech companies don’t want to lose quality when accelerating clinical trials it is important they remain aware of global standards among all stakeholders along the clinical supply chain. This requires a pharma business to enter into more stringent monitoring and quality assurance activities, when quality cannot be assured the result is additional cost. “In Brazil we are being asked to ensure that everything is monitored and that there is proof of monitoring. In the area of cool chain that’s going to require a little more diligence from us and we are seeing the timeline going much longer and any of the customs or logistics challenges need to be dialled into to all your estimates for supplies. At the same respect if that doesn’t happen, you may end up getting more excursions which will require more supplies from you,” Goff said.

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