Many markets are emerging for clinical trials because the U.S. Food and Drug Administration requires "naïve patients," or places like the Ukraine to fill quotas, or even because the drug being tested might be sold into that country eventually.
The number-one emerging market is China, followed by Brazil, Russia and India. But don't discount other countries like Korea, Viet Nam, Turkey, Venezuela, Pakistan and Romania.
A successful international cold chain shipping program depends on local people you can rely upon. Typically, a first-time big problem or even numerous smaller excursions usually can be traced back to human error—and the loss of one knowledgeable "local" can be devastating. Training, and retraining is key. So whether you outsource to a CRO, or hire your own in-country person, you need "feet on the street" at the point of delivery for your international cold chain shipments to succeed.
Particularly frustrating is the fact that many countries want to extract additional revenue from you thinking you have deep pockets.
Tests that you have already done and paid for in the U.S. may be ordered in that country, but are they really required?
A local contact knowledgeable about the rules and regulations—and local culture and customs is a must.
Brazil and Argentina were cited as good sites for clinical trials, but two countries that have set high hurdles for investigational drugs. They don't make it any easier to bring in drugs in a timely manner. Worse, cooperation between countries in Latin America may be non-existent.
You may have an overage of shippers in country A and a shortage right next door in country B. But you may have to ship through the U.S. or the U.K. just to move a product a few hundred miles. This is opposed to the EU where once you have drugs on the ground, going from country to country is relatively painless.
Information for this article came from a roundtable discussion at the 10th Annual Cold Chain and Temperature Management Global Forum.
