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Regulatory Challenges in Global Clinical Trials

In the new patent era pharmaceutical companies have changed their strategy to market their products. They are launching products in multiple markets with a single shot to capture their share. In order to get an approval for marketing of their product, regulatory bodies are insisting on clinical trials of land for the safety concerns of the people of their region and suspecting and questioning the efficacy of the product.

In this scenario, the pharmaceutical companies are bound to go for global clinical trials. In contrast to routine trials, there are multiple technical, procedural, and legal hurdles in conducting global clinical trials varying from site selection to regulatory clearances to precede a trial.

Let’s discuss some of the important issues. In this situation one has to go with global thinking with local regulatory process awareness.

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