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Collaborating with a Large CRO


Case Study # 1: Collaborating With a Large CRO

In a pivotal trial that was ongoing in 11 countries and was managed by a U.S. based large CRO, worldwide recruitment rates were slow. Consequently, the large CRO chose to open 7 sites in India through its Indian operations. At this point, the sponsor also approached TMI to see if we could assist the larger CRO. As our costs were significantly lower and our sites were more remote, we were authorized to open eight sites independent of the large CRO. As the trial commenced in India, the large CRO as well as the sponsor were pleased with our model and deliverables. Consequently, in a collaborative manner, TMI took over managing the sites that the large CRO had identified while the large CRO focused more on monitoring.

In our conversations with clients, they often have identified a CRO in the U.S. or Europe to manage that geographical phase of their studies. Although the CRO may have a base in India, our model in site management and our understanding of local cultural and demographic factors has made us a preferred choice in partnering with the large CRO.