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India: Give or Take?

With its vast pool of patients and well-trained, English-speaking investigators, what exists to take advantage of in this research-rich country is clear. What needs to be given back, however, is not so clear. Despite the uncertainty, one thing seems evident: Responsibility is key to giving back.

Beyond Blockbusters

While not a panacea, pharmacogenomics is still a valuable trial tool that can make the recruitment process more efficient and eliminate the high costs associated with late-stage product failure.

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The EDC Decision

Boehringer International implemented a holistic approach to electronic data capture, boosting quality and efficiency.

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Much has been written about the staggering costs of drug development and how the low Phase III success rates across the pharma industry have contributed to these costs. While safety outcomes explain many failures during the early development phase and have likewise played a prominent role in some highly publicized product withdrawals, efficacy failures in Phase III have received little attention. What we now know, however, is that a significant number of Phase III failures are attributable neither to issues of safety nor product differentiation, but to an inability to confirm efficacy against placebo.