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Optimizing Global Safety Reporting in Clinical Trials

In 2011, the FDA issued guidance on the reporting of adverse reactions in clinical trials, which called on trial sponsors to issue fewer, more informative reports. The results of a recent survey conducted by the Clinical Trials Transformation Initiative (CTTI), published in Clinical Trials, show that although sponsors embrace the guidance, they’re finding it hard to put into practice. Fearing both regulatory repercussions and organizational challenges, sponsors continue to inundate investigative sites with numerous non-actionable reports. Investigators are forced to endure this barrage, but at the expense of patient safety.

How do we break this inefficient—and ineffective—cycle? ePharmaSolutions (ePS) offers a technology-enabled solution that streamlines the global safety reporting process, saving clients millions of dollars while increasing patient safety.

Learn how a large, global pharmaceutical company saved millions of dollars by optimizing their safety reporting process. Join industry experts, Kendra Hayden of Hoffman-La Roche, along with Steven Beales and Kristy Fusco of ePharmaSolutions, for this one-hour webinar during which they explain how streamlining this burdensome process can actually increase patient safety.

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How Roche Optimized its Global Safety Reporting Process for Clinical Trials
How Roche Optimized its Global Safety Reporting Process for Clinical Trials

Roche recognized several major challenges that its CTSP 2.0 system needed to address.