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Managing the Unmanageable: Meeting the Challenge of Appropriate Safety Report Distribution

As clinical trials become more complex and increasingly global, the problem of over-distributing expedited safety reports to investigative sites has reached the point that demands a solution. The excessive volume of safety reports can cause investigators to miss important reports lost in the noise of non-significant event reports, and sometimes cause them to reconsider participating in future studies. How can we be sure that investigative sites only receive the reports they truly need to review?

Read this whitepaper to learn about the various methods of distributing safety reports, and what solutions sponsors and CROs should look for to resolve this growing problem.
 

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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.

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Safety Reporting: It Can Enter the 21st Century, If We Let It
Safety Reporting: It Can Enter the 21st Century, If We Let It