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"Safety Reporting in Clinical Trials: Six Core Considerations for Success"

PPD FSP Pharmacovigilance Solutions

In the realm of clinical trials, the paramount concern is patient safety. This commitment to safety is built on the cornerstones of meticulous monitoring and reporting of adverse events.
As investigational products progress through the phases of clinical research, the landscape of pharmacovigilance becomes an intricate global network, demanding continuous adaptation, meticulous planning, and expert execution.

This white paper delves into the complex and evolving world of safety reporting in clinical trials. It uncovers the challenges faced by sponsors as they traverse the web of multi-national, national, and local entities, including Regulatory Authorities (RAs), Ethics Committees (EC), investigator sites, and business partners.

With a focus on six core considerations, this paper navigates the terrain of pharmacovigilance to facilitate a deeper understanding of the pivotal role played by safety reporting in clinical research.

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