Serious Adverse Event (SAE) Management, Review and Reporting to DCGI during the COVID 19 Pandemic for an Ophthalmology Clinical Study

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Patient safety management is a crucial responsibility for Sponsors and Contract Research Organizations during the conduct of clinical trials. The recent COVID-19 pandemic has put forward more complex challenges for all stakeholders to complete adverse event handling and reporting.

This case study describes the key challenges, outcomes, and best practices used for timely handling and reporting of serious adverse events to the Drug Controller General of India (DCGI) during the COVID-19 pandemic without any protocol violations or deviations.

Fill the form to find out how Techsol completed Serious Adverse Event (SAE) Management, Review, and Reporting to DCGI during the COVID-19 Pandemic for an Ophthalmology Clinical Study.

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