Reporting to Ethics Committee/ IRB and Regulatory Authority
Monitoring of adverse events is one of the most important values in conducting clinical trial, for the protection of the subjects enrolled in the trial as well as protection of the patients and proper use of the drug once it is marketed. At the same time, safety reporting is one of the most difficult things for a study site to do correctly in proper time.
Prodia the CRO as extension of your team, provides you to review safety data throughout a trial by reporting adverse events that are serious, related, and unexpected to the Ethics Committee or regulatory authority within the expedited reporting time frames.
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