FDA began accepting IND Safety Reports in E2B format, November 21. In preparation for the receipt of IND Safety Reports, FDA has posted the following… Read more »
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The FDA has published a new draft guidance to help Investigators comply with the safety reporting requirements in Clinical Trials 21-September-2021. Recently, the recommendations for… Read more »
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European Pharmaceutical Market Research Association (EphMRA) has revised the Adverse Event Reporting (AER) Guidelines in September 2021 (click here). The guideline provide the recommendations for… Read more »
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Trouble finding usable normal ranges for lab tests in clinical trials ? – this may be a solution for you. Often reference values are missing… Read more »
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For all UK MAs, including those that cover the whole of the UK or are specific to Northern Ireland or to Great Britain, the marketing… Read more »
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Signal Management A drug undergoes a variety of clinical trials before it is introduced in the market for public use. However, the clinical trials conducted… Read more »
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