Support DSMB, Interim and DMC meetings (Charter, member, data presentation, meeting report)

For some studies the safety data requires closer follow-up during the course of the study. A Data Safety Monitoring Board (DSMB) or Data Monitoring Committee (DMC) can be installed to review cumulative safety data at regular time points. The Emtex statistician can support with the writing of the DMC Charter and presenting (un)blinded safety data reports to the DMC, as well as the blinded and unblinded meeting reports and finally the study recommendations.

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We would like to thank you thoroughly and emphasize that we very much appreciated your review. Both we and the sponsor have repeatedly stressed during the meetings that your review has been a great value to the quality of our documents. Thank you for this collaboration!

Clinical Research Associate

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