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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Customer testimonial:

 
“I wanted to express my gratitude to you and the entire Emtex team for your great support and partnership. I know it has been a demanding year on so many levels but the professionalism and quality of work from Emtex never wavered”

Global Head Regulatory Medical Writing