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 can really trust the Emtex writers to deliver a quality document on time, to reach out to me or team members when appropriate, and to adapt to our changes in process/template over time. The consistent quality of work– and that this is true of all the writers. The willingness and ability to learn and improve. The good balance between independent work and reaching out to me or the team when appropriate. The effective and friendly communication.”

Senior Medical Writing Leader

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