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:

 

“The Emtex medical writing team exceeded my expectations in their development of a series of Risk Management Plans. I was very impressed with their expertise.”

Director Medical Writing