Statistical monitoring of studies


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A particular strength of Statistics Collaborative, Inc. is our experience in statistical data monitoring for multicenter randomized clinical trials. We have provided interim monitoring of several blinded trials. In some cases, we have managed the Data and Safety Monitoring Boards.

  • For a large biotechnology company developing treatment based on monoclonal antibody research, we served as the interim monitoring center for a study of meningococcemia. We were responsible for randomization, monitoring safety, convening the Data and Safety Monitoring Committee, and performing analyses of the data for submission to the FDA.
  • For a large pharmaceutical company, we performed the interim data monitoring for a study of a psychotropic agent.
  • For a large pharmaceutical company, we have performed the interim safety and efficacy monitoring for cardiovascular studies.

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