Data Monitoring Committees

Data Monitoring Committees (DMCs) are required for a growing number of clinical trials, including those sponsored by industry and by government agencies, non-profits and international organizations. In the past, these committees have been formed and organized by the individual study sponsors on a case-by-case basis. And, although the US FDA, EMEA and other agencies have provided guidance documents, there have been inconsistent approaches to the formation and operation of DMCs, sometimes with unforeseen consequences.

Care-Safe is able to provide our clients with a consistent, professional and cost-effective approach to the formation, operation and documentation of their DMC. Our Standard Operating Procedures ensure a consistent methodology to the DMC process, and our highly experienced staff ensure that each project is approached thoughtfully, taking into account the unique features of the therapeutic area, treatment, trial design and analytic methods. Our approach results in high quality, reliable execution of DMC activities.

The backgrounds and experience of our staff allow us to:

• Evaluate the need for a DMC for a particular clinical trial or program

• Provide comprehensive project management services for your DMC, including meeting planning, study progress tracking, oversight of other third party vendors related to the DMC, and complete documentation.

• Serve as the independent, core members of your DMC. Core members may include: Medical/Safety Monitors, Biostatisticians, Epidemiologists and/or Clinical Trial/Quality Assurance experts. Depending upon the needs of the study, we will assemble the remaining members from our highly expert and recognized network of physicians, medical ethicists, clinical pharmacologists and others. We will also facilitate inclusion of experts identified by the study sponsor as desired.