Regulatory Guidance
WATERMARK is the first independent central DSMB. We work in the clinical research arena providing services for independent data & safety monitoring. In this role, we provide to the pharmaceutical, biotech and device companies the knowledge and services to conduct the data monitoring meetings within the FDA guidelines, which center on independence. According to the FDA guideline, "An independent DMC is a committee whose members are considered to be independent of those sponsoring, organizing, and conducting the trial." Because WATERMARK is not a CRO or a data management center, we are completely independent of your data. A Data & Safety Monitoring Board provides information early about your product and can save millions of dollars in lost time and potential damages.
Data & Safety Monitoring is a very important component in helping to ensure the efficacy and safety of new or existing products for patients. Data and Safety Monitoring can take several forms such as data monitoring committees (DMC), also called Independent DMC; clinical events committees (CEC); clinical trial steering committees and adjudication panels. Each of these boards play a critical role in determining if a study should continue or if a product is safe based on ongoing data from an independent unbiased perspective. WATERMARK supports all independent monitoring committees, following the FDA guidance for data safety monitoring committees 2006.
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