Committee Composition
We can establish a DSMB for your project or help manage an existing board. We work to provide you with a list of potential board members based on therapeutic expertise and clinical trial experience. The ability of the board members to understand clinical trials and have a therapeutic expertise is paramount to the board’s efficiency and the review of data. WATERMARK has extensive experience providing services to data and safety monitoring boards. We provide all the forms needed for FDA compliance including the disclosure forms, open and closed meeting minute templates, and board charter.
Committee Independence
The board and all members must be independent of the study and product in question in all regards including:
• research participation
• financial interests
• supportive activities
We ensure that all board members complete and sign financial disclosures as well as disclosure of speaking or other consulting activities. These disclosures help document and ensure there is no conflict of interest in review of your data. All information on board members are updated yearly to ensure the most accurate information is available.
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