WATERMARK: Pharmaceutical, Biotech and Med Devices Safety Oversight

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WATERMARK DSMB

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DSMB, IDMC, Adjudication Panels, Post-Market Safety, Outcome Registries.

Regulatory Audits

An audit can occur at anytime on your new product by a number of governmental agencies.  These audits are most common during a clinical trial but may also occur prior to IPO, changes in investment capital, and corporate spin offs.  Watermark has experience with audits.  We provide all the support and information to ensure the DSMB portion of your audit is complete.  We respond immediately to the regulatory agencies, providing information and documentation to show complete independence of the committee and proper documentation of all proceedings.

All audit support is included in our work with the data and safety monitoring boards.

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