DM-STAT, Inc. Information

DM-STAT’s primary source of revenue over the past 20 years has been through the NIH where we serve in the capacity of a data coordinating center; responsibilities include administrative/logistic support, project management, clinical operations, regulatory affairs, data management, safety reporting, data submission, and biostatistics and statistical programming. We also provide identical services for industry-sponsored clinical investigations. For both funding mechanisms, we have supported phase I through phase IV drug trials; device trials; in vitro diagnostics, laboratory developed tests and orphan drug investigations, as well as behavioral intervention, large scale observational and opportunistic studies. We believe that our experience in supporting both NIH and industry-sponsored research offers a unique perspective largely in part because NIH sponsored studies have limited funds available for on-site monitoring; requiring careful risk assessment to ensure protection of human subjects, patient safety, data quality and that FDA/regulatory requirements are met. DM-STAT's integrated approach using DM-Encompass, our proprietary clinical data management system, and associated processes (e.g., manual of operations, clinical monitor manual) has successfully provided remote support to clinical research staff from all over the world, regardless of their prior experience. DM-STAT has utilized risk-based approaches since its' inception (prior to FDA 2013 Guidance– A Risk-Based Approach to Monitoring). DM-STAT actively supports research for publication, and stays abreast of, utilizes and publishes advanced statistical approaches (e.g., modeling trajectories of exposures) to support our clients outside of what organizations serving as CROs typically provide. We are a different kind of organization, one that takes ownership, staff are cross-functionally trained and passionate and we have a unique pricing model (its’ not about change orders).