Our Work
Knowesis’ regulatory affairs and clinical data management staff serve under prime contractor ICON GPHS, to provide regulatory assessment, consultation, and regulatory opinion for medical devices, drugs, biologics in the biomedical advanced development pipeline. They review all regulatory documentation for the product development effort to include reviewing, editing, and coordination of document submissions to the FDA. Our regulatory affairs staff provide regulatory expertise to integrated product teams (IPT)s for development of contract documents and statements of work for the development of medical devices, drugs, or biologic products and advise as a regulatory subject matter expert in meetings with the FDA. In addition, our data manager is responsible for the quality and integrity of clinical research data collected in support of sponsored protocols and projects. They provide oversight and consultation, participate in IPTs, develop study-specific protocols and associated databases for study data entry, data management plans and related documents. 
 
Our Results 
Our staff have successfully marshalled ORA regulatory compliance and clinical data management aspects of three products for approval. We are actively engaged with the Army and Department of Defense drugs, biologics, devices, and combination products to mitigate risk and accelerate the delivery of FDA-regulated products to support the warfighter and broader DoD beneficiary population.