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 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.
U.S. Army Medical Materiel Development Activity Office of Regulated Activities
The U.S. Army Medical Materiel Development Activity (USAMMDA) Office of Regulated Activities (ORA) provides full-service, oversight, and consultation for regulatory, clinical, non-clinical, manufacturing, data management, and biostatistics support for FDA regulated drug, biologic, medical device, and combination products. This includes full support for the joint Army Surgeon General/Department of the Army (TSG DA) sponsored products and research efforts, oversight for all TSG-DA sponsored products procured from contract research organizations, and oversight for contracted product development for non-TSG sponsored products and consultation/advisory services for non-TSG-DA sponsored activities.