The Clinical Research Directorate supports clinical research and special projects for the Frederick National Laboratory and for institutes in the National Institutes of Health, including the National Cancer Institute, National Institute of Allergy and Infectious Diseases, National Center for Advancing Translational Sciences, and others.
We support management, pharmacovigilance, protocol development and navigation activities for clinical trials. Our staff of dedicated and professionally diverse clinical research professionals provides patient care services to clinical programs.
Our teams facilitate quality assurance in vaccine and biological agent production, manage the collection and analysis of tumor and normal tissue on a molecular level and develop standardized approaches to the acquisition of tumor samples.
The program supports and performs assay development and research analyzing nucleic acids (genomic, transcriptomic, and metabolomic) and proteomics for epidemiologic evaluation of and treatment assignment for patients with cancer, HIV/AIDS and other infectious diseases. We also provide technical project management expertise in support of contracts for drug development.
We advance the field of precision medicine using next-generation sequencing, directing targeted agents to treat malignancy and support the development of agents to address rare diseases and unmet medical needs.
NCI Patient-Derived Models Repository
Providing support and innovation to elevate clinical research
The Clinical Research Directorate conducts quality control and collaborative standardization efforts that others cannot readily perform. We establish standard operating procedures and data annotations for use by colleagues downstream.
We perform quality control services for FNL's Vaccine Clinical Materials Program and the Biopharmaceutical Development Program before each begins the manufacturing process, and follow through on all regulatory aspects of production, including support for investigational new drugs.
We support the Cellular Therapy Program of the NCI Surgery Branch. This includes quality assurance/quality control, cellular manufacturing, and vector production.
Our clinical support staff helps the National Institute of Allergy and Infectious Diseases meet its clinical research objectives. These professionals include protocol nurse coordinators, nurse case managers, nurse practitioners/physician assistants, clinical research nurses, associates and technicians, and patient care coordinators, and patient recruiters.
