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.

Patient Derived Models Repository workflow
Researcher Resource

NCI Patient-Derived Models Repository

Our Molecular Characterization Laboratory conducts all next-generation sequencing (NGS) and profiling for tumor models in the NCI Patient-Derived Models Repository, which is managed by Frederick National Laboratory’s Applied and Developmental Research Directorate. Our laboratory also reviews and confirms the histology of all mouse models of human tumors held in the repository.
Additional Content

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.

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Research resources for internal and external investigators
Several of our teams manage repositories and biobanks available to investigators as part of a larger collaborative effort.
Network illustration
We facilitate teams within collaborative networks and special initiatives directed by groups within the National Institutes of Health.
Scientist working under a safety hood at a workbench
Collaborative Initiatives
We facilitate teams within collaborative networks and special initiatives directed by groups within the National Institutes of Health.