Right Science, Right Patients, Right Data
Our team has considerable clinical research experience addressing the prevention and treatment of emerging infectious diseases (EID) and chemical, biological, radiological, and nuclear (CBRN) threats. ID is a business focus for Navitas Clinical Research, Inc., and thus, we have formed strategic partnerships with several infectious disease experts.
We have supported ID clinical studies for seven National Institutes of Health Institutes and the U.S. Food and Drug Administration (FDA), as well as a Biodosimetry After Radiologic and Nuclear Events trial for the U.S. Department of Health and Human Services and the Centers for Disease Control and Prevention’s pre- and post-influenza vaccine sera panels. We prepare and execute clinical research from pre-study activities through implementation, closeout, and analysis.
We provide the follow types of support for our ID studies:
- During planning, we develop all study materials and processes related to study implementation.
Throughout the implementation phase, we work with the sites to ensure they are executing procedures as required.
- We manage the sites enrolling the patients, collecting the blood for pre-immunization serum samples, and administering the vaccine.
- We oversee processing and aliquoting pre- and post-immunization samples, record keeping, and shipment of serum samples for testing.
- We conduct study monitoring and close-out visits to ensure all regulatory requirements are met and documents stored as required.
- Finally, we conduct statistical analyses and prepare Clinical Study Reports that describe the study’s findings.
In addition, we support regulatory interaction with FDA for medical device approval and provide training in Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and Good Manufacturing Practice (GMP).
Work with us. Contact us to learn how we can find the right solutions for all of your clinical research needs.