
Developing the vaccines, drugs, and diagnostics needed to combat emergent infectious and immunologic diseases requires robust clinical trials expertise to transition candidate therapeutics from lab and animal models into clinical testing, and ultimately to those patients who are in need. The clinical trials stage of development provides the definitive safety and efficacy information required for the U.S. Food and Drug Administration (FDA) to approve a therapy or vaccine’s use in the broader population. Combating emergent infectious diseases also requires coordinated surveillance activities to detect, characterize, and respond to outbreaks rapidly. CAMRIS has experience working with over 60 infectious diseases and select agents in operational pathogen detection and diagnostic surveillance programs and has conducted clinical trials for novel vaccines. Our expertise includes infectious disease research, global detection, lab diagnostics, BL-2/3 lab operations, and data and IT management. And we have a presence in 35 countries supporting infectious disease research (e.g., malaria and Zika), and longitudinal health studies.
Our research teams have extensive experience designing, planning, executing Phase I – IV clinical trials, from the initial pharmacokinetic and pharmacodynamic characterizations to multicenter, randomized, double-blinded, and placebo-controlled trials. Our clinical trials expertise includes coordinating training and patient activities, tracking volunteers and patients, managing test articles, handling and storing specimen, and conducting clinical site monitoring. CAMRIS researchers and scientists have applied their expertise to support an array of clinical research studies aimed at delivering strategies to prevent and treat infectious and immune-mediated diseases through drugs, vaccines, adjuvants, and other forms of immunotherapy. Our scientists also support surveillance activities to rapidly identify and respond to emerging threats, whether naturally occurring or deliberately introduced as an act of bioterrorism, by characterizing resistance patterns, providing lab support during outbreak investigations, and identifying new cases of antimicrobial resistance. CAMRIS scientists have made significant contributions to advance the fields of vaccine and immunologic research, and, in turn, to enhance the health and well-being of communities in the U.S. and worldwide.
Emerging and endemic infectious diseases, such as Ebola and Zika, pose a significant threat to global public health. Our health and medical research efforts in Africa, South America, and Asia have provided us with unique scientific, programmatic, and data management expertise specific to the identification and characterization of infectious diseases.
One of the final steps in drug development and delivery is human safety and efficacy testing via clinical trials. The success of these clinical studies is dependent not only on the drug but also on the capability and experience of the staff executing the trial.
Mounting scientific evidence suggests that chronic inflammation is not only associated with, but also is causal in an array of diseases, including cardiovascular disease, obesity, and dementia.
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