PRA’s record of accomplishment in program management and drug development in infectious diseases (ID) is clear to see. Our global experience includes services leading to the approval of two important ID vaccines: ACAM 2000™ for smallpox and Yf-Vax® for yellow fever.
Experience and Expertise
Over one-third of PRA's project management and clinical operations employees are experienced in ID clinical research.
Since 2006, PRA has conducted:
- Over 200 Phase I-IV studies and 100 consulting projects in 35 ID indications
- Phase I-IV clinical trials involving over 1800 sites and nearly 38,000 subjects
Our study experience includes indications within vaccines, anti-bacterials, anti-virals, anti-fungals and anti-parasitics.
Key areas of ID Expertise
Medical Informatics
PRA’s analytical Medical Informatics (MI) tool supplements our therapeutic expertise and practical experience with data derived from:
- Laboratory, pharmacy, EMR, diagnostic and other databases
- The MI group provides data related to natural disease histories, study protocol optimization and contextual informatics for site selection or enrichment of site-specific populations.
Feasibility Studies
PRA’s Feasibility group gathers real-time ID survey data to identify suitable regions as well as appropriate clinics and patient populations.
PRA’s advantages include:
- Familiarity with ID investigators worldwide and the types of patients they treat, disease states and other key factors facilitating optimal site and patient selection
- Ability to combine existing available data (including investigator metrics, study performance, and Medical Informatics) with direct investigator feedback to minimize study start-up time
- PRA utilizes US claims data to determine investigator locations as well as associated patient counts
- All ID activities are coordinated through PRA’s own dedicated Infectious Diseases Research Center
