iTRIALS is a scientific and site management organization that combines a sophisticated understanding of pediatric infectious diseases & immunology with a profound knowledge of the logistical implementation and public health challenges in Latin America. iTRIALS assists sponsors, CROs and investigators in all aspects of clinical trials to help ensure that goals and expectations are timely and successfully met with international quality standards.
• Internationally recognized pediatric scientists.
• Provision of epidemiological, clinical and disease-specific information for study design and burden estimates.
• Discussions with National Regulatory Authorities and National and State Health Authorities championing vaccines for disease prevention.
• Education and sensitization of investigators, study teams and health care workers on disease burden, present and future therapies, mechanism of illness and short and long term consequences of infectious diseases.
• Study team selection and organization of roles.
• iTRIALS identifies high volume clinical research sites of extraordinary recruitment potential and high quality staff.
• iTRIALS develops these sites identifying ideal team members based on previous knowledge of key personnel and extensive experience working in the region.
SCREENING AND IDENTIFICATION STRATEGY
• iTRIALS designs specifically tailored strategies for individual sites to maximize recruitment.
• iTRIALS designs the best local strategy for patient retention and compliance.
• iTRIALS continuously trains sites on GCP, local regulations and specific SOPs.
• Recruitment/ enrollment training and support activities.
Committed to timely results, iTRIALS provides regional support for regulatory processes.
• Ethics Committee submission for site.
• Ethics Committee periodic updates.
• Assistance with preparation of sites’ documentation for National Regulatory Authorities.
DATA AND STUDY DOCUMENTS
• iTRIALS ensures quality data collection and timely data entry.
• iTRIALS assists with Trial Master File Management.
Our organization has a portfolio of epidemiological and disease burden information that contributes to strategic planning of trials on site and potentially in other regions of the world. iTRIALS integrates first class pediatric scientists with state of the art laboratory facilities and more than two decades of experience in studying and treating infectious diseases.
Our team has a long history of collaborative work with regional and national authorities and is well established and respected in Latin American medical community. We advocate for the importance of preventive medicine and vaccinology using local and global evidence based information generated by colleagues and ourselves in the same regions where studies need to be conducted.
WHO WE ARE?
Pediatric Infectious Disease specialist with long-standing expertise in pediatric respiratory diseases, from basic science and translational research to clinical investigation. His interests go beyond academic research, including public engagement and health policy. He received several recognitions from prestigious institutions, including the Young Investigator Award and the E. Mead Johnson Award for excellence in pediatric research from the Society for Pediatric Research in the United States, and recognition as a Distinguished Citizen by the City Hall of Buenos Aires, Argentina.
Pediatrician with a background in public health and vaccine trials. Dr. Libster trained in the Vanderbilt Vaccine Research Program at Vanderbilt University, participated in the Advanced Course on Vaccinology (ADVAC) in France and collaborated with the Argentinean government assisting in the evaluation of vaccine and education programs in Argentina. Dr. Libster led studies of public health interest on influenza, RSV and GBS.
Biochemist with more than a decade of expertise in clinical research implementation and regulatory affairs after training in a basic science program of pediatric respiratory diseases. Dr. Coviello coordinated the Translational Science Pediatric Training Program sponsored by the Ministry of Science and Technology in Argentina and was Head of Regulatory Affairs & Quality Assurance at Fundación INFANT.
BUENOS AIRES - ARGENTINA
+54 11 4632 8189