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Clinical Research

Services


Clinical Research

Services

Why work with INFANT?

What do we offer to the investigators?

Who do we work with?

• Ten years of experience in developing scientific initiatives that translate laboratory findings into medical interventions that directly improve the welfare of the community. • Solid infrastructure, knowledge and expertise in the clinical research field to collaborate with the investigators. • INFANT’s team is composed by worldwide renowned investigators with the highest ethical standards deeply committed in every project. • Continuously trained investigators and staff ensure compliance with international and local quality standards, requirements and policies. • Outstanding record of publications in the most renowned journals (N Engl J Med, Nat Med, PNAS). • Strongly supported by highly recognized national and international organizations.

• Highly competitive fees and time efficient procedures without compromising quality of the research. • Tailor-suited services to meet every investigator ’s needs and goals. • Epidemiological and study design support. • Identification and selection of sites. • Logistic and clinical planning. • Regulatory set up and maintenance. • Implementation of research projects. • Clinical and quality assurance and monitoring according to ICH GCP. • Data management and statistical support. • Support to the principal investigator (PI) in the clinical study budget development and writing research grants and proposals.

We work with an organized, trained and vibrant network of 34 hospitals in Argentina and in Brazil that provides coverage to more than 5 million children and adults. We work in collaboration with: • Public and private hospitals. • That provide care from low to high socioeconomic status populations. • From temperate to tropical to weather.


INFANT offers the opportunity to conduct your research studies in Argentina and Latin -America according to your goals and needs and with the highest ethical and quality standards. With a solid infrastructure, knowledge and expertise in the clinical research field, INFANT provides a comprehensive service that allows you to conduct your projects successfully in the most cost-effective and timely manner.

Our investigators work with: National institutions: • National Council of Scientific and Technical Research (CONICET) • Ministry of Science, Technology and Innovation • Ministry of Health • Institute for Clinical Effectiveness and Health Policy • Fundación Bunge y Born • Fundación Navarro Viola International institutions: • Vanderbilt University • Vanderbilt Vaccine Center • Vanderbilt Vaccine Research Program • National Institute of Environmental Health Sciences (NIEHS) • National Institute of Allergy and Infectious Diseases (NIAID) • Thrasher Research Fund • Bill & Melinda Gates Foundation • UBS Optimus Foundation • Georgetown University • Pontificia Universidad Católica de Porto Alegre, Brasil

Infrastructure

State of the art laboratory Logistics and sample management Administrative area with international experience in clinical research Regulatory affairs division Quality Assurance and monitoring division

Scientific accomplishments: • Outstanding record of publications in the most renowned journals. • International awards and grants.

The

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Pediatric Hosp ita with 2009 H1N1 lizations Associated Influenza in Ar Romina Libster, gentin

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M.D., Jimena Bug Diego R. Hijano, na, M.D., Silvina M.D Coviello, M.S., L. Cavalieri, M.D ., Mariana Dunaiewsky, M.D ., Natalia Reynos ., Maria C. Gug o, M.D., Maria lielmo, M.D., M. Gilligan, M.D., Soledad Areso, Fernanda Santuch M.D., Tomas Gabriela L. Gre gorio, M.D., Rina o, M.D., Graciela Cabral, M.D Alicia L. Panigas ., Moreno, M.D., i, M.D., Liliana Mar ia I. Lutz, M.D Saligari, M.D., ., Rodrigo M. Egü Mauricio T. Cab es Almeida, M.D allero, M.D., Maria D. Neder, ., Maria E. Gut M.D., Maria C. ierrez Meyer, M.D Dav ., enport, M.D., Valeria S. Santidr Maria P. Del Vall ian, Mercedes Gar M.D., Guillerm e, M.D., cia Domínguez, ina Mosca, M.D M.D., Liliana Alva ., Ana Pota, M.D rez, M.D., Patr ., Norma Bolo icia Landa, M.D ñati, M.D Victoria I. San ., chez Mercol, M.D ., Ricardo Dalamon, M.D., Juan Carlos Peu ., Marco Esp chot, M.D., Arie l Karolinski, M.D inoza, M.D., Ana Borsa, M.D ., Miriam Bruno, ., Fernando Ferr M.D., ero, M.D., Ph.D Margarita Ram ., Angel Bonina, onet, M.D., Lidi a C. Albano, M.D M.D., Elias Alterman, ., Nora Lue M.D., James D. Chappe Vilma Savy, Ph.D., Elsa Baumei dicke, M.D., ll, M.D., Ph.D., ster, Ph.D., Kathryn M. Edw Guillermina A. Melendi, M.D., ards, M.D., and Fernando P. Polack, M.D . A bs t r ac t

Background

While the Nor thern Hemisph ere braces for enza A (H1N1) the effect of the virus, data from 2009 pandemic the recent infl sphere can prov influ- The auth uenza season in ide important ors’ affiliations the Southern Hem information on Methods the burden of i- Appendix. Address repriare listed in th disease in chil nt requests Dr. Polack at dren. Vanderbilt Vacc We conducted ine Cente Department a retrospective of Pediatrics, case series invo the lower resp Vanderbi Univ ersit lvin y, 1161 21st Ave., iratory tract or g children with D-7235 MCN fever in whom Nash acut on reverse-tran ville, e infe TN ction of 37232, or at 2009 H1N1 infl scriptase polymer fernando.p .polack@vande uenza was diag ase-chain-react to one of six ped rbilt.edu. nosed ion assay and iatric hospitals who were adm serving 1.2 mill admission and itted Drs. Libster, Bugna, and Covie ion children. We death among llo contribthese children uted equally to compared rate dren who had this article. with those amo s of been infected ng age-matched with seasonal influenza strains Results chil- This article (10.1056/NEJMo in previous year a0907673) was published s. Between May on December and July 2009, 23, 2009, at NEJM.org. a total of 251 H1N1 influenza. children were Rates of hospita hospitalize liza in 2008. Of the N Engl J Med 2010. children who wer tion were double those for seas d with 2009 Copyri ght © 2010 Massa e hospitalized, tensive care unit onal influenza chusetts Medic 47 (19%) were , 42 (17%) requ al Society. admitted to an ired overall rate of deat mechanical vent inh was 1.1 per 100 ilation, and 13 children for seas (5%) died. The ,000 children, as compared with onal influenza in 2007. (No ped 0.1 per 100,000 sonal influenza iatric deaths asso were reported in 2008.) Most ciated with seapoxemia in infa deaths nts under 1 year of age (death rate were caused by refractory hyConclusions , 7.6 per 100,000 ). Pandemic 2009 H1N1 influ


What is INFANT? Fundación INFANT is a non-profit organization established in 2003 to translate laboratory findings into preventive and therapeutic medical interventions that promote pediatric health. Our scientific findings have been published in prestigious journals around the world including: The New England Journal of Medicine, Nature Medicine, Pediatrics, and the American Journal of Respiratory and Critical Care Medicine.

Who are we?

Fernando P. Polack, MD Scientific Director Cesar Milstein Professor of Pediatrics at the Vanderbilt Vaccine Center & Division of Infectious Diseases at the Department of Pediatrics of the Vanderbilt University (Nashville, USA). The “Cesar Milstein” name was given for the late Argentine scientist who won the Nobel Prize in medicine in 1984. He was a faculty member of the Departments of Pediatrics, Immunology and Molecular Microbiology and International Health at Johns Hopkins University (Baltimore, USA). Dr. Polack has received several important awards which include: E. Mead Johnson Award for Research in Pediatrics (2010) / Young Investigator Award, Society for Pediatric Research (2006). In 2009 the City Legislature in Buenos Aires recently gave him the honorary title of “Distinguished Citizen in the Field of Sciences”.

Romina Libster, M.D. Medical Investigator Division Head of Clinical Research Services Division Head of Clinical Research Services at Fundación INFANT. Dr. Libster received her Doctor of Medicine, with High Honors from the University Of Buenos Aires School Of Medicine in 2004. Upon completion of the pediatric internship and residency training she began a Post-Doctoral Research Fellowship at Fundación INFANT and the Master in Clinical Effectiveness Program. Under the mentorship of Dr. Polack and working with colleagues around Buenos Aires, she characterized the clinical and laboratory manifestations of the 2009 Pandemic Influenza A (H1N1) in Argentina within three months of initiation of the pandemic and reported it as a first author publication at The New England Journal of Medicine (Libster R et al. N Engl J Med 2010) as well as the following 2010 influenza season (Libster R et al. N Engl J Med 2010). She joined the Vanderbilt Vaccine Research Program‘s team at Vanderbilt University (Nashville, USA) in 2009 where she performed a Post-Doctoral Research Fellowship in the field of Vaccinology and Vaccine Preventable Diseases and participated in CDC and NIH funded studies. Since 2009 is coordinating a Phase 4 multi-center clinical trial sponsored by the NIH-funded Vaccine and Treatment Evaluation Unit to evaluate the safety and immunogenicity of sequential schedules of the two licensed rotavirus vaccines.

INFANT has a multi-disciplinary team including biologists, physicians, biochemists and biotechnological engineers.

Contact information:

www.infant.org.ar

Romina Libster, M.D. rlibster@infant.org.ar

www.facebook.com/infant.org.ar

twitter.com/fundacióninfant

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