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BioMedica Research Group -­ General Overview


The mission


The mission of BioMedica is to perform research activities based on good clinical practices (GCP/ICH), fulfilling local regulations, the Food and Drug Administration (FDA) and the European Medicine Agency (MEA) requirements. Through our sister institution PsicoMedica, our professional staff provides clinical services for the general public, and continued medical education for health professionals. Our vision is to become a leading Multispecialty Research Center and to contribute to the development and recognition of this important health field. We are also part of academically oriented research in collaboration with local and overseas universities (Universidad de Chile, P. Universidad Cat¢lica de Chile and Heidelberg University).

Our group


Our group established a research site more than a decade ago (1999), initially carrying out clinical studies in the neuroscience field and most recently in additional medical areas. As for March 2013 we took part in 90 international multi-center trials (78 in the CNS field, 12 in other specialties), phase 2 to 4, in the following diagnostic populations: Alzheimer?s Disease, Anxiety Disorders (GAD, Panic, PTSD, Social Phobia), Depressive and Bipolar Disorders, Epilepsy, Insomnia, Migraine, Multiple Sclerosis, Parkinson Disease, Personality Disorder, Schizophrenia, Cardiovascular/Metabolic, Diabetes Mellitus 2, Respiratory and Infectology.


In the vast majority of the trials we have succeed to enroll the number of assigned patients and in many studies we were recognized as high enrollers. In a recent MDD protocol we performed as the top enroller site worldwide; most importantly, we were also able to preserve the integrity and quality of the data. Our site has been successfully audited, with no major findings, in 11 separate studies (both by sponsors and QA CRO?s departments), and by the local regulatory authority, Instituto de Salud P£blica (ISP).

Our sponsors


Our sponsors have been Astra -Zeneca, Bial, Eisai, Eli Lilly, Forest, GSK, Johnson & Johnson, Medivation, Merck (MSD), Novartis, Organon, Otsuka, Pfizer, Roche, Sanofi, Cerecor, Servier, Shire, Schering-Plough, Solvay, Takeda, Toyama and Wyeth. The following CRO took part in several of the above-mentioned studies: Covance, Icon, I3, INC, PPD, PAREXEL, PRA and Quintiles. The central laboratories we have worked with are Biomedical Systems, Covance, ERT, Hidalgo, MRL, Quest Diagnostics and Quintiles. We are familiar with most e-CRFs (eClinical, Inform, Oracle, RAVE) and IVRS/IWRS systems (ClinPhone, Clarix, CORE, Impala, RAMOS, Perceptive).

BioMedica


BioMedica has a permanent staff of 30 professionals, including the following medical specialties and sub-specialties: Cardiovascular Disease, Dermatology, Diabetes and Metabolism, Family Medicine, Gynecology, Internal Medicine, Neurology/Dementia/Epilepsy/Sleep Medicine, Psychiatry Adult/Child and Adolescent, Ophthalmology and Pulmonary Disease. We are actively seeking to expand to additional medical areas, such as Rheumatology, Urology and ambulatotory Oncology. Our staff includes also 4 registered nurses (SCs and study nurses), R&D consulting, health technicians and administrative personnel. The PI responsibility is assigned to an MD whose specialty/sub-specialty is in the research area of the study so is the physician in charge of the patient. General research activities (i.e. feasibilities, regulatory activities, budget issues) are centralized through a Research Director/Senior Coordinator.


Institutional headquarters are located in a traditional medical neighborhood in Santiago, Chile. The facility has all the requirements for clinical trials and GCP compliance; consultation and monitor offices with broadband Internet access, comfortable waiting rooms, fully equipped and sanitary approved areas for laboratory and medical procedures, along with a temperature and access controlled drug storage room and independent archive facilities. Access is expeditious and a parking area is available. BioMedica has a strong commitment to be a leading participant in the clinical trials scientific community and to make a permanent contribution to the progress of the field in Chile and Latin America.

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