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Argentinian
Institute for Evidence Based Medicine |
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Purpose
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IAMBE is a non profit organization devotes to design, manage, and conduct Phase I through Phase IV clinical trials, ever mindful that quality, time, and cost are critical to sponsors. Our approach focuses on effective, mutual communication, partnership, and flexibility in developing strategies with your specific needs in mind. We have large experience acting as SMO (study management organization).
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Clinical trial monitoring |
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The best way to avoid expensive problems with your clinical development program is to use experienced clinical trial monitoring teams. Our teams have strong healthcare backgrounds and is lead by an acredited ISO 9000 individual.
IAMBE recognizes the need for educational programs to prepare and update clinical trial monitors in all aspects of their work. Our team of medical and scientific professionals is able to identify potential investigators and maintains a database of investigational sites. We can design, manage, and conduct comprehensive investigator meetings for multiple-site studies.
We are experinced in conducting site evaluation visits, site initiation visits, periodic monitoring visits, and study termination visits as well as all in-house monitoring functions, including adverse events reporting, and clinical trial material management.
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Medical monitoring
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To enhance regulatory compliance in Argentine, IAMBE has experienced personnel in regulatory affaires, including the following topics: reporting serious adverse effects, according to IAMBE SOPs and Regulatory agency requirements; clarifying inclusion/exclusion criteria with the investigators; providing consultation for potential safety issues or medical concerns regarding the clinical study.
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Data management |
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Our staff includes data management and statistical experts who manage and analyze all types of studies from simple to technically complex. Our goal is to provide sponsors with statistical reports and analyses of absolute integrity-good work done right the first time. . The statistical summary and data displays include data analyses, summaries, listings, and CRF tabulations that conform to the regulatory agency guidelines for
submissions
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Audit and compliance
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IAMBE expert auditors perform a diverse range of audits. We also perform independent, third-party audits for compliance with cGCP.
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Activities
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Currently we are the Regional Co-ordinating Centre for Latin America for the Amnioinfusion trial and for the CRASH trial (corticosteroid after acute head injury).
IAMBE most relevant large clinical trial participation was in the Magpie trial (Lancet 2002;359:1877-90) and Oracle (Lancet 2001;357:979-88 and Lancet 2001;357:989-94). Other IAMBE team members had been related to other large clinical trials, as the Episiotomy trial (Lancet 1993;342:1517-9), Eclampsia trial (Lancet 1995;345:1455-63), Retained Placenta trial (BJOG 1998;105:179-85).
IAMBE apply a lot of effort in teaching activities to disseminate Evidence Based Medicine approach. Is recognaised as affiliated centre of the Centre for Evidence Based Medicine of the University of Oxford (UK), and also representative for Argentina of the Critical Appraisal Skill Programme. It is also considered as place of work for the National Council of Scientific and Technical Reasearch (Conicet).
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