Clinical Resarch
Within the clinical research department, all efforts are invested according to the most up-to-date standardized procedures (SOP) to deliver services of feasibility of research project, protocols elaboration, submission to regulatory authorities, implementation, monitoring, validation and coordination of clinical biology services, pharmacovigilance monitoring , reporting and reconciliation of events , IMPs management , data verification and storage ; site closures and medical writing of end of study reports.
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Data Management
Our CDMS is adaptative to both methodology used , paper data collection or electronic data collection. Our data validation process is comprehensive and robust .Minimal requirements for data management should be regarded as the starting level to be able to participate in common trial activities . In this sense, minimal requirements identify the level of minimum quality standards that could be assured to external partners wishing to make use of the abilities of Poseidon CRO . This level is defined clearly and explicitly, so that system audits can be performed easily ...
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Biostatistics
Beyond usual services to industry , such as subject number determination , protocol conception, data analysis , models verification , our biostatistics and bioinformatics buisness unit provides statistical advice and support to researchers during the preparation and the implementation of project proposals. The objectives are to maintain the high quality of clinical research and improve the statistical skills of collaborators , in classical fields ( epidemiology , clinical research ) but also in exciting new challenges such as biosimilars and drug design ...
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Biomarkers, Central Lab and Clinical biology services & QA
Biomarkers nowadays are largely applied to drug development in a number of distinct ways. First, they may be applied as additional diagnostic measures in a population clinically identified as having the disease. Sensitivity, specificity, and positive predictive value all must be considered for such an application.One of the most important uses of biomarkers in drug development is as an indirect measure of disease severity. A number of points should be established for such use: the marker must have a scientific rationale , it should change with disease progression in longitudinal observational studies, and must be measurable and reproducible.
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Training Services
Clinical trials are an enormous undertaking. They can involve thousands of people, tens or hundreds of investigative sites, multiple CROs, and various stakeholders systems interacting and all generating massive amounts of data and processes . Achieving excellence in such a complex action is not a luxury, it's a must . That's why we select reputable and efficient trainers and offer comprehensive uptodate training services to all levels , entities and personnel pertaining to clinical studies ...
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