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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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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Pharmaceutical companies has come to outsource non-core activities in an effort to control costs and enhance drug-development cycle time. One of these activities is medical writing—an area that, although not at the core of pharmaceutical operations, has become increasingly critical as regulatory agencies have adopted more elaborate review measures that require substantial amounts of documentation. Through its team of highly qualified and knowledgeable professionals, our CRO is a trusted partner in all areas of medical writing ...
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Because of the highly technical, sensitive and regulated nature of medical texts added to the necessity that most countries around the world require that literature and labeling associated with medical devices or pharmaceuticals sold have to be translated into their national languages , we are deploying our best practices to assist you through this field. We perform the translation of technical, regulatory, study , clinical or marketing documentation, software or training content for the pharmaceutical, cosmetics , medical device or healthcare fields , for a large variety of sponsors and partners ...
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