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CLINICAL TRIALS
The management of Clinical Trials carried out by a team of experts team guarantees the quality, veracity and traceability of the and traceability of the data obtained, in compliance with health ethical standards and scientific methodologies in accordance methodologies in accordance with the objectives and hypotheses and hypotheses set forth in the research and that will accompany the the development of the project, which will be reflected in a reduction of risks and reduction of risks and costs.
The integrated management of the activities to be carried out in the Clinical Trials Clinical Trials, involves coordination between manufacturers, sponsors, ethics sponsors, ethics committees, research centers, principal investigators, principal investigator centers, principal investigators, health authorities, specialized authorities, specialized service providers such as Electronic Case Report Format (eCRF), and clinical monitoring, centralization in a single entity, such as Scire Clinical Solutions, allows for the as Scire Clinical Solutions, allows to maintain a homogeneous homogeneous quality, as well as an improvement in the efficiency and efficacy of the actions effectiveness of the actions carried out.
Services:
• Elaborate, review, coordinate or conduct preclinical, clinical phase I, phase II and phase III protocols. preclinical, phase I, phase II and phase III clinical protocols.
• Selection of highly specialized research sites and network of network of investigators for the conduct of Clinical Trials. Clinical Trials.
• Selection and coordination of activities with ethics committees. committees.
• Clinical, analytical, pharmacokinetic and statistical monitoring in statistical monitoring in bioequivalence studies.
• Integrated management of activities for the performance of bioavailability studies, non-interaction studies, pharmacokinetic pharmacokinetic studies for new fixed combinations of active ingredients and active ingredients, and bioequivalence, performed in third party third party laboratories authorized in Mexico before the COFEPRIS.