Creating Approaches for Quality Assessment for Clinical Research Cro¿s - c, Ramesh;Ramesh, Swetha
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Pharmaceutical companies recognize the benefits of carefully managing the quality of data from their drug development and clinical trials. Although study requirements are carefully set forth initially in detailed documents such as an approved clinical protocol, a data management plan, and an accompanying project plan, expectations and requirements can change during a study. Quality Assurance and Quality control approaches are different in each organization, and careful blending of the approaches and process contributes to the organization's success and efficiency. The present studies are…mehr

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Produktbeschreibung
Pharmaceutical companies recognize the benefits of carefully managing the quality of data from their drug development and clinical trials. Although study requirements are carefully set forth initially in detailed documents such as an approved clinical protocol, a data management plan, and an accompanying project plan, expectations and requirements can change during a study. Quality Assurance and Quality control approaches are different in each organization, and careful blending of the approaches and process contributes to the organization's success and efficiency. The present studies are designed to assess the importance of QA and QC approaches and to what extent these QA/QC models would influence different CRO activities In this present study a list of 10 leading CROs of India were identified and a questionnaire survey study was conducted by administering validated Questionnaire with 30 employees each from these CROs representing equally the lower, middle and top-level Management in these CROs and data obtained through questionnaire survey were tabulated and subjected to statistical analysis.
Autorenporträt
El Dr. C. Ramesh es un profesional muy competente con más de 25 años de experiencia en la enseñanza, el aprendizaje y el desarrollo de la formación, la investigación clínica y la garantía de calidad, el control de calidad y la gestión de proyectos. Ha realizado importantes contribuciones a la investigación de medicamentos y ha dirigido muchos programas de formación para que los profesionales comprendan mejor los ensayos clínicos.