Schaffung Von Ansätzen Zur Qualitätsbewertung Für Klinische Forschung Cro'S

Pharmaceutical companies recognize the advantages of careful management of data quality in their drug development and clinical trials. Although the requirements for a study are initially outlined in detailed documents such as an approved clinical protocol, a data management plan, and an accompanying project plan, expectations and requirements can change during the course of a study. The approaches to quality assurance and quality control vary across organizations, and careful alignment of these approaches and processes contributes to the success and efficiency of the organization. This study was designed to assess the importance of QA and QC approaches and to determine the extent to which these QA/QC models influence various CRO activities. In this study, a list of 10 leading CROs in India was identified, and a questionnaire survey was conducted, involving 30 employees from each of these CROs, representing lower, middle, and upper management equally, who were surveyed using a validated questionnaire. The data obtained from the questionnaire survey were compiled in tabular form and subjected to statistical analysis.