Creating Approaches for Quality Assessment for Clinical Research Cro's

ISBN-13: 9786203926989 / Angielski / Miękka / 92 str.

Ramesh c; Swetha Ramesh

Opis

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.

O autorze

c, Ramesh Dr. C Ramesh is a highly accomplished professional with 25+ years of rich experience in Teaching, Learning & Training Development, Clinical Research & QA, QC, and Project Management. He has made significant contributions towards drug research and conducted many training programs for professionals to understand more about clinical trials.