Since this document has only been published in the Chinese language, this article provides an english summary overview of the original text.
Author: Joan
China is moving forward to become more attractive for clinical research and market labelling approvals
China is moving forward to become more attractive for clinical research and market labelling approvals
Chinese Food and Drug Administration (CFDA) is under reorganization and investing on additional resources for a smoother process for overseeing drugs, foods, medical devices, testing and evaluation.
Chinese Health Policy and Regulatory Authorities Overview 2019 04
Trusting staff to work flexibly is key in the talent stakes
With more than 90% of Millennials saying flexible working is important to them, firms that don’t trust their staff to do so responsibly risk alienating and deterring talent.
Recruitment challenges
Approximately 20% of cancer clinical trials will never be completed, because they fail to enroll enough participants to be able to answer the research question
Solving the problem of clinical research enrolment
A Roadmap for Implementing Risk-Based Monitoring and Quality Management
Are you implementing or preparing to implement RBM and risk-based quality management approaches? Johann Prove presented at 2018 DIA a roadmap beginning with a look at pre-study risk planning, vendor selection and change management in RBM and RBQM.
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Risk-Based Monitoring as Best Practice
Centre Watch has published a recent survey which proposed RBM a “best practice” because indicates:
- A 16 percent reduction in critical and major findings in site audits;
- Seventeen percent better detection of significant deviations; and
- Forty-five percent fewer missing pages in RBM trials versus trials using traditional monitoring methods.
- Costs savings of up to 15 percent
For further information:
Risk-Based Monitoring Should Be Best Practice, ACRO Tells FDA