Speakers:
- Dr. Guiyu Zhao, Head of Medical Data Science, Clinical Research and Development, Hua Medicine
- Ms. Peng Ruiling, General Manager, Beijing Yipukenuo Technology Co., Ltd.
Topic: Effective clinical trial data monitoring using JMP ® Clinical: Concept, application, and collaboration between pharmaceutical companies and CROs
summary:
1. The role of JMP Clinical in clinical trial data review: powerful visualization capabilities
- Interactive graphics help review subjects’ conditions from multiple perspectives, revealing deep drug-drug and drug-disease relationships
- Helps internal data monitors and review agencies to quickly and comprehensively understand and evaluate clinical trial data
- Facilitates communication between doctors and statisticians, as well as subsequent communication between sponsors and review agencies
2. The role of JMP Clinical in clinical trial data quality monitoring: ongoing trial monitoring
- Medical/drug safety monitoring
- quality assurance
- Risk-based quality audit
- Building a data quality monitoring plan: close cooperation with partners
3. Outstanding case: medical/drug safety monitoring, such as analysis of adverse events
- Identify and deeply explore the hidden logic and trends in adverse events
- Revealing the relevant factors
- Signal detection: predicting possible occurrences and revealing potential risks
- Provide decision support for the next product development strategy
