Speakers:
- Dr. Guiyu Zhao, Hua Medicine, Head of Medical Data Science, Clinical Research and Development Department
- Ms. Peng Ruiling, General Manager, Beijing Yipu Kenuo Technology Co., Ltd.
theme: use JMP ® Clinical Effective clinical trial data monitoring: vision, application and cooperation between pharmaceutical companies and CROs
Summary:
1. The Role of JMP Clinical in Clinical Trial Data Review: Powerful Visualization Capabilities
- Interactive graphics help to review the subject's condition 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
- Facilitate 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 monitoring
- Medicine/Drug Safety Surveillance
- quality assurance
- Risk-Based Quality Monitoring
- Establishment of data quality monitoring plan: close cooperation with partners
3. Prominent Case: Medicine/Drug Safety Surveillance, e.g. Analysis of Adverse Events
- Identify and dig deep into hidden logic and trends in adverse events
- reveal the relevant factors
- Signal detection: predicting likely occurrence and revealing potential risks
- Provide decision support for the next step of product development strategy
