A team of experts propose Risk-Based Monitoring (RBM) services that match the characteristics of the study, utilizing a variety of methods, procedures, and tools.
By combining the identification of important process data and risks, the timely share of information obtained through data visualization, and the optimal monitoring activities according to the trial characteristics and monitoring system, our specialists can minimize possible risks and achieve an efficient operation.
Provision of Optimal Clinical Monitoring Strategies
The purpose and design of the studies vary widely.
With the rapid development of Decentralized Clinical Trials (DCT), it is very important to consider the monitoring strategy, including the use of central Monitoring. Our RBM service focuses on the data and processes that are important for each study, proposing and providing the best monitoring strategy to achieve the study`s objectives.
Our team consists of staff with extensive knowledge and experience in clinical monitoring, data management, and statistical analysis. By unifying perspectives on risk management and deciding on study implementation policies and methods prior to the study launch, we can ensure efficient and high-quality study execution.
We provide optimal services for each study by utilizing various systems (data visualization, statistical monitoring, and tools for setting up Partial SDV items) necessary for RBM execution
- Identification of important data/processes
- Study risks evaluation and mitigation strategy
- Sites risks evaluation and mitigation strategy
- KRIS and QTLs configuration
- RBM planning (monitoring strategy)
- Study risks evaluation and mitigation strategies on sites
- Data review
- All fields/Subjects level confirmation
- Change of monitoring intensity
- Predicted risks review (KRIS/QTLs)
- Unpredicted risks review
- Missing data, inconsistencies, outliers, unexpected fluctuations
- Systematic abnormalities such as data consistency and integrity (Central statistical monitoring)
- SOP creation support
- Support creating risk assessment document templates (RACT, etc.) unique to your company
- Support for identification, assessment, control, review and reporting of risks related to RBM
- Clinical Trials Risk Management and RBM Planning
- Identifying Critical Processes and Clinical Data
- Identification and evaluation of risks
- Risk prevention and mitigation measures strategy and identification of implementing departments
- QTL configuration
- Application of risk preventive and mitigation strategies to various operation procedures and operation plans
- Formulation of RBM planning (monitoring strategy)
- Evaluation of risks on sites during feasibility study
- Data review planning per item/patient
- Change monitoring intensity (SDV/SDR change)
- Central Monitoring
- KRI settings
- RBM related system configuration
- Periodic signal analysis/evaluation of pre-defined KRI and QTL, and issuance of alerts
- Centralized Statistical Monitoring
- Action instructions for monitoring services