A good RBM Command Center is the heart of a clinical trial. It pumps the most important (risk-relevant) information among the team members. In order to develop a good RBM Command Center many iterations must be undertaken. Many errors have to be made. Moreover, it does not make a difference how much working force is involved. For some activities, time is vital. As Warren Buffett once said:
“You can’t produce a baby in one month by getting nine women pregnant.”
By taking the “make or buy” decision concerning the RBM technology, it is essential that one chooses the most proven and validated technology. Immature one only adds additional overhead in the project without de-rising it.
Using a well-designed RBM command center a CRA can monitor the most important risk indicators. Additionally, performance and data quality indicators are captured and organized.
Compared to a manual approach an RBM control center offers a number of advantages, such as:
- Controls and improves data integrity automatically
- Decreases data defects
- Categorizes sites according to their performance, risks and data quality
- Presents the risk distribution and offers an agile environment that analyzes root causes and mitigates risks
- Increases transparency of decisions
- Offers infrastructure that eliminates issues quickly and efficiently
- Centralizes and audits all risk-relevant information in one place
Holistic Approach in RBM Technology
The distinctive characteristics of a holistic approach in technological solution are:
- The configurable application of algorithms at user-defined levels of study (region, country, site)
- A sponsor and project level library of analytical algorithms
- Trial-specific weights and thresholds (static and dynamic), applied to the overall algorithm
- Weights and thresholds can be adjusted for each risk or performance indicator
- An evaluated probability (of occurrence) and risk impact based on retrospective data
- The tiered application of user-defined variables (weights, probability, etc.)
- A user-friendly interface
Reporting and Visualization
An important aspect of a data-driven RBM is the interface a CRA uses to obtain risk-relevant information. A well-designed RBM visualization engine provides:
- A drill-down capability to review and analyze risk relevant information
- The ability to categorize sites as low-risk, mid-risk and high-risk
- The ability to produce graphical presentations of its analyses
- Filters by subset within various analytical presentations
- The generation of CSV-, Excel, or PDF-based reports
- A customizable set of risk indicator algorithms, as needed for each unique protocol
- Seamless working with third-party recording systems (e.g., Medidata Rave, ERT’s ExpERT, etc.)
- The functionality to send and receive relevant information, such as alerts and recommended actions to CRAs, sites and the project management team
- A streamlined process for a root-cause analysis
- The re-usability of essential or standard sets of analytics across trials
- Inter-trial comparison based on standardized metrics
- The creation of trial-specific visualizations and analytics
Each clinical trial is unique in its design, purpose, objectives and outcomes, and, therefore, careful attitude towards the choice of the RBM solution is important.
Consideration and planning must happen before implementing cost-reduction measures in the monitoring activities. Moreover, the cost should not be the main motivator of the RBM in the first two-three projects. Measurement of integrity, quality and accuracy of the data should stay in the first place. No cost savings are worth compromised results.
Summing up, Cyntegrity advises in make-or-buy decision concerning the RBM technology strongly consider outsourcing option; Value more improvements in data quality and integrity instead of cost factor; Find the most suitable and experienced external/internal team for your first pilot trial.
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