Section 5

The Next Frontier of RBM

Category 1: Management of Technology Solutions

Category 2: Integrating Change Management

Category 3: Managing Guidance and Requirements from Health Authorities

Category 4: Identifying the Right Metrics

GLOSSARY: Key Terms Defined

Category 1: Management of Technology Solutions

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Sponsor companies implementing TransCelerate’s RBM methodology have observed that success of RBM is predicated on a combination of the right people, processes and technology. Since RBM technology is still relatively new and rapidly changing, successful technology solutions will likely adapt and evolve to meet the needs for future clinical trial environments. In other words, it’s important for the players enacting RBM plans to consider what technology products can offer right now, as well as what they can offer in the long-term.

Moreover, cost-benefit considerations of new technologies will undoubtedly affect companies’ evaluations of new solutions that will enable efficient delivery of the right information to the right person.

Right now, RBM relies on technology to support activities related to:

Ideally, optimal RBM systems in the future will excel at each of these areas. But as the needs around these activities evolve, companies will need to support scalable implementation. Therefore, multiple technologies may be needed now and in the near future to achieve a holistic system solution. This means that it will be important for RBM systems to be able to integrate with independent systems that complement it.

What are some capabilities and processes that may change due to new technology?

Click on each category below to learn about capabilities and processes that might change with technology; then scroll over the sub-categories to uncover more.

New Technology

Data Lineage

Trace data points

Future technology systems may be able to trace each data point from its origin through data integration and to the user interface.

Reveal major point of persistence

Lineage can reveal each major point of persistence and any transformation, deviation, aggregation or harmonization that occurs with the data.

Close tracking of data's journey

Close tracking of the data’s journey could support multiple elements of an RBM plan; for example, it can help users follow the data back to the original source when responding to a Risk Indicator exceeding a Threshold.

Risk Indicators

New Technology

New technology may allow for a deeper understanding of existing Risk Indicators.

Discovery of new risk Indicators

Systems that enable users to uncover useful patterns, trends and outliers may lead to the identification of new Risk Indicators as well as appropriate Thresholds to associate them with.

Risk Level Adjustment

Integration of new processes & systems

The integration of new processes and systems – like statistical monitoring – may improve efficient risk level adjustment, providing potential responses to changing risk levels over the course of the study.

Audit Trials


It will be important for a pattern of technology capabilities to evolve that more closely align with regulations and requirements.


All transactions will be tracked so that a record can be retrieved to show the state of data at any given point in time.

As RBM continues to evolve, and as the industry more widely recognizes and adopts proactive risk assessment, technological support will also almost certainly evolve.

Section 5: The Next Frontier of RBM

Category 2: Integrating Change Management