Four stages of RBM Evolution in a Pharma Company
Intelligent software systems are facilitating the data accumulation in clinical trials already. The 75% of clinical trials are conducted with the Electronic Data Capture (EDC) . The next step is to unfreeze the knowledge of the data accumulated and direct it into the actions of a team.
Linda Sullivan the CEO of Metrics Champion Consortium, writes: “electronic solutions are facilitating the flow of data and performance metrics into analytic reporting tools that help answer important questions about trial risk, study progression, and vendor and site performance.” 
Still, for each challenge – there is a need for a specialized tool.
“We do not need an XRAY to detect that somebody is in a room.“
It is essential to understand what advantages each approach has, in order to be able to select the right one.
What is clear, after the GCP addendum, is that RBM is the a necessity in clinical trials. The main question is what elements of the RBM approach should be used in what trial and in what situation?
There are four main stages of RBM evolution, which each pharma company goes through:
Let us summarize in a table the pros and cons of each of this stage:
The more pharma develops in the understanding of the risk management the more company moves from one evolutionary stage to the next.
In most of the cases, pharma companies start implementing a mixture of monitoring practices: centralized, triggered, targeted. If a centralized monitoring detects a problem in an ongoing trial, a sponsor can initiate a planned or additional on-site or off-site visit based on predefined triggers to keep a close watch on the detected problems.
“If a site was contracted to enroll 10 patients, but after three months, it has not enrolled a single patient, whereas other sites are on track, something is clearly wrong. Did the site lack the correct study population? Was the site unprepared to perform the protocol?“. In such a situation, we may need a triggered monitoring approach.
Successful RBM in a clinical trial relies largely on a correctly chosen monitoring mixture and understanding on what RBM evolution stage the pharma company or CRO is. Improper implementation could affect subject safety and data quality. It is essential to understand all the pros and cons of the existing stages and be ready to move further depending on the requirements of a trial.
 Medidata, “Capturing the Value of EDC.” [Online]. Available: https://www.mdsol.com/sites/default/files/RAVE_Capturing-Value-EDC_20131130_Medidata_White-Paper.pdf. [Accessed: 31-Mar-2017].
 Sullivan, L.B., n.d. Standardized Metrics for Better Risk Management: The Right Data at the Right Time [WWW Document]. URL http://www.appliedclinicaltrialsonline.com/standardized-metrics-better-risk-management-right-data-right-time [Accessed: 30-Mar-2017].