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As biopharmaceutical sponsors search for the optimal approach to targeted monitoring and reduced Source Data Verification (SDV), CluePoints introduces an Intelligent Statistical approach like no other.

However, help is at hand in the form of regulatory guidance that advises that the outdated and costly approach to on-site monitoring and Source Data Verification should be significantly improved by employing a centralized risk-based approach.

Drive Risk Based Monitoring Strategies

The FDA admits that the traditional on-site monitoring visit schedule of four to eight-week intervals, with 100% source data verification is based on industry’s perception that is the FDA’s "preferred way for sponsors to meet their monitoring obligations."

CluePoints can be deployed as the engine to drive Risk Based Monitoring based on Central Statistical techniques. This approach complements efforts to identify Key Risk Indicators (KRIs) although they are significantly different concepts, SMART processes all elements of the clinical data in a comprehensive manner, with no predetermination of risk.

This results in an objective view of which sites exhibit outlying or discrepant data and, hence, allow on-site monitoring activities to be targeted to address those centers as a priority.

The large number of statistical tests employed to analyze all elements of the clinical data result in a scoring that, individually, wouldn’t necessarily have a significant impact on the assessment of site risk.

However, when these assessments are aggregated together, with no distributional assumptions, they are able to detect issues in the data set that are difficult and costly to find using traditional monitoring and Source Data Verification. Eventually, each site is assigned a score, from the most dissimilar site to the most normal one.

An example of the graphical content of the report follows:

How does it work?

For over a decade, our dedicated team of statistical experts has been developing a powerful engine known as SMART , a patent-pending software solution that will allow you to assess the quality and integrity of your clinical trial data.

The elegance of this solution lies in its simple and pragmatic approach to enhancing efficiency in the monitoring process:

• You give us your trial data set periodically throughout your trial.
• At the outset, we will determine the appropriate statistical techniques to use based on our propriety set of highly-tuned algorithms and then run your data set through the SMART engine.
• We will then interrogate the resulting output and provide a report that identifies all the signals that highlight anomalous and inconsistent site data and why they could have occurred.
• We will work together to determine how best to target ongoing monitoring activity and Source Data Verification based on these results.
• You will enhance patient safety, cleanse and improve site results throughout your trial and, ultimately, reduce regulatory submission risk by providing the best quality data set based on the objective analysis and interpretation of information

Optimize On-site Monitoring and Reduce Cost

"The vast majority (84%) of sponsor companies report that they are checking 100 percent of their source data against case report form data." Kenneth A. Getz MBA, Senior Research Fellow at the Tufts CSDD; "Low Hanging Fruit in the Fight Against Inefficiency", Applied Clinical Trials.

This comprehensive on-site monitoring and 100% SDV is acknowledged to represent over one-third of the entire Phase III pivotal trial budget and each monitoring site visit costs Biopharma sponsors in excess of $5,000 per visit. A Tufts study found that using a risk-based approach to reduce the number of monitoring visits and data points verified would save sponsors between $3- $5 billion each year.

Even with the most conservative of savings estimates, a 10% reduction in monitoring expenses, driven by targeted SDV using CluePoints, will result in hundreds of thousands of dollar savings with the potential for much more.