“Historically, we always looked at monitoring as something you had to do on a routine interval for any program. And it’s extremely costly. Yet it’s known that the increased frequency in monitoring doesn’t necessarily deliver better quality.” Mitchell Katz, PhD, Executive Director, Medical Research Operations, Purdue Pharma; “Can Trial Monitoring Be Changed?”, Applied Clinical Trials
The vast majority (84%) of sponsor companies report that they are checking 100 percent of their source data against case report form data. This traditional approach is maintained by sponsors as regulatory pressures are perceived to dictate this approach. However, regulatory agencies themselves advise that this outdated concept is overkill, unnecessary and may not produce the data quality expected. Adding the cost and resource burden, resulting in one-third of the total Phase III trial budget being spent on field-based monitoring and SDV, you are left with a hugely inefficient and costly process which doesn’t necessarily produce the required results.
CluePoints® is able to drive intelligent on-site monitoring strategies that will result in significant cost and resource savings whilst improving the quality and integrity of data and reducing regulatory submission risk.
“CRO’s are always looking to improve their operating margins and this [Risk-based Monitoring approach] may afford some downsizing of study monitoring infrastructure. If a data collection risk is introduced that requires further investigation, I imagine that CROs will look to primarily use existing resources to perform that examination.” Kenneth A. Getz MBA, Senior Research Fellow at the Tufts CSDD; Applied Clinical Trials
As sponsors explore Risk-based Monitoring strategies to optimize on-site monitoring activities and reduce costs, this approach can be used by CROs to lower their own operating costs. Using CluePoints®, you are able to comply with regulatory guidance but provide fewer resources to the sponsor since traditional on-site monitoring and 100% source data verification is no longer necessary.
“Sponsors contend that there is no evidence to support whether 100 percent SDV improves data quality. A recent Society for Clinical Data Management report noted that SDV is an intensely detailed task that is prone to human error and inaccuracies.” Kenneth A. Getz MBA, Senior Research Fellow at the Tufts CSDD; Applied Clinical Trials
CluePoints® is committed to improving the quality and integrity of clinical trial data whilst reducing regulatory submission risk and optimizing process efficiency. The organization is borne out of decades of academic work into the examination of fraudulent clinical trial activity and identification of anomalous data patterns, resulting in the improvement of clinical research results.
Consequently, CluePoints® collaborates with a number of academic institutions to assist in driving efficient targeted monitoring / SDV activities and improving data quality. We encourage academic institutions to contact us to further government and academic research and take advantage of the power of these Intelligent Statistical Monitoring solutions.