Ensuring regulatory compliance is quickly becoming a primary reason to consider implementing an in-house, risk-based management/clinical trial quality management system. When sponsors outsource to a CRO, I've found that they often feel as if they are absolved of knowing exactly what is happening, ignoring the need for documented, risk-based oversight processes and procedures. However, oversight IS the sponsor's responsibility, especially given the newly revised ICH (E6 R2) guidelines, in which it clearly states that the sponsor is ultimately responsible to manage the CRO's quality performance.
Of the 20+ changes in the ICH E6 R2, three changes are especially relevant for this discussion. First, section 5.2 Contract Research Organization describes the sponsor's need to ensure oversight and implies that a risk-based approach should be used, and used consistently across studies and providers. Because inspectors will want to see documented evidence of the sponsor's oversight, manual processes might need to be evaluated and improved by sponsors in order to comply.
Second, section 5.0 Quality Management describes that the sponsor needs to have a system in place to manage quality throughout the trial. It is important to note that Quality Management (QM) and Risk-Based Monitoring (RBM) are different and separate processes. While you might outsource RBM to your CRO, QM will likely be retained by you, the sponsor. Your chosen QM system should support the identification of risks from evaluation to mitigation, communication and control & reporting. This is where technology support is going to be key to enabling compliance.
Third, a risk-based approach to QM and CRO oversight represents the theme of the revised ICH guidelines. The changes clearly have the undertone indicating that the regulators want us to leverage technology advancements to be more effective and efficient in the way we execute our trials.
In terms of oversight, the challenge increases for sponsors when more than one CRO is used to support your outsourcing needs. Typically, a standardized format for the information you need to demonstrate oversight does not exist, even within a CRO. Likely, the information you receive from your CROs comes in intervals, in different data formats and from different systems, making management extremely difficult.
The deadline to comply with these guidelines is rapidly approaching. Yet, demonstrating oversight and having a quality management system in place remain challenging for most organizations. Although technology solutions are available to help with oversight and QM, according to a recent survey conducted by the Avoca group, more than 20% of sponsors are not using technology for quality and oversight.
So, what are the technology options for QM? RBM/clinical trial QM technology is a relatively new software category in the industry and has been available as a stand-alone solution for only a few years. There is a misperception that you don't need this type of system in house when you have your CROs perform the monitoring activities. However, modern RBM systems can do more than just support RBM. They can support QM as well as oversight and can demonstrate you have taken a risk-based approach. The risk assessment process, which now must be completed at the beginning of every study, can be documented in an auditable, version-controlled system, and all quality-related actions can be shown to inspectors as part of the audit trail. You can determine the critical processes and procedures in the trial that will be used to assess risks and help decide which risk metrics are appropriate, identify mitigation strategies when risks do occur and document the actions taken throughout the trial. You can also measure and monitor a trial's quality tolerance limits, which is also a requirement of the revised guidelines. Therefore, a technology-based RBM/QM system is extremely beneficial for regulatory compliance moving forward.
Bioclinica's ClearSite product is an example of an RBM technology that can be used for QM purposes. Want to know more? Contact me at Kristin.Mauri@Bioclinica.com.