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Kristin Mauri

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Kristin Mauri, PMP
Global Head, Risk-Based Monitoring

Kristin Mauri heads Bioclinica's global Risk-Based Monitoring (RBM) practice and ClearSite solution. Ms. Mauri brings more than 20 years of clinical project management experience and eClinical technology implementation for pharma, biotech and CRO organizations. Prior to joining Bioclinica, Ms. Mauri was the Director, Product Strategy at Oracle Health Sciences, where she was responsible for growing both the technology partnership program as well as leading the risk-based monitoring strategy. A recognized thought leader and industry speaker, Ms. Mauri has presented extensively on clinical trial forecasting and budgeting within the realm of emerging eClinical technology. Ms. Mauri's educational credentials include an MBA from Lake Forest Graduate School of Management, MGH Boston master's program coursework in Clinical Investigations and a bachelor's degree from Pennsylvania State University.

Blogs

Risk-based monitoring (RBM) is finally starting to gain momentum as the standard for trial execution within the industry. In fact, a few of the TransCelerate companies are already working in a model where RBM is deployed across all trials, and RBM is also finally starting to take off with mid-size to small pharma. Before long, RBM will become the de facto standard for trial execution.

Since the release of ICH E6 R2 in November 2016, we have been flooded with opportunities to attend and view webinars, seminars and blogs on the topic. While extremely educational, these industry-led learning sessions rarely provide sponsors or CROs with what you so desperately need… a practical guide to creating a roadmap to compliance.

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.

As you may already be aware, a key recommendation in the latest revision to the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH E6 R2), finalized in November 2016, is the use of a quality-based approach inclusive of risk-based monitoring (RBM). It also recommends centralized monitoring processes.

As the industry and organizations' experience with risk-based monitoring and quality management in clinical trials matures, we're seeing a shift in the type of RBM systems being used. While custom-built systems were once many sponsors' go-to solution, we're increasingly seeing the use of off-the-shelf, cloud-based software, otherwise known as Software as a Service, or SaaS.

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Successful clinical trials require the ability to see key details and uncover hidden insights. Bioclinica utilizes science and technology to bring clarity to clinical trials, helping companies to develop new life-improving therapies more efficiently and safely.

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