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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

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.

There is increasing recognition of the importance of implementing risk-based monitoring (RBM) systems to aid with the monitoring and reporting of relevant risks in clinical trials, rather than relying on traditional methods based on disparate data sources and manual collation processes.

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Bioclinica is organized into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging & Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Molecular Marker Laboratory. Our eHealth segment comprises eClinical Solutions, Randomization & Trial Supply Management, Safety & Regulatory Solutions, and Financial Lifecycle Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

RT @eClinical_Jen: FREE on-demand webinars from @bioclinica on EDC, Imaging, RBM, and Clinical Trial Management. Tell them I sent you! http…
bioclinica (14 hours ago)
Excited to host NJ Lt. Gov. Kim Guadagno, clients, partners 9/28 in Princeton! In the area? Join us ! RSVP… https://t.co/PrfyxvasGb
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Be sure to follow #ThankAScientist all week to thank researchers for the work they do! https://t.co/Sfi9mmHbSk… https://t.co/y9ZhBXsIzu
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Cardiovascular imaging use is growing in non-cardiovascular areas #ClinicalTrials. See where in Tim Crowe's blog… https://t.co/dYjPBC0Wtn
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RT @Xtalks: Cardiovascular Safety in #Biopharmaceutical Product Development - From QT Prolongation and Beyond @bioclinica https://t.co/mCk1…
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RT @Xtalks: How Innovations in Data Visualization Are Accelerating Data Cleaning and Improving Quality @bioclinica https://t.co/vfLU8pS9Rd
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