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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

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.

The latest International Council for Harmonisation (ICH) Good Clinical Practice (GCP) E6 addendum includes recommendations for ensuring quality management in clinical trials at the forefront.

Last week I hosted a webinar called "What Effect Does ICH E6 R2 Have on Risk-Based Monitoring and Overall Quality Risk Management?" The webinar focused on the recent revision to the ICH Guideline for Good Clinical Practice (E6 R2), which primarily addresses quality management with a focus on risk identification, evaluation, contro

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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.

[LIVE WEBINAR 7/25] Pharmacovigilance case studies. https://t.co/wlO43PAptj https://t.co/wCtpPVsS6I
bioclinica (20 minutes ago)
Welcoming our new #eHealth App xChange Partner AB Cube! Get the news via @ClinicalLeader1 #pharmacovigilance https://t.co/EMe2pNjfTD
bioclinica (20 hours ago)
Let's keep the #AAIC2017 convos going! View #Alzheimer clinical trial resources https://t.co/PGVNjLuBCP
bioclinica (20 hours ago)
"Medical record mud run" 1 obstacle in vaccine trials w elderly. Here R 5 more & how to conquer by Dr. Craig Curti… https://t.co/5rO4jURlVF
bioclinica (21 hours ago)
News: AB Cube Joins @bioclinica App xChange. Cloud safety platform a catalyst for transformative safety change https://t.co/vXnRO8YgMa
bioclinica (Yesterday)
Our Medical Imaging team is in the spotlight for a job well done! https://t.co/6DZrRNZc7D
bioclinica (Yesterday)

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