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Kristin Mauri

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Kristin Mauri
Kristin Mauri, PMP
Senior Director Global Consulting, eHealth Solutions

Kristin Mauri heads Bioclinica's global Risk-Based Monitoring (RBM) practice and Compass 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.


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

I recently had the opportunity to attend DIA. While listening to the panelists, I realized TransCelerate companies appear to be the furthest along in their journey of risk-based monitoring (RBM), and even so, RBM is still relatively new for most of them.

App xChange adds Virtual Onsite Monitoring (VOS)

In advising and providing consulting to many different companies in recent years making a switch to risk-based monitoring (RBM) it's become apparent to me that the opportunity to improve patient safety and enhance data quality is the top reason for adoption.  Later this year when the revised ICH E6 (R2) guidance goes into effect we will have even more incentive to adopt RBM!

While Miami warmth and sunshine in February was undoubtedly a main draw for some SCOPE Summit attendees, for the risk-based monitoring set it was something more. It was about the opportunity for our diverse group of stakeholders to come together and give feedback in an area increasingly growing in importance - quality and risk management.


Leader in Clinical Trial
Management Solutions

Bioclinica is divided into three business segments so that we can provide expert service and multifaceted technologies. Our Medical Imaging and Biomarkers segment includes an Imaging Core Lab, a Cardiovascular Safety division, and a Biomarker Laboratory. Our eHealth segment comprises an eClinical Solutions Division along with Safety and Regulatory Solutions. Under the Global Clinical Research segment, we offer a network of research sites, patient recruitment, and a Post-Approval Research division.

Our #Alzheimers expert's work will B showcased at #ADPD2017 Preview here @adpdnet
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RT @ACROhealth: Where do you stand on regulating #mHealth & #Wearables in #clinicalresearch? w/ @bioclinica, @ICONplc, @INC_Research https:…
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RT @ACROhealth: ICYMI: @CCTAwareness’ Infographic on #clinicaltrials awareness for #Alzheimer’s and Parkinson’s treatments.…
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