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Next Generation Centralized and Risk Monitoring

WEBINAR DETAILS

Date: January 28, 2016

Featured Speakers:
  • Ken Wu, former Clinical Operations Executive at Scios
  • Jud Gardner, CTO & Co-Founder, Comprehend

Join this webinar to learn how a leading Clinical Operations team gave new meaning to centralized monitoring.

The presenter will show how Clinical Operations Executives, Program Leaders, Study Managers and CRAs use a single system with powerful data aggregation, monitoring, collaboration and analytic capabilities to actively manage enrollment, patient safety and site compliance processes.

Next Gen Centralized Monitoring teams continuously monitor their studies in real-time, do more with less resource to increase their speed to quality results:

  • Program Managers focus 80% of their time on the key outliers in the 20% of studies with highest risk of missing milestones
  • Study Managers drill down on daily scorecards from the study to site level, easily see outliers and quickly find root cause of issues
  • CRAs increased the average number of sites managed while reducing their visit frequency

Clinical Operations Executives, Study Managers, CRAs and their CROs can now focus on what matters and act faster.

The net result: Elimination of study overruns, achievement of on-time milestones, while returning all sites within the proper risk threshold

Keywords: Centralized Monitoring, Clinical Operations

 

ABOUT OUR SPEAKERS

Ken Wu, former Clinical Operations Executive at Scios


Ken has been consulting in clinical operations for over ten years, and has been working in clinical operations at medical device and biopharmaceutical companies for over twenty years. In clinical operations leadership roles, he has led clinical study teams in start-up device companies and large global biopharmaceutical companies, on pivotal studies to support regulatory submission. Ken’s areas of specialization are in optimizing processes and leading study teams to exceed trial benchmarks and prior expectations. His consulting expertise include LEAN Six Sigma, operational analytics, project management leadership and predictive forecasting. He has presented case studies in clinical trial management seminars, workshops and conferences. Ken has BA degrees in Physiology and Psychology, MS in Physiology and MBA with focus in operations. His roles have ranged from CRA to clinical operations department head, at companies from early innovative start-ups to global pharmaceutical companies.

Jud Gardner, CTO & Co-Founder, Comprehend


Jud is responsible for the overall product and technical direction of Comprehend Systems’ products.

Prior to Comprehend Systems, Jud was the Chief Technology Officer of an online industrial electronics distributor, where he designed and delivered software systems involving large datasets with complex, multi-tier interactions. Implementation of these systems spanned end-user data presentation down to micro-controller programming for data acquisition. Prior to that, as a consultant, Jud successfully executed difficult projects within the pharmaceutical industry, including the integration of multiple EDC systems to facilitate reporting.

THIS PROGRAM IS INTENDED FOR

Clinical Operations Teams

  • VP of Clinical Operations
  • Clinical Trial Manager
  • Clinical Research Associate
  • Clinical Data Manager
  • Director of IT, Clinical Systems
  • Clinical Systems Specialist
  • Manager, Clinical Development
  • Business Strategy and Planning Director
  • Functional Manager, Clinical Operations
OUR XTALKS PARTNER FOR THIS EVENT

comprehend
 

Comprehend is a technology company with a new class of cloud software to help Clinical Operations continuously improve the quality and speed across a portfolio of clinical trials. Comprehend Continuous Quality Solution for ClinOps eliminates quality uncertainty with powerful capabilities to unify and analyze quality data with real-time alerts and collaboration to help teams work better together. Comprehend help ClinOps see everything, focus on what matters and act faster. Comprehend is particularly effective for CRO oversight, centralized monitoring and study quality metrics. Comprehend: the speed to quality results.

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