How One Clinical Operations Team Returned 100% of Studies to Within Risk Threshold: A Next Gen Monitoring Case Study

Life Sciences, Clinical Trials, Pharmaceutical,
  • Thursday, May 26, 2016

In a recent survey of 300 global CinOps leaders, the majority agree that risk-based monitoring is a top priority, yet only 8% indicated that they have successfully automated their RBM program.

Without automation, RBM initiatives have been proven difficult to implement effectively.

This case study details how one successful ClinOps team automated their risk-based monitoring program. After only 10 weeks, they were continuously and efficiently optimizing Key Risk Indicators across enrollment, compliance, site productivity to lower risk and increase speed to a quality result.


Ken Wu, ClinOps Consultant and Expert

Kenneth Wu has been a ClinOps consultant for ten years. His clients have included large global Pharmaceutical companies, biotechnology startups, medical device companies, and contract research organizations (CROs). Through a long career in Clinical Operations, Ken developed expertise in clinical process optimization with LEAN Six Sigma, clinical operations analytics, and operational forecasting.

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Matt McKinney, Continuous Quality Solution Expert, Comprehend Systems

Matt McKinney is currently a Sr. Sales Engineer with Comprehend Systems and was one of the early employees with the company. In his current role with Comprehend, Matt is charged with evangelizing the Comprehend solution to new and existing customers by delivering product demonstrations, leading workshops and working closely with customers to help get them trained and onboarded with Comprehend. Prior to Comprehend Matt spent seven years with Medidata Solutions as a Sr. Business Consultant helping grow Medidata from a small start up to a 3 billion dollar company. Matt has deep eClinical Industry experience and has a passion for helping customers enable cutting edge technology to help with the enablement of bringing safe and effective treatments to market to serve the patients who need them the most. As the husband of a breast cancer survivor Matt has a deep sense of purpose when it comes to working with customers who are trying to bring Oncology therapies to market. Matt holds a bachelor’s degree from the University of Texas at Austin and is a certified PMP (Project Management Professional) from the Project Management Institute.

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Who Should Attend?

Clinical Operations and Data Management Professionals

  • Clinical Trial/Clinical Study Management
  • Clinical Data/Informatics/IT
  • Clinical Outsourcing

Clinical Research, Technology and Business Professionals

  • Biometrics/Biostatistics
  • Business Technology/Applications/Solutions
  • Business Analyst
  • CTO
  • Project Management

Medical and Scientific Professionals

  • Chief Medical Officer
  • Chief Science Officer
  • Compliance
  • Drug Safety/Pharmacovigilance
  • Quality Assurance
  • Regulatory Affairs

Xtalks Partner


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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