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.

Keywords:

Speakers

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.

Message Presenter

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.

Message Presenter

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

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.