Sharp Thinking: A New Angle on Clinical Trial Management Systems

Life Sciences, Clinical Trials, Pharmaceutical, Medical Device,
  • Monday, March 16, 2020

New technologies are inevitably heralded as making life simpler: streamlining tasks, eliminating steps, managing things so you don’t have to manage them. Yet the practical application of a new technology often seems to make things more complex.

Clinical trial management is a case in point. Contract Research Organizations (CROs) and sponsors are juggling increased data volume, increased data variety and the demands of risk-based monitoring, all in service of risk-based quality management (RBQM). Even though technology generates critical reports, calculating results and organizing facts, the reports themselves are often static. Someone still wrestles with the task of manually piecing together files and trial data.

These strategies are rooted in legacy methods and old thinking from the days when trial data was predominantly captured on paper. Why are software and services companies still trying to sell CROs and sponsors technology that requires manual engagement of any sort as an upgrade?

Across every industry, new technologies invite—and demand—fresh approaches to the task itself. Google Maps eliminates the need to manage paper maps, navigating between pages when you moved from one town or state to another; Waze takes that a step further by integrating information previously available only to those with CB radios. Clinical trial management software is no different. It should not simply move the same steps you took before into an online platform. It should revolutionize the steps themselves, to deliver on the promise of simplification and speed.

This webinar will explore how to think about the technological challenge from a new angle—which may even spur CROs and sponsors to rethink the technology partners they engage with.


Joe Goodgame, Co-Founder and Chief Technology Officer, Remarque Systems

Joseph Goodgame is the founder and CTO of Remarque Systems. Joe has worked extensively in the data and information space for over 20 years and passionately believes in technology’s potential as an enabler for business needs. He has been recognized in Computer World for his cutting-edge work with building a patient analysis framework across more than 60 million patients and has been named on a number of patent applications for new and novel analysis methods.

Joe has worked in multiple industries and all aspects of data and product development with more than 16 years of experience in the life sciences. He started his career in the United Kingdom government before making the switch to industry, including developing geospatial mapping systems for utility companies and fraud detection systems in telecoms.

Message Presenter
Amanda Coogan, Remarque Systems

Amanda Coogan, Risk-Based Monitoring Senior Product Manager, Remarque Systems

Amanda Coogan worked for 12 years at university hospitals and medical device firms supporting domestic and international studies across a range of disease states, then transitioned to the software industry. There, she serves as a consultant, subject matter expert and project manager to small and large pharma, medical device and CRO customers supporting the implementation of quality risk management and risk-based monitoring. In addition to working with customers, she provides RBQM and clinical trial operation expertise to support software product development.  

Message Presenter

Who Should Attend?

This webinar will appeal to managers and above at small-to-large pharma/medical device companies and CROs with job functions including but not limited to:

  • Clinical Operations
  • Data Management
  • Medical Affairs
  • Regulatory Affairs
  • Quality Assurance
  • Quality Management

What You Will Learn

Attendees will learn about: 

  • The problem with choosing traditional business intelligence methodologies for quality management and risk-based monitoring
  • Why risk-based monitoring tools are not add-ons to existing tools but a means of consolidating capabilities
  • How to consolidate and operationalize systems and business intelligence tools

Xtalks Partner


Remarque Systems is a provider of solutions for risk-based monitoring, in-process analytics, and continuous development for data quality improvement. Headquartered in Raleigh, N.C., with a development center in Indianapolis, Remarque Systems has developed the first fully integrated workflow system to design, deploy, and manage clinical trials. For more information about the Remarque Systems Platform, please visit the company’s website at or email mailto:[email protected]. Also, follow Remarque on LinkedIn and on Twitter @RemarqueSystems.

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