Category Archives: Events

Risk-Based Monitoring Software

Webinar: Risk-Based Monitoring Implementation – What does ICH E6 Rev2 Mean for My Company?

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With the official publication of the long awaited revision of the ICH E6 Guidelines, now is the time to take advantage of the new information to ensure appropriate consideration of risk in study design and management.

For this webinar, CluePoints is again teaming up with Paragon Solutions, to highlight the key changes in the mandate and explain how best to address these elements for successful Risk-Based Monitoring Implementation.

Expect to Learn:

  • Understanding the key ICH E6 updates related to Risk-Based Monitoring/Data Quality Oversight and their purpose
  • Understanding how Central Statistical Monitoring(CSM) and Key Risk Indicators(KRIs) will work for you
  • Critical-to-success methods for Central Statistical Monitoring and KRIs
  • Change Management – Using E6 R2 to support your organization’s transition to RBM
  • The Monitoring plan – not just for monitoring intervals anymore

When:

Tuesday, March 14th, 2017, 3:00pm GMT/ 11:00am EDT/ 08:00am PDT (Timing reflects  daylight savings time)

cluepoints_Copenhagen

CluePoints Announces Locations for Risk-Based Monitoring Implementation Roadshows

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The CluePoints and OmniComm Risk-Based Monitoring Implementation Roadshow is Coming to a City Near You!

In response to the rising complexity and cost of clinical trials, the industry is shifting towards the  adoption of Risk-Based Monitoring (RBM) approaches.  RBM promises to improve both clinical trial efficiency and data quality.  A major challenge to implementing RBM is overcoming perceived complexity and determining roles and responsibilities for all stakeholders.

Explore a day-in-the-life of a team responsible for successfully planning and executing RBM, revealing how you can lead your organization’s RBM journey.

We will review with you the growing evidence in favor of risk-based monitoring, and how to take, what on the surface appears complicated, and make it simple.

Key Takeaways

  • Understand the benefits from an integrated EDC, Targeted SDV, and centralized analytics/KRIs
  • Learn best practices for RBM study planning and execution, and key pitfalls to avoid
  • Draw a clear line of sight between study risk assessment and operational KRIs and quality oversight methods
  • Capitalize on the best use of statistics in central data review
  • Differentiate between KRIs and data quality assessment

Dates and Locations

November, 29, 2016
08:30 AM -11:30 PM
Moltke’s Palace, Dronningens Tvaergade 2, 1302, Copenhagen, Denmark

Register

November, 30, 2016
08:30 AM -12:00 PM
Intercontinental Paris Avenue Marceau, 64 Avenue Marceau, 75008, Paris, France

Register