SOURCE: Xtalks

Xtalks Webinars

September 02, 2015 07:00 ET

Data Monitoring Committees: Simple Solutions for Critical Issues, New Webinar Hosted by Xtalks

TORONTO, ON--(Marketwired - September 02, 2015) - The key topics for this webinar are setup and communication for data monitoring committees. The featured speakers for this one hour presentation includes Angela McPartlane, Associate Director of the DMC Unit at PRA Health Sciences, and Andrew Mitchell, Director of Life Sciences Strategy and Product Marketing at Intralinks. The live broadcast takes place on Friday, September 25, 2015 at 11am EDT / 4pm BST (UK GMT +1).

The use of Data Monitoring Committees (DMCs) is becoming increasingly common in drug development and while they have clear benefits, poor set up and ill-defined communication pathways can cause irreversible problems for a drug development program.

This webinar will focus on two important aspects of Data Monitoring Committees:

1. Data Monitoring Committee Set-Up

  • DMC set-up can often be a secondary consideration given the environment of compressed timeframes and emphasis on regulatory approvals and site activation. But because of the importance of the DMC and its potential impact on a study, it is essential that the appropriate DMC members (voting and non-voting) are identified and the operating characteristics are discussed and agreed upon during the startup phase of a study.
  • With DMCs typically unblinded during ongoing study conduct, most of the documentation for DMCs is highly confidential and market-sensitive. Therefore it is critical that the necessary 'firewalls' are in place and all access to unblinded (closed) documentation is well controlled and easily auditable. In addition, all other DMC content can be managed in a secure, controlled manner.

2. Data Monitoring Committee Communication

  • The highly confidential nature of DMC reports and decisions requires a communication solution that is highly secure and enables different levels of access based on specific roles.
  • In order to be easily adopted and fully utilized, a DMC communication solution must not only be regulatory compliant and secure, but also user-friendly, simple to use and able to handle large files.

Learning objectives of the webinar

  • DMC members will learn about approaches and solutions that will ensure an effective DMC set-up as well as an easy-to-use method for data exchange and documentation.
  • Sponsors or staff at Data Analysis Centers will learn about approaches and solutions that will facilitate the timely set up of DMCs and provide assurances of the secure and controlled dissemination and access to DMC documentation.

To learn more about this event visit: Data Monitoring Committees: Simple Solutions for Critical Issues

Xtalks, powered by Honeycomb Worldwide Inc., is a leading provider of educational webinars to the global Life Sciences community. Every year thousands of industry practitioners (from pharmaceutical & biotech companies, private & academic research institutions, healthcare centers, etc.) turn to Xtalks for access to quality content. Xtalks helps Life Science professionals stay current with industry developments, trends and regulations. Xtalks webinars also provide perspectives on key issues from top industry thought leaders and service providers.

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