Webinar on Advanced EDC Trials: The Team is Working Together, Now Get Ready for Change

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Xtalks presents a live webinar on September 10, 2012 at 1:00pm EDT on Advanced EDC Trials. Join our keynote speaker, St. Clare Chung, Director, Biostatistics & CDM, SCiAN Services Inc., for this third webinar in our series examining the impact of one or more protocol amendment(s) on the study database and the EDC team and how changes can be implemented smoothly and with minimal effect on the ongoing study. Register for the webinar at http://xtks.in/xto-503.

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At this stage of the clinical trial, the Sponsor has initiated sites, patients are being screened, enrolled, randomized and treated. The CTM and CDM group are completing their tasks smoothly. When things are running smoothly, no thoughts are given to fine tuning the system to how users interpret the protocol or how the system is used across different sites.

Then comes the dreaded protocol amendment which may change everything that has been established: (i) inclusion/exclusion criteria, (ii) study assessments, (iii) treatment group assignment, (iv) interim analyses, to name a few.

Topics covered include:

  • Typical protocol amendments and their impact on the study
  • What and how the eClinical system can implement the changes
  • What the EDC team needs to know and how they should be informed
  • Timing the changes/deployment
  • Monitoring the effect of the changes/deployment and finetuning

What you will learn:

  • How to assess the risk/impact of one or more protocol amendments and the

feasibility of pre-planning

  • How to develop a deployment plan
  • How to deploy protocol amendments through an EDC system to ensure data

consistency across all sites/subjects

  • What you need to pay attention to after each protocol amendment is rolled out

For more information or to register go to http://xtks.in/xto-503.

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 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.

To learn more about Xtalks visit http://xtalks.com/ContactUs.ashx

Karen Lim (416) 977-6555 ext 227

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