Our Webinars

Our Webinars

Integrated Summaries: Planning for the Unexpected & Reacting to the Unforeseen

Integrated Summaries: Planning for the Unexpected & Reacting to the Unforeseen

Date: Wednesday, October 30, 2019
Time: 11am EDT(NA) / 3pm GMT (UK) / 4pm CET
Length: 60 minutes

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The Integrated Summaries of Safety and Efficacy (ISS and ISE, respectively) represent the culmination of what may be a decade or more of work in clinical development. Even with proper planning, timely delivery of the integration is not always ensured, often due to reasons outside of one’s control. With the significant volume of work the integration requires plus the multiple inputs, there are myriad places for a breakdown to occur. This late in the clinical development lifecycle, any delay can have a significant impact on getting a drug approved and on the market.

In this free webinar, the featured speaker will discuss what happens when an integration goes off the rails and all that hard work and careful planning start to come apart. She will address types of issues one may face affecting the integration process and ways that one can react to them, and even more importantly, how one can proactively anticipate the issues and manage their impact. From failures with critical pivotal Phase III trials to time crunches and resource constraints, this webinar will delve into the tools necessary to keep the train on the track.

Presenter:

  • Nancy Fitzgerald, MS, MBA, Director, Biostatistics, Synteract


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