ICH E6 (R2) requires sponsors to maintain responsibility for oversight of vendors, including those handling your clinical trial data. This often is challenging, particularly for companies with limited or no biometrics departments internally. Correct and effective data oversight increases your confidence in your clinical trial results and supports progress of development programs. During this webinar, we will review the components of biometrics oversight, assess various approaches, suggest an effective data oversight strategy and present case studies. The key learning outcomes will be:

• Understanding of the importance of oversight for clinical trial data

• How to choose the right approach to data oversight

• What are the fundamental components of an oversight program

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Software is present at all levels, at the interface with low level hardware though to the interface with end users, and everything in between.
But the nature of software raises many issues concerning its management, protection and exploitation. This is due to the range of different application areas; its ability to operate globally; its fast rate of development, adaptation and change; and its composite nature. Because we also live in an interconnected world, software needs to manage its interfaces, and to take into consideration formal and de-facto standards, to ensure seamless interoperability.

This webinar will look at some specific issues concerning the protection and exploitation of software, such as the most appropriate IP Rights to use (e.g. patents, database rights, etc), and different exploitation models for design tools, product and services (e.g. Open Source licensing, start-ups, etc).
This webinar is relevant for all those involved with developing and exploiting software tools, products and services; or acquiring or licensing it in; whether they are SMEs, large companies or researchers.

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