Webinar | May 18, 2018

Preparing Research Organizations For Digital Tools And Part 11 Compliance

Source: Quorum Review IRB

A complimentary on-demand webinar to help your organization

Is your research organization prepared to take advantage of innovative tools and technologies that are available for clinical research today?

  • eConsent
  • eCTMS
  • eReg Binders
  • ePRO
  • and more

These digital “eTools” can help you improve research efficiency and quality. But they also require additional regulatory compliance activities at the research site and knowledge of FDA computer system validation requirements. Remember, the sponsor or software vendor can help, but they cannot completely address these obligations for you.

In this complimentary webinar, you will learn the key regulatory requirements a research site must be aware of before implementing eTools, including helpful tips on how to build a risk-based compliance plan. In addition, you will hear how a leading eCTMS software vendor, Bio-Optronics, is helping sites take advantage of eTools and remain compliant with FDA Part 11 requirements.

Who should watch

VPs and Executive Directors of Clinical Research Compliance or Operations at Research Sites, Hospitals, Health Systems, Academic Medical Centers or any other research organization looking to implement technology solutions in clinical research.