Information Systems in Clinical Trials: Pragmatic Validation of EDC Systems

August 18, 2020
Elsevier

Sponsored Content

Join us as we explore system validation with Will Crocombe from RISG Consulting, and share practical ways to address change overload and survive a visit from the inspectors. Live: Thursday, Sept. 17, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST On demand available after airing until Sept. 17, 2021.

Register free: https://www.appliedclinicaltrialsonline.com/act_s/edc_systems

Event Overview:

Computer System Validation is a key regulatory requirement and one which challenges the understanding and resources of many research organizations. Achieving the validated state means managing an ever-changing environment of servers, operating systems, EDC software, security patches etc, some or all of which may be outside the direct control of the organization. And all this needs considering before you have even started developing your study database.

GCP expects a risk-proportionate approach, but how can this be approached, pragmatically?

During this webcast we’ll explore the scope of EDC system validation and offer practical ways of dealing with change overload and surviving a visit from the inspectors.

Key Learning Objectives:

Join us for this webcast to:

  • Understand the scope of system validation and the challenges this brings
  • Discover an approach to unpicking the complexity
  • Have an opportunity to discuss practical solutions

Speakers: Will Crocombe, Director, RISG Consulting, UK

Oli Cram, Macro General Manager, Elsevier

Time and date: Thursday, Sept. 17, 2020 at 11am EDT| 8am PDT| 4pm BST| 5pm CEST

On demand available after airing until Sept. 17, 2021.

Sponsor: Elsevier

Register free: https://www.appliedclinicaltrialsonline.com/act_s/edc_systems

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