Regulatory authorities expect to be able to review relevant documentation about the chosen systems used in a clinical trial. This expectation puts pressure on the sponsors and their representatives (CROs) to present the proper documentation upon inspection. But what is relevant? What should the sponsor or their representative have on hand and what can they expect the system supplier to deliver?

The white paper explains how Viedoc addresses inspector expectations on computerized systems used in clinical research. The paper details how Viedoc complies with clinical regulations, and how best to help you prepare for inspection by regulatory authorities.

The Viedoc Inspection Readiness Packet gives you access to all the necessary information you are expected to know about Viedoc and also advises on what additional documents you should have on hand if you should be inspected.

The white paper covers all of this, and much more, including:

  • Inspection Readiness
    • EMA CGP IWG Inspector Expectations
    • FDA Expectations
    • PDMA Expectations 
  • Viedoc Inspection Readiness Packet
    • Sourcing a system for your trial
    • Available documentation
    • Documents you produce
    • Additional documents kept by you
  • Validations to perform
  • Pitfalls to be avoided

Get ready to be prepared — read the white paper now to learn more.

Viedoc is a leader in Electronic Data Capture (EDC) on G2
Oct 11, 2023

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