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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Meeting With Interested Parties On Topics Related To E-Source Data/ EDC Tools In Clinical Trials

15 June 2017
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ECF REPRESENTATIVES MEET WITH EMA GCP IWG

Representatives from the eClinical Forum participated in the meeting with inspectors and observers in London 12th June to discuss challenges and trends in Clinical Research. The work of the eClinical Forum in the areas of contractual requirements and risk-based software validation was presented…

- Industry best practices for contracting of trial-related services within today’s dynamic technology, compliance and stakeholder environment.
- Core user requirements for computer system evaluation that is already being leveraged within healthcare and research to provide standardised tools to evaluate risk and to develop risk management and mitigation strategies.

This work has been extensively referenced and is available for download from the downloads page of the website

Discussion allowed the two sides to better understand requirements, current concerns and potential solutions. Further meetings are planned.

Categories: Regulatory, Electronic Data Capture, EDC Hosting, Regulatory Expert Group (REG)

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