Insights Blog

Mary McGuire, GCP Auditor on Behalf of Polaris Consultants

Mary McGuire is a GCP Quality Assurance specialist, trainer, auditor, and project manager, authoring on behalf of Polaris Compliance Consultants. She is an R.N. with extensive clinical and pharmaceutical experience, and understands both sponsor and investigative site needs. She has over twenty years of experience in Quality Assurance.
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Q&A Follow-up from “What ICH E6(R2) Really Means for Research Sites!”

Posted by Mary McGuire, GCP Auditor on Behalf of Polaris Consultants on Nov 13, 2018 2:05:02 PM

Polaris Compliance Consultants was delighted to present Complion’s October 24th webinar, “What ICH E6(R2) Really Means for Research Sites!” Far more questions were submitted during the webinar than we could address during the Q&A period, so we would like to answer them here. It was interesting to see that most of the questions related to documentation and document retention. That can be a confusing area for study sites. We hope you find these responses helpful.

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Topics: GCP, Document Management, Compliance, Regulatory Compliance

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Complion provides clinical research sites and their sponsors with a software platform to enable secure, compliant and efficient management of documents and administrative tasks. We would love to hear from you with any questions about our Insights blog or to learn more about our software platform.

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