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New ICH GCP Guidelines Implementation (including RBM and quality management): What do you need to know from your CRO?
By Penny Manasco - February 22, 2017
Late last year the ICH finalized its new guidelines for GCP. These guidelines differed significantly from previous versions and should affect how you evaluate CROs’ performance in these areas.
To help Sponsors better evaluate compliance with new GCP requirements (expected to be implemented in Mid 2017), Applied Clinical Trials recently published a paper, Does your CRO comply with ICH E6?, authored by Penelope Manasco, M.D., CEO of MANA RBM. It identifies critical questions for you to ask CROs to better evaluate whether and/or the degree the CRO complies with the new changes in GCP.
This paper also provides the expected responses from the CROs to help Sponsors evaluate the answer provided versus the answer needed. If you want to learn more about evaluating CROs for complying with the new, ICH GCP Guidelines, please register for our webinar: Evaluating CROs for Compliance with new GCP Guidelines on Mar 3, 2017 2:00 PM EST at:
After registering, you will receive a confirmation email containing information about joining the webinar.