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SOP Review for a Clinical-Stage Biopharmaceutical Company


Since the release of ICH (E6) R2 in 2017, clinical research companies have been taking active measures to ensure compliance with its new guidance which, “encourages implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting while continuing to ensure human subject protection and reliability of trial results.”

In 2018, a clinical-stage biopharmaceutical company requested that Avoca perform a thorough review of its policies, procedures, work instructions, forms, and templates against the expectations outlined in ICH E6 (R2) and other relevant industry-leading practices.

Because the company was a member of the Avoca Quality Consortium (AQC), Avoca’s project team leveraged AQC leading practices, where applicable.

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