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 In 2018, a clinical-stage biopharmaceutical company requested that The Avoca Group 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. To download the White Paper, complete the form. |
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