Sponsors that delegate clinical trial activity to contract research organizations (CROs) have a regulatory responsibility to ensure patient safety, CRO compliance with standard operating procedures, data quality, and trial integrity. Regulations require sponsors to maintain oversight throughout the course of a study – and inspectors expect to see evidence and documentation of proper study oversight.
Yet many sponsors struggle to manage their trials in an outsourced model because they lack the mechanisms to perform oversight. Manual inconsistent reports in different formats from multiple CROs are ineffective and not timely, hindering study visibility.
Veeva Vault CTMS is a modern cloud application that provides the data, documentation, and visibility to drive trial performance. From actionable insights to closed-loop issue management and protocol deviation triage, Vault CTMS enables effective study oversight in outsourced clinical trials.