If a CRO is Managing My Clinical Trial Data, What are My Validation Responsibilities?

If you have a Contract Research Organization (CRO) that is managing and hosting your content and you're accessing their content management solution, the responsibility is on the CRO to have a validated compliance content management solution for your content. However, you have to do due diligence and close your vendor auditing practices, your vendor management processes, and your SLA with your CRO to ensure that you've done proper due diligence to make sure that they are properly managing your content. The burden is effectively on the CRO, however you have to do your due diligence to ensure that you're auditing them appropriately out of their system validation materials, as well as making sure that the processes and procedures are up to par for managing content.

The USDM Life Sciences Clinical Services and Solutions team provides our clients (from start-up Biotech to large Pharma/Device) with the latest technology, processes and strategies to assist with efficiency, quality and compliance in any scenario and offers our clients a cost-effective, proactive and unified partnership in goal achievement.