SMB Validation

How do you recommend handling CROs and vendors in a timely basis?

The data that a CRO generates is ultimately the responsibility of the company that hires the CRO to do the research. That company must be on top of the CRO, their record keeping practices and their adherence to GxP. If a CRO is sending results back to the study sponsor, a compliant, secure, closed system is best to use. Just like with vendors, it is wise to audit the CROs and the vendors to make sure that they are up on their Part 11 (and GxP compliance).