Home
Up
The 'Regs'

Clinical Trial Compliance Services

Click here if you would like to see what can happen when Good Clinical Practices are not implemented in your organization.  Good Clinical Practices are not just good for supporting your product registration, in the USA they are required by regulation 21 CFR 812.

We offer monitoring services complying with USA, European, and International Good Clinical Practice regulations, standards, and guidance.  Our seasoned auditors not only interview the CRAs and assess the data for compliance, but feedback essential technical and practical information to the client about the conduct of the trial and issues along the registration pathway.  Monitoring, and independent auditing ensures consistently reliable and usable data to support submissions for registration, advertising claims, and or acquisition of government reimbursement.   Our monitors work according to CRO Group standard operating procedures or the client’s procedures.

Often as a result of audits, we support our clients with tailored standard operating procedures for the sponsor, investigator, and the CRAs so that the audits result in a compliance finding.  Medical device companies wishing to run a collateral European or Canadian trial often turn to CRO Group for standard operating procedures which ensure compliance with all regulations, standards, and guidance.

Copyright © 1996 - 2005 The CRO Group Inc.   All rights reserved.