Contract for the provision of External Audit of BCGcattle Phase 3

Description

Contract for the provision of External Audit of BCGcattle Phase 3 Lot 1: The requirement is for the external auditor to be based on the extended field work to complete Phase 3. The complexity and challenges around this project are numerous and the external auditor brings stability and experience. The external auditor is critical to success of the field trials.<br/>​Defra have invested in the development of a vaccine and companion DIVA test for bovine TB and it is expected that these will be a key tool in the control of this disease. For granting of a Marketing Authorisation (MA) by VMD a field trial of both diagnostics demonstrating safety and specificity must be run in the field. The external auditor will ensure that the field trial complies with GCPvet by performing audits as well as providing consultancy as and when required. Any significant deviation from GCPvet would risk granting of the MAs, and the field trial having to be repeated.