Contract for the provision of External Audit of BCGcattle Phase 3

Concepts

• research services
• bcgcattle phase
• external audit
• external audit of bcgcattle phase 3
• the external auditor
• audit
• bcgcattle
• audits
• consultancy services
• bovine tb

Location

London

Description

Contract for the provision of External Audit of BCGcattle Phase 3

Total Quantity or Scope

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.​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.

Award Detail

Award Criteria

CPV Codes

• 73210000 - Research consultancy services

Indicators

• Award on basis of price.

Legal Justification

The justification of the direct award to Clinical Research and Communication (CRC) is due to previous expertise in this cattle vaccine trial under a previous contract for these services for this programme of work therefore continuation of this work under a new contract is required. The supplier’s knowledge and understanding of the trial is vital to the success of this project which has seen considerable delays due to its complexity. There will be a risk of failure of the project if the supplier were to change at this critical stage.The justification for this STA/Direct award is under PCR 2015 Reg 32 - “Compatibility – the supplier has the relevant methodology to complete an assignment which was previously let by competitive tender”.