Section one: Contracting authority/entity
one.1) Name and addresses
UNIVERSITY OF BIRMINGHAM
Edgbaston
BIRMINGHAM
B152TT
Contact
Paul Markham
Country
United Kingdom
NUTS code
UKG31 - Birmingham
Internet address(es)
Main address
https://www.birmingham.ac.uk/index.aspx
one.4) Type of the contracting authority
Body governed by public law
one.5) Main activity
Education
Section two: Object
two.1) Scope of the procurement
two.1.1) Title
FaR-RMS Trial - Clinical trial database
Reference number
SC9502/21
two.1.2) Main CPV code
- 72320000 - Database services
- LA23 - For medical use
two.1.3) Type of contract
Services
two.1.4) Short description
The FaR-RMS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by Cancer Research UK and Bayer AG. The funding is contingent upon having a suitably compliant clinical trial database that is active and ready for use by the end of 2021. Funding is provided to support the trial to be compliant with additional regulations. The trial used an existing clinical trial database (also sourced externally) however upon review, the existing clinical trial database is not suitable for the revised scope of the trial. Therefore, a new clinical trial database that is regulatory compliant, is able to be delivered within a tight timeline and fall within budget is required.
two.1.6) Information about lots
This contract is divided into lots: No
two.1.7) Total value of the procurement (excluding VAT)
Value excluding VAT: £500,000
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKG - West Midlands (England)
Main site or place of performance
University of Birmingham,
Edgbaston,
Birmingham
Some work carried out at supplier premises:
Uppsala, Sweden
two.2.4) Description of the procurement
The FaR-RMS trial (Sponsored by the University of Birmingham) is an Investigator Initiated Trial which is funded by Cancer Research UK and Bayer AG. The funding is contingent upon having a suitably compliant clinical trial database that is active and ready for use by the end of 2021. Funding is provided to support the trial to be compliant with additional regulations. The trial used an existing clinical trial database (also sourced externally) however upon review, the existing clinical trial database is not suitable for the revised scope of the trial. Therefore, a new clinical trial database that is regulatory compliant, is able to be delivered within a tight timeline and fall within budget is required.
The preferred vendor for creating a clinical trial database for this trial is Viedoc TM.Viedoc TM meets the criteria outlined below that are essential for delivering the clinical trial. The company has a track record of delivering clinical trials to registration standard with other academic organisations running clinical trials of this nature (international, paediatric oncology trials with multiple arms) and was independently recommended to the University of Birmingham. Additionally, Viedoc TM is in the process of undergoing a detailed audit of their systems with the University of Birmingham. This is an essential requirement to perform prior to the set-up of an electronic clinical trial database when required for registration standard trials. Viedoc TM have confirmed their ability to deliver the clinical trial database in 2021 and within the budget. The detailed audit of Viedoc TM has also confirmed that it is compliant with the regulations and is therefore suitable for use in the FaR-RMS trial.
two.2.11) Information about options
Options: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Award of a contract without prior publication of a call for competition in the cases listed below
- The procurement falls outside the scope of application of the regulations
Explanation:
The preferred vendor for creating a clinical trial database for this trial is Viedoc TM.Viedoc TM meets the criteria outlined below that are essential for delivering the clinical trial. The company has a track record of delivering clinical trials to registration standard with other academic organisations running clinical trials of this nature (international, paediatric oncology trials with multiple arms) and was independently recommended to the University of Birmingham. Additionally, Viedoc TM is in the process of undergoing a detailed audit of their systems with the University of Birmingham. This is an essential requirement to perform prior to the set-up of an electronic clinical trial database when required for registration standard trials. Viedoc TM have confirmed their ability to deliver the clinical trial database in 2021 and within the budget. The detailed audit of Viedoc TM has also confirmed that it is compliant with the regulations and is therefore suitable for use in the FaR-RMS trial.
The following are detailed reasons for the selection of Viedoc TM as a vendor to provide a clinical trial database for FaR-RMS:
• Able to perform a 'rescue' mission and align an existing clinical database that is in use into a single database for the study
• Able to deliver a live clinical trial database for the study in 2021
• Qualified by the University of Birmingham as a regulatory compliant clinical trial database
• Fall under a maximum budget of £500,000 for the whole clinical trial database
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
Section five. Award of contract/concession
A contract/lot is awarded: Yes
five.2) Award of contract/concession
five.2.1) Date of conclusion of the contract
4 October 2021
five.2.2) Information about tenders
The contract has been awarded to a group of economic operators: No
five.2.3) Name and address of the contractor/concessionaire
Viedoc Technologies AB
S:t Persgatan 6
Uppsala
75320
Country
Sweden
NUTS code
- SE - Sweden
Internet address
The contractor/concessionaire is an SME
No
five.2.4) Information on value of contract/lot/concession (excluding VAT)
Total value of the contract/lot/concession: £500,000
Section six. Complementary information
six.3) Additional information
The standstill period for this VEAT notice will expire at midnight at the end of Monday 18th October 2021.
six.4) Procedures for review
six.4.1) Review body
The University of Birmingham
Edgbaston
Birmingham
B15 2TT
Country
United Kingdom