Section one: Contracting authority/entity
one.1) Name and addresses
THE UNIVERSITY OF BIRMINGHAM
Edgbaston
BIRMINGHAM
B152TT
Contact
Kseniya Samsonik
Country
United Kingdom
Region code
UKG31 - Birmingham
Companies House
RC000645
Internet address(es)
Main address
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
Glo-BNHL international clinical site monitoring
Reference number
SC12209/24
two.1.2) Main CPV code
- 73000000 - Research and development services and related consultancy services
two.1.3) Type of contract
Services
two.1.4) Short description
Glo-BNHL is an international multi-arm clinical trial developed in collaboration with a number of key childhood cancer research organisations, including Innovative Therapies for Children with Cancer (ITCC) and the European Intergroup for Childhood NHL (EICNHL) in Europe, and the Children's Oncology Group (COG) in North America. The trial will be delivered globally with support from these organisations and in partnership with the C17 Council in Canada and the Australia and New Zealand Children's Haematology and Oncology Group (ANZCHOG). The trial is jointly funded by Cancer Research UK, Fight Kids Cancer and industry collaborators (currently ADC Therapeutics and Regeneron Pharmaceuticals). The funding provided is contingent upon the use of vendors with a track record of delivering clinical trials of this kind.
The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham is not able to perform monitoring on an international scale, therefore a suitable third-party vendor must be engaged for this critical work.
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: £3,400,000
two.2) Description
two.2.3) Place of performance
NUTS codes
- UKG31 - Birmingham
two.2.4) Description of the procurement
Glo-BNHL is an international multi-arm clinical trial developed in collaboration with a number of key childhood cancer research organisations, including Innovative Therapies for Children with Cancer (ITCC) and the European Intergroup for Childhood NHL (EICNHL) in Europe, and the Children's Oncology Group (COG) in North America. The trial will be delivered globally with support from these organisations and in partnership with the C17 Council in Canada and the Australia and New Zealand Children's Haematology and Oncology Group (ANZCHOG). The trial is jointly funded by Cancer Research UK, Fight Kids Cancer and industry collaborators (currently ADC Therapeutics and Regeneron Pharmaceuticals). The funding provided is contingent upon the use of vendors with a track record of delivering clinical trials of this kind.
The Cancer Research UK Clinical Trials Unit (CRCTU) at the University of Birmingham is not able to perform monitoring on an international scale, therefore a suitable third-party vendor must be engaged for this critical work.
The preferred vendor for clinical site monitoring is Premier Research. Premier were selected in 2020 to work on the Far-RMS trial after going to tender because they most closely fulfilled our needs as detailed below:
They are familiar with working with academic institutions of our kind, with over 85% of their client base being emerging sponsors and academic institutes
They have extensive experience in haemato-oncology projects operating globally (194 projects to date)
They have experience in the paediatric arena (261 studies over the past 5 years, 17 of those global, haemato-oncology studies)
They have a specialised paediatric training programme to ensure staff understand the unique challenges of paediatric research
They have expertise in global monitoring, having conducted studies in 75 countries worldwide and having 21 offices worldwide
two.2.11) Information about options
Options: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Negotiated without a prior call for competition
- The works, supplies or services can be provided only by a particular economic operator for the following reason:
- absence of competition for technical reasons
Explanation:
The preferred vendor for clinical site monitoring is Premier Research.
They are familiar with working with academic institutions of our kind, with over 85% of their client base being emerging sponsors and academic institutes
They have extensive experience in haemato-oncology projects operating globally (194 projects to date)
They have experience in the paediatric arena (261 studies over the past 5 years, 17 of those global, haemato-oncology studies)
They have a specialised paediatric training programme to ensure staff understand the unique challenges of paediatric research
They have expertise in global monitoring, having conducted studies in 75 countries worldwide and having 21 offices worldwide
When deciding upon a partner to work with us on Glo-BNHL, we felt the expertise detailed above, as well as the following other considerations, made Premier the right choice for this trial::
Proven expertise in oncology trials, particularly rare disease trials
Proven expertise in paediatric trials
Proven expertise in global trials
Ability to perform interim and follow-up site monitoring visits (and proven experience of doing so) in the following countries: UK, Europe (Austria, Belgium, France, Germany, Italy, Netherlands, NOPHO (Sweden, Norway, Denmark, Finland), Poland, Spain), USA, Canada, Australia, New Zealand and Israel
Ability to perform interim and follow-up site monitoring visits across 45 sites
Ability to support the volume of data that will be produced by 30 patients per treatment arm according to the treatment schedule outlined in the Glo-BNHL protocol
Ability to work with the procedures and systems of the CRCTU at the University of Birmingham
Ability to develop a monitoring plan in conjunction with the Glo-BNHL trial management team
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: No
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
9 January 2024
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
Premier Research Group Limited
Reading
Country
United Kingdom
NUTS code
- UKJ11 - Berkshire
Companies House
04671020
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: £0.01
Section six. Complementary information
six.4) Procedures for review
six.4.1) Review body
University Of Birmingham
Edgbaston
Country
United Kingdom