Official UK procurement notice
Glo-BNHL international clinical site monitoring
Authority: THE UNIVERSITY OF BIRMINGHAM (Education)
What is being bought
Published requirement descriptionGlo-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.
CPV: Research and development services and related consultancy services
The lotProcurement structure
single lot · no lot value publishedLot #1
Procedure terms & legal framework
From the official record- Procedure method
- Negotiated without publication of a contract notice
- Legal basis
- CELEX · 32014L0024 Public Contracts Regulations 2015 (Directive 2014/24/EU)
- Procurement category
- Services
- Notice status
- Awarded
- Procurement threshold
- Unspecified in notice
- Regulatory regime
- Standard
- Commercial structure
- Stand-alone contract (no framework)
- Competition type
- Competitive procedure
- GPA / WTO covered
- Unspecified in notice
- Recurring procurement
- Unspecified in notice
- First published
- 9 Jan 2024, 15:08 GMT
- Last source update
- 9 Jan 2024, 15:08 GMT
- Authority reference
SC12209/24- FTS notice number
2024/S 000-000664- Classification (CPV)
- Delivery area
- Official registry OCID
ocds-h6vhtk-042bb3Find a Tender
- Why no open competition
The works, supplies or services can be provided only by a particular economic operator due to absence of competition for technical reasons
- Published justification
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
Commercial outcome & contract awards
Published awards, contracts and bid statistics, not a forecast| Awarded to | Value | Date | Status |
|---|---|---|---|
| Premier Research Group Limited | £0 † | — | Awarded |
Contracts
Contract 000664-2024-1 · Premier Research Group Limited
- Signed
- 9 Jan 2024
- Value
- £0
- Status
- active
Contracting authority & participating public bodies
Dispute resolution & review bodies
- University Of BirminghamReview body
Bidders & participating suppliers
1 commercial party on the notice- Premier Research Group LimitedAwarded supplier
Official documents & specifications
Official links; attachments are not copiedNo document links were published on the notice.