Official UK procurement notice
Provision of Clinical Trial Monitoring to the FaR-RMS Trial
Authority: Tender for the Provision of Clinical Trial Monitoring to the FaR-RMS Trial
What is being bought
Published requirement descriptionThe FaR-RMS trial The University of Birmingham Cancer Research Clinical Trials Unit are working on a collaboration with a large Pharmaceutical company to add a new arm to an existing study. The trial is a multicentre, randomised phase II trial evaluating the new therapy against a control arm in paediatric patients with relapsed/refractory rhabdomyosarcoma. Patients will receive therapy for up to 12 cycles (approx. 12 months) and will be followed-up for 5 years.
CPV: Clinical information system · Design and execution of research and development · Patient-monitoring system
The lotProcurement structure
single lot · no lot value publishedLot #1The University of Birmingham Cancer Research Clinical Trials Unit are working on a…
The University of Birmingham Cancer Research Clinical Trials Unit are working on a collaboration with a large Pharmaceutical company to add a new arm to an existing study. The trial is a multicentre, randomised phase II trial evaluating the new therapy against a control arm in paediatric patients with relapsed/refractory rhabdomyosarcoma. Patients will receive therapy for up to 12 cycles (approx. 12 months) and will be followed-up for 5 years.
What it takes to wini
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
Evaluation split and conditions of participation as published; the tender pack may add morei
How this buyer will score bids.
The evaluation criteria and weights exactly as published on the notice, grouped by family (price, quality, social value and so on).
Published sub-criteria (1)
- Cost: 15
Published award criteria (1)
- Cost: 15%
- Price carries 15 of 15 points: a 10% discount moves about 1.5 points. This one is won on the number: sharpen the price before polishing the prose.
Price arithmetic assumes straight proportional scoring; the tender pack may use another formula.
Procedure terms & legal framework
From the official record · publisher note attached- Procedure method
- Open procedure
- Legal basis
- CELEX · 32014L0024 Public Contracts Regulations 2015 (Directive 2014/24/EU)
- Procurement category
- Services
- Notice status
- Closed
- Procurement threshold
- Unspecified in notice
- Regulatory regime
- Standard
- Commercial structure
- Stand-alone contract (no framework)
- Competition type
- Competitive procedure
- GPA / WTO covered
- Yes (GPA)
- Recurring procurement
- No (one-off requirement)
- First published
- 31 Mar 2021, 14:30 BST
- Last source update
- 31 Mar 2021, 14:30 BST
- Award evaluation window
- 30 Apr 2021 – …
- Authority reference
SC9073/21- FTS notice number
2021/S 000-006675- Classification (CPV)
- Delivery area
- Official registry OCID
ocds-h6vhtk-02a184Find a Tender
Publisher note: The proposed start date for recruitment is June 2021. We will require clinical trial monitoring services to perform on-site Source Data Verification (SDV) and monitoring of the conduct of the trial in participating sites in Europe, Canada and Asia Pacific. Information on services required:The Sponsor (University of Birmingham) shall retain overall regulatory responsibility in its capacity as the Sponsor of the Clinical Trial pursuant and under to the Regulations.The Sponsor will enter into a separate agreement with the selected tenderer outlining the clinical trial monitoring requirements. It is anticipated that on-site monitoring services will be required at regular intervals during the recruitment and treatment stages of the trial. It is envisaged the first site will open to recruitment in Jun 2021 and monitoring the first monitoring visits will be performed in July/August 2021. Monitoring Requirements The tenderer will work closely with the Sponsor team to effectively monitor the trial conduct at sites. The Sponsor team will perform Site Initiation visits and remote monitoring of sites and we are seeking tenderer to specifically perform the on-site visits and report the findings to the Sponsor team. Active Site Management (e.g., monitoring and reporting recruitment, provision of documents, general issues) is not required by the tenderer as this will be performed by the Sponsor team. However, the tenderer will be required to follow-up matters specifically related to the on-site monitoring visits that they have performed. A separate close-out visit is not required and where possible, close-out activities should be performed within the number of visits planned for sites (see table-below). The tenderer will have a one-to-one relationship with the Sponsor team to ensure the smooth and efficient running of the trial.
How it was run
Official notice- Submission deadline
- 30 Apr 2021, 12:00 BST
- Submission channel
- {"written"}
- Accepted languages
- en
- Bids opened
- 30 Apr 2021, 12:00 BST
Timeline
31 Mar 2021 → 30 Apr 2021 · 3 dates- Notice published31 Mar 2021, 14:30 BST
- Submission deadline30 Apr 2021, 12:00 BST
- Bids opened30 Apr 2021, 12:00 BST
Contracting authority & participating public bodies
Dispute resolution & review bodies
- University of BirminghamReview body
Official documents & specifications
Official links; attachments are not copiedNo document links were published on the notice.