Section one: Contracting authority
one.1) Name and addresses
Tender for the Provision of Clinical Trial Monitoring to the FaR-RMS Trial
University of Birmingham
Edgbaston
B15 2TT
Contact
Peter Nobbs
Country
United Kingdom
NUTS code
UKG31 - Birmingham
Internet address(es)
Main address
one.3) Communication
The procurement documents are available for unrestricted and full direct access, free of charge, at
https://in-tendhost.co.uk/universityofbirmingham/aspx/Home
Additional information can be obtained from the above-mentioned address
Tenders or requests to participate must be submitted to the above-mentioned 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
Provision of Clinical Trial Monitoring to the FaR-RMS Trial
Reference number
SC9073/21
two.1.2) Main CPV code
- 73300000 - Design and execution of research and development
two.1.3) Type of contract
Services
two.1.4) Short description
The 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.
two.1.6) Information about lots
This contract is divided into lots: No
two.2) Description
two.2.2) Additional CPV code(s)
- 48814400 - Clinical information system
- 33195000 - Patient-monitoring system
two.2.3) Place of performance
NUTS codes
- UKG31 - Birmingham
two.2.4) Description of the procurement
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.
two.2.5) Award criteria
Cost criterion - Name: Cost / Weighting: 15%
two.2.7) Duration of the contract, framework agreement or dynamic purchasing system
Duration in months
72
This contract is subject to renewal
No
two.2.10) Information about variants
Variants will be accepted: No
two.2.11) Information about options
Options: No
two.2.13) Information about European Union Funds
The procurement is related to a project and/or programme financed by European Union funds: No
Section four. Procedure
four.1) Description
four.1.1) Type of procedure
Open procedure
four.1.8) Information about the Government Procurement Agreement (GPA)
The procurement is covered by the Government Procurement Agreement: Yes
four.2) Administrative information
four.2.2) Time limit for receipt of tenders or requests to participate
Date
30 April 2021
Local time
12:00pm
four.2.4) Languages in which tenders or requests to participate may be submitted
English
four.2.7) Conditions for opening of tenders
Date
30 April 2021
Local time
12:00pm
Section six. Complementary information
six.1) Information about recurrence
This is a recurrent procurement: No
six.3) Additional information
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.
six.4) Procedures for review
six.4.1) Review body
University of Birmingham
Edgbaston
B15 2TT
Country
United Kingdom