Provision of Clinical Trial Monitoring to the FaR-RMS Trial

Concepts

• university of birmingham cancer research clinical trials unit
• provision of clinical trial
• research and development
• edgbaston
• far-rms trial
• clinical information system
• trial
• patient monitoring system
• design and execution
• paediatric patients

Location

Edgbaston

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.

Award Criteria

CPV Codes

• 73300000 - Design and execution of research and development
• 48814400 - Clinical information system
• 33195000 - Patient-monitoring system

Indicators

• Bids should cover the whole contract.
• Renewals are not available.
• Award on basis of price and quality.

Other 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.