Glo-BNHL international clinical site monitoring

Concepts

• birmingham
• research and development
• clinical site monitoring
• global monitoring
• clinical trials
• monitoring
• glo-bnhl international clinical site monitoring
• an international multi-arm clinical trial
• the cancer research uk clinical trials unit
• clinical

Location

BIRMINGHAM

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.

Total Quantity or Scope

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

Award Detail

CPV Codes

• 73000000 - Research and development services and related consultancy services

Indicators

Legal 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