Costing and contracting using National Contract Value Review (NCVR)
Essential information on the UK-wide standardised, national approach to costing and contracting for commercial contract research; National Contract Value Review (NCVR), and the tools you will need to use to complete the process.
The benefits of the NCVR
The NHS is made up of many separate organisations in the UK. NCVR is a system-wide process that enables those organisations to work collaboratively, as one single organisation, to speed up the costing and contracting activities for commercial sponsors setting up multi-site studies.
It achieves this by using model agreements and a standardised pricing structure. This UK-wide approach is currently mandatory for commercial companies delivering late-phase clinical trials in NHS trusts and will soon be mandatory for all phases of clinical trials.
The main benefits of NCVR are:
- Consistency: Commercial sponsors can expect the same approach and service across all sites
- Transparency and predictability: Commercial sponsors have better visibility and understanding of costs and impact on study budgets
- Improved efficiency: Reducing the administrative burden of study set-up unlocks capacity for more research in the NHS
- Faster study set-up: In October 2023 we reported that NCVR has reduced commercial study set up times by a third
- Faster access to cutting-edge treatments for patients taking part in those trials
How does NCVR work?
NCVR is a collaborative process delivered by people (NHS/sponsor/NIHR) and underpinned by two UK-wide tools:
- UK interactive Costing Tool (iCT): a web-based tool through which the UK’s standardised costing methodology is accessed and applied to commercial clinical trials. This tool is used for determining resource requirements for study delivery at a national level, and also for calculating site-specific prices. This tool is managed by the NIHR.
- Model agreements: a suite of standard agreements designed for a range of research scenarios, including a model confidentiality agreement. These are available as templates, with supporting guidance, within the Integrated Research Application Service (IRAS) which is managed by the Health Research Authority (HRA).
The key stages of the NCVR process for each multi-site commercial clinical study are:
1. The commercial sponsor populates the UK interactive Costing Tool (iCT) to reflect their initial interpretation of resource requirements to fulfil the study protocol.
2. The commercial sponsor is connected to an NHS costing expert who will conduct a study resource review to enable agreement by both sides on actual resource requirements.
3. Once approved, the iCT is shared with all participating NHS organisations to generate site-specific prices. This is a pre-defined, UK-wide methodology that ensures full cost recovery and accounts for aspects such as geographical variation, outsourcing costs etc.
4. The output from the iCT is inserted directly into the unmodifiable standard financial appendix within the model agreement (your contract with your sites).
Does NCVR apply to all commercial research?
NCVR stage 2 commenced in October 2023 making NCVR mandatory for all late phase commercial trials (phase 2b and above) taking place in NHS organisations.
Currently, NCVR is not mandatory for phase 1-2a, Advanced Therapy Medicinal Products (ATMP) studies and studies running in Primary Care. However, many NHS organisations are voluntarily accepting the resource review outcome and iCT generated prices for these studies. Preparation is underway to bring early-phase and ATMP studies into the NCVR programme. Learn more on the NHS England website.
How NCVR is being implemented in primary care
As independent contractors providing NHS services, GPs (General Practice) are not currently required to adhere to the prices generated by the interactive Costing Tool. However, since 20 November 2023 GP practices have been able to sign up to a voluntary scheme to register their commitment to accepting NCVR prices and stopping local negotiations.
Commercial sponsors can now consult the list of GPs (General Practice) accepting NCVR prices when making their site selection decisions. This list is accessed via a dedicated NCVR Primary Care dashboard.
Begin by accessing the interactive Costing Tool (iCT)
To submit your study for the National Contract Value Review you will need to access the iCT. We have a number of resources available to help you get started.
Take a look at Guidance: Using the interactive Costing Tool (iCT) This digital guidance document provides detailed information about how to get started using the tool, the latest functionality updates, and how to provide feedback. It also includes links to a suite of helpful infographics which explain the NCVR process and the different roles of the people involved.
Our 10 step user guide to our Study Support Service for the life sciences industry will help you to navigate the different areas of support provided through the NIHR Study Support Service - including NCVR. It sets out what is available, step by step, in a logical order to help you access the right support at the right time to maximise the benefits and minimise delays. It includes essential information and top tips for using the iCT as part of the NCVR process.
If you are interested in where the pricing data comes from, take a look at our supporting information on How the interactive Costing Tool (iCT) calculates the costs of studies at sites. This digital document provides information about the data sources which enable the interactive Costing Tool (iCT) to calculate the costs of studies at sites and how to submit suggestions for the future development of the iCT.
Request NCVR support
If you need help submitting your study for National Contract Value Review please contact the Study Support Service Helpdesk: supportmystudy@nihr.ac.uk
If your study is already part of the NIHR Clinical Research Network Portfolio and you need support or help with a specific site, please contact your local Industry Operations Manager for support.
Tariff data and further information
Read information about how the interactive Costing Tool (iCT) calculates the costs of studies at sites. This includes links to the prices (tariffs) data.
Documents
- Guidance: Using the interactive Costing Tool (iCT)
- Model Site Agreements and guidance
- What the NHS National Directive on Commercial Contract Research Studies means for the Life Sciences Sector
- NIHR Clinical Research Network Income Distribution Model
- Eligibility criteria for NIHR Clinical Research Network support for commercial studies
External links
Explore more support from the NIHR
This service is just one of the ways we help life science organisations. Visit our NIHR support for industry page to discover our full range of support or explore all our services and support.
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Contact the Industry team
If you need help submitting your study for National Contract Value Review please contact the Study Support Service Helpdesk:
If your study is already part of the NIHR Clinical Research Network Portfolio and you need support or help with a specific site please contact your local Industry Operations Manager.
If you have not delivered a study in the UK before and need help or advice, complete our contact form to request a chat with our team. We aim to reply as soon as possible and always within two business days.