Faster costing and contracting

A new, standardised, national approach to costing and contracting for commercial contract research is being introduced across NHS sites in England to improve consistency and reduce unnecessary delays to study set-up.

Life science organisations and Contract Research Organisations (CROs) choosing to conduct clinical research in our NHS will experience quicker and easier multi-site study set-up:

Less time negotiating costs and contracts with multiple sites
More consistency when defining resource and procedure requirements across the country
Better transparency in how resource requirement is costed across the country
Better predictability of the overall costs to deliver a multi site study
Reduced administration requirements

National contract value review process

Overview / background

The national contract value review (NCVR) is a joint programme being led by NHS England and NHS Improvement (NHSE/I) and is part of a UK-wide approach. It is one of a range of activities aimed at making it easier and faster to set-up commercial trials in the UK and focuses on the resource-agreement step of study set-up.

While the National Directive on commercial contract research for the process came into force in April 2019, the NCVR programme paused at the beginning of the pandemic - which was followed by a period of review to update principles and processes. This has resulted in a staged approach to implementation from April 2022 - starting with a data collection exercise with NHS organisations , which will be followed at a later date by the national review roll-out.

For more information on the national contract value review, read the following NHSE/I pages:

Principles of stage one implementation

NHS organisations will be asked to indicate whether they adhere to local interactive Costing Tool (iCT) generated prices or not. Industry will be able to select sites informed by this knowledge.
The NIHR Clinical Research Network (CRN) will identify a contract value review coordinator, who will work in partnership with industry to undertake a contract value review and confirm the correct study requirements in the iCT
Where sites adhere to the local iCT generated price, the finance schedule in the relevant model agreement will reflect the finalised study values in the interactive Costing Tool. There will be no further local negotiations beyond non-iCT item prices.
Where a site does not adhere to the local iCT generated price, local negotiations will take place - informed by the local iCT generated price.
The study model agreement and finance schedule will be signed when local capacity and capability can be confirmed.

Further developments

The final NCVR process (or 'end product'_ will be informed by learning from stage 1 of the roll-out, but will also include:

Site specific organisational costs being available upfront, prior to study negotiation commencing
Transparent costs
A single national negotiation of study costs, with no local negotiation

Benefits of the new national contract value review process:

A new, standardised, national approach to costing and contracting for commercial contract research
Improved consistency and standardisation in study set-up
Increasing the speed and efficiency of research set-up in England - increasing the capacity for more research in the NHS
Builds on local expertise to establish a national process for defining and allocating resource and procedure requirements

Model site agreements

As of 1 October 2018 - all NHS sites, life science companies and/or CROs conducting commercial contract clinical research in the NHS are mandated to use an unmodified model site agreement. These are nationally accepted contract terms which, when used without modification, will eliminate delays caused by contract negotiations and legal reviews for each NHS site delivering your study. They are also a required document for acquiring Health Research Authority (HRA) approval (combined governance, legal, ethics approvals).

The suite of model site agreements, available as templates within IRAS, have been designed for a range of various research scenarios and are supported by guidance documents.

Standard costing methodology: the interactive Costing Tool (iCT)

As of 1 October 2018 all NHS sites in England conducting commercial contract clinical research are also mandated to use the NIHR standard costing methodology when contracting with life science companies and/or CROs.

The standard methodology, via the NIHR interactive Costing Tool, provides a framework for transparent cost display and calculation to support swift local site budget negotiations for inclusion in the financial appendix of the model agreements. This means less variation when defining resource requirements across the country, better transparency in how that resource requirement is costed locally, and better predictability of overall study delivery costs.

Everything you need to get started with the interactive Costing Tool (iCT)

Further information

The NHS England and NHS Improvement National Directive on Commercial Contract Research Studies

These changes are being implemented in response to the feedback from life sciences industry partners which was acquired through the NHS England and NHS Improvement consultation on Supporting Research in the NHS. Following the consultation, on 1 October 2018 a National Directive on Commercial Contract Research Studies came into force setting out the requirements that NHS service providers need to adhere to when delivering commercial contract research. Development and implementation of the directive has been led by NHS England and NHS Improvement in partnership with NIHR and HRA.

Working across the UK

Although the national contract value review process approach is being led by NHS England and NHS Improvement, the costing and contracting tools, models and associated template agreements are accessible throughout the UK, including Northern Ireland, Wales, and Scotland. The staged implementation includes a streamlined approach to a UK wide contract review process.

Contact us

If you didn't find what you were looking for or if have any questions or comments 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.

Run your study in the NHSFree support to plan, place and perform commercial clinical research in the UK’s National Health Service (NHS).National Patient Recruitment CentresThe National Patient Recruitment Centres (PRCs) set up and deliver late phase commercial clinical trials at pace and scale in the UK.Clinical Research NetworkThe NIHR Clinical Research Network funds and manages infrastructure to support high-quality health and care research in England.