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

As part of a  phase of improvements led by NHS England and NHS Improvement, being implemented during 2019/20, the concept of a national contract value review process was introduced. This is a nationally coordinated contract value negotiation process. It will ensure a fair, transparent and consistent approach to research costing across the country - and reduce the need for resource allocation negotiation, focusing negotiations at individual sites only on specific local requirements. 

A number of NHS sites that are experienced in commercial research are currently testing the proposed national contract value review process, which will enable an analysis of its impact.

In the next phase of implementation, a national coordinator will be assigned to each commercial contract study to negotiate the resource and procedure allocation required to deliver the study in the NHS. Once the company has accepted the allocation it will be ‘validated’ and issued to all participating NHS sites for local costing - using the mandated national costing methodology (the NIHR costing tool or template). Additional resource requests from participating sites can be submitted, but the sponsor company will be able to ask for a justification for the request - and an audit trail for these requests will be generated.

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
  • Separates national resource allocation for the study from specific local site resource allocation
  • Builds on local expertise to establish a national process for defining and allocating resource and procedure requirements

Webinars: National contract value review process explained

In November 2019, NHS England in partnership with the NIHR delivered a series of webinars aimed at industry and the R&D community on the new national contract value review process. You can re-play the webinars below.

 Sign up to receive our industry newsletter to stay up to date on the latest developments.


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 have been designed for a range of various research scenarios and are supported by guidance documents.


Standard costing methodology (Costing Tool/Template)

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 provides a framework for transparent cost display and calculation to support swift local site budget negotiations. 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. Currently the standard commercial contract research costing methodology is available in two formats:

interactive Costing Tool (iCT)

From 1 April 2020, all industry costing submissions for new studies must be submitted using the online interactive Costing Tool (iCT). The previous Excel-based version and supporting guidance have now been removed from the website.

The iCT is a digital (web-based) version of the previous Excel Industry Costing Templates (now discontinued). You will need to create an  NIHR Central Portfolio Management System (CPMS) account to use the interactive Costing Tool (follow the link and click on  ‘create an account’).  

A number of helpful films about the new iCT are available on our NIHRtv Youtube channel, including submission guidance for life sciences industry. To find out more and access the  iCT read the guidance:

iCT - March 2020 update: To speed up and streamline sponsor companies use of the system in future, we have now  implemented two changes to the iCT on CPMS - following recommendations by users. These are:

  • Company representatives can now add site representatives to studies directly
  • Setup and Closedown costs have been moved from study-level only, to show at the site level. 

How to get your study costing validated

The Local Clinical Research Network (LCRN) leading on the study (usually where the Chief Investigator site is located) will perform a quick ‘quality check’ or validation of the study specific costing.  This validation is required prior to HRA Approval and an application for the NIHR Clinical Research Network Portfolio is required before the validation can take place.

The validation ensures that all protocol required procedures, investigations and tasks are included in the template and highlights areas where additional activities may be required for inclusion to capture all the requirements for the site. The validation does not consider the price, time value or standard of care status for any study activities as this currently remains the responsibility of each participating organisation to consider during local capacity and capability activities. See what checks are included in the validation. The final stage is gaining cost approval from each individual NHS organisation.

How to include the study costings in the contract

Suggested content for the Financial Appendix of the model site agreements has been developed to support the inclusion of the study specific costing into the contract. This content is included as a direct output of the iCT.

How to update the costs in the contract

Understand what income distribution could look like in your NHS organisation by reading the NIHR Clinical Research Network Income Distribution Model.

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. Once fully implemented, a streamlined approach to a UK wide contract review process will be piloted. Ongoing projects are in place to continue to bring together all devolved administrations to enable a smoother and quicker start up 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:

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.

Related pages


External links