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The information below includes a summary of what commercial costings are based on, how to cost a study at site level and tips on financial tracking.
Costings
Costings
Commercial companies adhere to the requirements provided by the National Directive on Commercial Contract Research Studies. This standardised approach to commercial costing aims to facilitate faster contracting and quicker set-up times. For more information click here.
In the UK, there are two tools used to facilitate this:
interactive Costing Tool (iCT): a standardised commercial costing methodology for resource and location based price calculations.
Model agreements: a suite of standard agreements designed for a range of research scenarios, including a model confidentiality agreement, and supported by guidance documents all available as templates within IRAS.
From October 2022 the commercial costing process changed to the National Contract Value Review (NCVR). In summary, all new Phase II-Phase IV commercial research in acute, specialist and mental health trusts will undergo a single review by the lead site. This reduces set-up times as rather than negotiating with individual sites, one the lead site will go through this process. More information on which studies are eligible can be found here.
Finance Tracking
Finance Tracking
Finance tracking is an important aspect of commercial research. Following negotiations and the signings of contracts, it is the responsibility of the site to track any activities by cross-checking the contract.
Often, commercial studies will send a proforma to sites stating how many patient visits have taken place and the costs accrued for this. After cross-checking this against site records to confirm the proforma is correct, the site can then invoice for this.
It addition to this, sites must keep track of all set-up costs and other costs accrued. This includes items such as pharmacy time, training (hourly rate), mail-outs, R&D costs, monitoring costs and more and invoice accordingly.
Below is an example financial tracking template with example study activities.
Top Tips for Costings Review
Top Tips for Costings Review
The process used by most if not all commercial funders, an interactive negotiation can be made by making comments, adding or reducing hours spent on specific tasks on CPMS. This is carried out by the NCVR Study Source Reviewer at the Lead site.
For example, the consenting process is typically costed at a medic and nurse for 1 hour of their time. This takes into account welcoming the participant, explaining the study, answering any questions and signing the consent form.
Within the iCT, the costs are separated out into Setup and Closedown and Study Activities. Make sure you look at each tab in detail.
Set a regular time to update financial tracking and send invoices so nothing is missed.
Keep note of how many staff, and how many hours of an activity staff have carried out. Some activity items are costed per hour not per activity.
If you are new or unsure about commercial costings and would like some additional support, please contact the CRN using em.rrdn@nihr.ac.uk.
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