Helping industry to navigate the UK research landscape
We know that bringing a new therapeutic product to market can be a tricky and expensive business
If you have your sights set on the NHS, then you’ll need to run clinical trials or studies here in the UK to generate the clinical and economic evidence for your NICE technology appraisal.
This is where we can help
We want your journey to be as smooth as possible and there are a range of different services that have been designed to help you navigate the UK research landscape. Use the time-line below to find out more about the different kinds of help and support available from the NIHR and NICE.
Concept
NIHR Study Support Service: Advice and guidance
Get started with free advice and guidance to help you explore the support that is available in the UK for your clinical study.
NICE Office for Market Access (OMA)
Engage with NICE and other key stakeholders from the healthcare system as you develop your market access strategy.
NIHR Patient Engagement in Clinical Development
Engage directly with patients who can help shape and improve your clinical trial or study protocol.
NICE Scientific Advice for Pharmaceuticals
A comprehensive advisory service to help you optimise your evidence generation plans to demonstrate the value of your product.
NICE Scientific Advice for Medtech
A lighter advisory service to help smaller medtech companies optimise your evidence generation plans to demonstrate the value of your product.
Feasibility
NIHR Study Support Service: Feasibility services
Gather expressions of interest to deliver your study from investigators and sites throughout the NHS, including general practice. Or use our site intelligence service to sense check your pre-selected site targets.
Concept phase: NIHR Study Support Service: Advice and Guidance
We will provide you with personalised, one-to-one advice about all the different areas of support available to you. This advice is completely free of charge and will include:
- access to NIHR expert opinion to help you understand the UK research landscape and the UK track record of studies (academic and commercial) in your therapy area of interest
- exploration of recruitment potential and patient care pathways
- advice on eligibility for accessing support from our research workforce embedded in the NHS at site level
- guidance on regulatory submissions
- access to and support to use our interactive Costing Tool (iCT) and model site agreements
- information about available GCP training
- signposting to other support services you may find helpful.
The earlier you engage with us, the greater impact we can have on the successful delivery of your study.
Use our contact form to access this service. The earlier you get in touch the more you will benefit from our support.
Concept phase: NICE Office for Market Access (OMA)
Engage with NICE and other key stakeholders from the healthcare system as you develop your market access strategy.
We enable companies at all stages of product development and commercialisation to gain valuable insights. These can help you get new and innovative products adopted as quickly as possible. We bring together the best people to help you gain insight for your market access planning in a safe harbour environment.
Design phase: NIHR Study Support Service: Protocol Feedback
We will help you to determine if your study is compatible with UK clinical practice and if it can be delivered in the NHS. All you need to do is submit a synopsis or draft protocol and we will do the rest. This service is completely free of charge.
Our nationwide network enables us to efficiently and rapidly provide you with feedback from NHS clinical experts and key opinion leaders from the relevant therapeutic area. Our experts will look at elements such as study complexity, patient population, time lines and recruitment strategy. They will offer valuable suggestions to improve study design and delivery and increase the potential of achieving your recruitment target on time.
Use our contact form to access this service. The earlier you get in touch the more you will benefit from our support.
Design phase: NIHR Patient Engagement in Clinical Development
The primary aim of the service is to bring patients and life science companies together earlier in the clinical development process, before a study protocol is finalised, so that patients can help companies to make the trial design as patient-friendly as it can be. The NIHR is in a unique position to be able to broker this relationship as a neutral, public sector organisation, working in close partnership with the NHS, with a long history and track record of supporting the life science industry to deliver clinical research in the NHS.
This service operates a full cost recovery model.
Find out more about the NIHR Patient Engagement in Clinical Development service
Design phase: NICE Scientific Advice for Pharmaceuticals
Seek answers to your questions through our comprehensive, confidential and non-binding advisory service. The 18-week standard advice service helps you optimise evidence generation plans to demonstrate the value of your product.
- A meeting with NICE and a panel of leading experts allows you to explore important issues.
- A report answers your questions and sets out NICE’s advice and insights.
Our Express version of this service offers the same features but on a 12-week time line. This is suited for more focused engagements where timeliness is key.
Find out more about NICE Scientific Advice for Pharmaceuticals
Design phase: NICE Scientific Advice for Medtech
MedTech advice is designed specifically for developers of medical devices, diagnostics and digital health technologies. It offers a hybrid service that combines a META Tool consultation with our more traditional scientific advice services.
With MedTech advice, you'll get a high-level gap analysis of your evidence base. You'll also get advice on the key issues around your prospective evidence generation plans and your approach to economic modelling.
Feasibility phase: NIHR Feasibility Services
Our free feasibility services can help you to place your study more strategically to optimise study performance.
- Identify sites for your study - We use our national network to quickly gather expressions of interest from investigators at sites throughout the NHS, including primary care (general practice) and social care. Interested sites are required to respond within 15 working days.
- Data driven site selection - Our national, real-time, research activity data identifies locations with the best recruitment potential, and our site level data sense checks recruitment targets for pre-selected sites.
Use our contact form to access this service. The earlier you get in touch the more you will benefit from our support.