This service is designed for people seeking clinical or economic advice on the design of upcoming trials or studies. It provides the highest level of detail of all our scientific advice processes.
The service includes:
- A 3 hour virtual meeting.
- A detailed advice report with references and background information.
- Feedback on your development plan from a panel of experts. This will include clinical, health economic, patient and health technology assessment specialists.
- An optional clarification phase after receiving advice.
I truly value this scientific advice service provided by NICE. It creates fantastic opportunities for global drug development teams to better understand reimbursement hurdles and evidence requirements for timely market access.
Briefing book submission
The briefing book provides us with all the important information about your project. It should include details such as:
- background information
- details on your upcoming trials
- your questions for NICE.
The briefing book submission requirements are different for pharmaceutical and medical technologies.
Once the project timeline has been provisionally agreed, we will share the latest version of the briefing book template and supporting guidance to help you in your preparations.
The process
If you think you've left it too late to seek scientific advice, contact us. We may still be able to help.
Advice timeline
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First contact
Following your initial enquiry, we send you a preliminary questions form to complete. We agree a timeline and send you our standard contract, briefing book template and supporting guidance.
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You sign and return the contract
This must be done in advance of the draft briefing book submission. The Project Team will confirm the deadline as part of the timeline.
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Send us your draft briefing book
This is the key document that sets the scope of the project. It should include details of your proposals and the questions you want to ask NICE.
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We send you a quote
Based on the content of your draft briefing book, we send you an initial quote for the project fee. You then have an opportunity to make any further changes to your briefing book before submitting a final version.
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wk1
Submit your final briefing book
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We confirm the project fee
Once we've reviewed the final briefing book, we confirm the project fee. This may differ from the initial quote, if any significant changes were made to your briefing book.
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wk6
We may ask some clarification questions about your briefing book
Having identified and spoken to our panel of experts, we may ask you to clarify or provide further information on certain details in your briefing book.
You'll have approximately 2 weeks to respond.
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wk10
Meeting with NICE and a panel of experts
Your team takes part in a 3 hour virtual meeting with NICE and a panel of experts. This is an exploratory open discussion of the key issues we've identified in your briefing book and helps us formulate our answers for the final advice report.
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wk18
We send our advice report
This is a detailed report with background, relevant case history and a comprehensive written response to each question posed in your briefing book.
Please allow a further 2 weeks if your project is classified as large.
Clarification stage (optional)
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+3 wks
You can send us any clarification questions you have about the report
These questions are to clarify the meaning of the advice and cannot be requests for new information.
Further follow-up advice can be arranged for an additional fee. Please contact us to discuss any requirements.
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+7 wks
We respond to your clarification questions, in writing