Streamline your study set-up and monitor progress
Free support for commercial sponsors to streamline study set-up across multiple sites. We can also help to monitor study progress against study milestones.
Our role in supporting faster study set-up
Study set-up comprises a number of different activities involving multiple organisations. This includes gaining study-wide regulatory approval and ethical approval, costing and contracting with individual sites, followed by study initiation at each site.
UK-wide processes have been implemented to enable the organisations involved to work collaboratively to speed up study set-up activities for commercial sponsors conducting multi-site studies.
For example, the Combined Review Service co-ordinates regulatory and ethical approvals for Clinical Trials of Investigational Medicinal Products (CTIMPs) applications through a single process. The National Contract Value Review process (NCVR) has reduced commercial study set-up times by a third by introducing a UK-wide standardised approach to costing and contracting.
Once the regulatory approvals, costing and contracting activities are complete we (the NIHR) can support you (the commercial sponsor or Contract Research Organisation) to coordinate set-up activities across your different sites.
Help to coordinate set-up across multiple sites
The NHS is made up of many separate organisations across the UK. Consequently, different NHS organisations will be responsible for setting up and opening your study at your selected sites.
We understand how important it is to open sites quickly and commence recruitment. One of the ways we can support this is by using our national Network structure to enable collaborative working across all your sites.
We will provide the mechanism for your sites to share their insights and successes to overcome challenges during study set-up and delivery. We like to think of it as a ‘do once and share’ approach; a way of identifying obstacles and sharing solutions to help multiple sites open as quickly and efficiently as possible.
Get started: Schedule your study start-up call
For each participating site you will have a contact in the local Clinical Research Networks (CRN) or devolved administration equivalent. Your lead CRN - the region where your Chief Investigator is based - will invite you to a study-wide start-up call.
The purpose of this call is to initiate the conversation with all your sites. The study start-up call agenda will be tailored to your study and the outcomes will be shared to all your study sites.
Your invitation to your study start-up call will be emailed when you have your approvals in place. To access this support simply accept your email invite offering your study start-up call (or video call).
How we monitor study progress: The Sponsor Engagement Tool
Visibility of real-time research activity data helps us to understand and utilise all the capacity in the health research system to deliver research quickly and efficiently. To achieve this we need a complete view of all the research taking place, so it is crucial that we collect data on study milestones and targets from all study sponsors.
Our Sponsor Engagement Tool enables sponsors (and their delegates) to provide regular assessments of study progress and ensure the data we hold is up-to-date. If your study appears to be behind schedule, we will seek to understand why. Support on how to access and use the Sponsor Engagement Tool will be available to you when your study is live.
What happens if I decide not to use the support described here?
The support and activities described on this page will help you to ensure your study is delivered within planned timescales. In the UK, new measures have been introduced which improve visibility of studies that are not progressing to planned timelines and potentially holding up the flow of research opportunities to patients. If study data is not adequately maintained NIHR research delivery issues may not be identified and resolved and NIHR support could be withdrawn. This is to enable our research delivery resources to be redirected to support studies that are deliverable and to ensure that we can continue to provide patients with opportunities to participate in research.
Further information
You may find our 10-step user guide for our Study Support Service helpful.
For further assistance you can contact your local or lead site support team.
If you are not sure who to contact email our Study Support Service Helpdesk for advice: supportmystudy@nihr.ac.uk
Related information
This is part of a suite of services that are collectively known as theNIHR Study Support Service. It is just one of the many ways we work with life science organisations to help you to plan and deliver research in the UK. Visit our NIHR support for industry page to discover our full range of support. You may also be interested in:
- Explore all our services and support
- Read useful articles and guides on delivering health research in the UK
- View our spotlights on UK strengths
- View case studies of our support for industry
Contact us
If you are new to the NIHR or not sure where to begin, fill out our simple contact form to request a chat with our Industry team. We aim to reply as soon as possible and always within two business days.