Delivered through Birmingham Health Partners and the Institute of Translational Medicine, the Research FIRST service supports non-CTIMP studies across a wide variety of methodologies and research areas.
Through engagement with other BHP research teams, focussed groupings and establishment of closer collaborations with existing partners, the Research FIRST service has the potential to drive cost savings and efficiencies for your project, and has the ability to engage and connect the business community via the ITM and its existing relationships with the Academic Health Sciences Network and the Healthcare Technologies Institute.
The primary aims of the Research FIRST service are:
- Increase collaborations with industry and other external partners – including external NHS Trusts and SMEs – by providing access to practical support in the delivery of projects via a streamlined approach that enables easy access to the expertise they require to progress their product
- Support independent investigators across Birmingham Health Partners and the wider research community in the delivery of their research by providing access to expertise such as research co-ordination, data management and database development
- Take a lead in bringing together the independent research community to support research quality and compliance – including the development and delivery of a training framework and the provision of senior research co-ordinator support
Why Research FIRST?
As non-CTIMPs do not fall under the regulatory remit of the Medicines and Healthcare Products Regulatory Agency (MHRA), many of these projects are not supported by clinical trials units (CTUs). As a result, many BHP Chief Investigators are left to carry out their studies with limited support. In addition, it can be challenging for small companies (SMEs) to access appropriate expertise, which can slow down or even prevent the development, validation and testing of their product.
The Research FIRST service is delivered by the core team based at the ITM, with direct access to clinical, academic and professional services support from across the BHP ecosystem.
We aim to provide a flexible service, tailored to the requirements of individual teams and/or projects. We can provide support in database development and maintenance, data management and research co-ordination, and have the flexibility to provide support for discrete elements of a project. This may include IRAS submission or database design, or taking responsibility for the delivery of an entire study. We can also support the delivery of larger strategic grants where programming or research co-ordination expertise is required.
We can support any studies that do not come under the remit of the MHRA, as any trials that require MHRA approvals are carried out within a CTU. We can support a variety of methodologies, from data-only projects and surveys, to testing the useability of a new devices (providing the device has already received its CE approvals and it is not being used off-label).
If you are unsure whether your project is CTIMP or not, we recommend the MHRA’s algorithm at Is it a clinical trial of a medicinal product? You are also welcome to contact us for advice by sending over your research study protocol.
Projects can come from any source, either within or outside BHP, and are not restricted to specific disease areas. Studies can be sponsored by a variety of sources (UoB; UHB; industry).
To ensure research quality, the Research FIRST team is developing a series of documents to provide clarity of responsibilities, compliance with sponsor requirements and appropriate training of staff. These will be available for download here as soon as they are available.
For discrete elements of a project, an estimation of the time required to complete will be made, and costs will be charged on a daily rate for the grade of staff required to carry out the task. These are based on the UoB staff daily rate and are dependent upon the funder (commercial funders, for example, will be charged at UoB commercial day rates).
Hosting of databases on ITM REDCap attracts a small annual charge that contributes to the cost of providing the servers and undertaking necessary database admin.
Costing of full project support is carried out in collaboration with relevant stakeholders (for example, finance or business engagement) and follows the standard costing process of the relevant institution.