Basildon and Thurrock University Hospitals NHS Foundation Trust (BTUH) serves a local population of around 400,000. On average each year we treat 77,500 inpatients and day cases; provide nearly 300,000 outpatient consultations and tend to more than 103,000 accident and emergency patients.
The Trust is also home to The Essex Cardiothoracic Centre (CTC), which offers specialist cardiology, cardiovascular and thoracic services to the population of Essex, Hertfordshire and North London. The CTC has facilities for 100 patients and has capacity to perform 1400 surgical procedures and 2500 cardiology procedures each year. The CTC boasts some of the most modern cardiovascular treatment facilities in the country, offering 24/7 primary percutaneous coronary intervention (PPCI).
The Trust is committed to supporting high quality commercial research, and hosts and sponsors a large number of commercial and grant funded studies across all our clinical divisions including from pharmaceutical and medical device industries.
Industry, commercial companies, sponsors and contract research organisations (CROs) wishing to undertake commercial research at our sites should contact our research and development department as early as possible to discuss their needs.
We are keen to collaborate with industry from outside the UK and can provide advice and guidance on obtaining ethics, local permissions, UK legislation and have acted as sponsor and CRO for single site and multi-centre studies.
Ashley Solieri, associate director of R&D is the Trust signatory for research contracts and NHS Permissions.
We use the suite of NIHR model agreements that have been developed nationally in the UK with the Association of the British Pharmaceutical Industry (ABPI) and Association of British Healthcare Industries (ABHI). The use of these model agreements in unmodified form (with the exception of the addition of the site and study specific information) can lead to a quicker negotiation process. The use of modified model agreements or sponsor's own agreement templates may result in longer set-up times and legal review charges which will need to be met by the sponsor.
A brief description of each contract is given below.
1. model Clinical Trial Agreement (mCTA) for pharmaceutical research
For pharmaceutical industry-funded studies run in the NHS.
2. Contract Research Organisation model Clinical Trial Agreement (CRO mCTA) for pharmaceutical research
A tripartite agreement between pharmaceutical industry, NHS and CRO where the management of the clinical trial is outsourced by the Sponsor to a CRO.
3. model Clinical Investigation Agreement (mCIA) for medical technology industry
For medical technology industry-funded studies run in the NHS.
4. Contract Research Organisations model Clinical Investigation Agreement (CRO mCIA) for medical technology industry
A tripartite agreement between non-pharmaceutical industry, NHS and CRO where the management of the trial is outsourced by the Sponsor to a CRO.
5. model Industry Collaborative Research Agreement (mICRA)
A tripartite agreement between industry, NHS and University.
We also advocate that industry use the NIHR Industry Costing Templates to cost all industry sponsored research. The template should usually be completed by the Sponsor/CRO in the first instance and then sent to sites for review and to initiate the negotiation process. There are templates for both pharmaceutical and medical device studies, but these are also used to cost non-interventional studies by just completing the relevant tabs.
The latest NIHR Industry Costing Templates can be found on the NIHR.
If you are a member of Trust staffand have been approached to take part in a commercial study or you have an interest in getting involved in industry-led research, please contact the research and development department for further information and assistance.