Study Support Service - Supporting CROs

Last financial year we supported 113 different Clinical Research Organisations (CROs) to conduct 850 clinical studies in the NHS. You might be surprised to hear that this equates to just over half of the NIHR Clinical Research Network's commercial portfolio of research.

The NIHR Clinical Research Network supports CROs to set-up and deliver clinical research in the NHS, across all therapeutic areas, in exactly the same way that we support life science companies. These services include:

• personalised advice about the different support available
• access to NHS clinical experts across all therapeutic specialties to advise on the feasibility and compatibility of a clinical study with NHS care pathways
• a national, streamlined site identification service which enables companies to rapidly receive expressions of interest from potential investigators from over 240 NHS organisations and 10,000+ General Practices in England
• a site intelligence service which utilises local site and study data to sense check recruitment targets and identify competing studies
• a streamlined study set-up process to help multiple sites set-up quickly and effectively including access to costing tools and model contracts
• proactive study-wide performance monitoring to help ensure studies to meet their recruitment targets within planned timescales.

The case studies below shine a light on our Site Identification Service, which forms part of the feasibility services offered through the NIHR Study Support Service.

Tailored Clinical Research Solutions (TCRS) is a UK-based CRO with a global reach. TCRS was bidding for two studies with the same sponsor; one in schizophrenia, the other in refractory schizophrenia. Both studies were investigating the safety and efficacy of an investigational medicinal product for the treatment of schizophrenia symptoms.

As part of the bid, TCRS was required to submit a list of potential sites that had indicated an interest in the studies. TCRS had already identified approximately half of the total number of potential sites required, but needed help identifying the other half which amounted to a further 10 sites. TCRS had an extremely tight deadline of four working days to identify the remaining sites and approached the NIHR Study Support Service for help. Normally companies are advised to allow 15 working days for the full Site Identification Service to return results. However, as information on the study was limited and the deadline so close, the Study Support Service team offered to undertake a lighter touch version of the Site Identification service.

 Within four days the Site Identification service returned 31 sites that had expressed interest in the two studies. As a result TCRS was able to complete its bid and subsequently won part of the contract to conduct feasibility for the study.

 “The Network team responded with a list of sites for our study, and potential investigators within just four days. Based on that information, we won part of the contract to conduct feasibility for the study. Once that is done, fingers crossed it will progress to a full study. So the bottom line is, thank you, thank you and thank you. When we have our next proposal, we will definitely use the NIHR Study Support Service again.” 

Dr Davy Yeung | Managing Director, Tailored Clinical Research Solutions Ltd

Aqua Clinical is a UK-based boutique CRO that specialises in study start-up. Aqua Clinical accessed the NIHR Study Support Service to help find sites for a Swedish company that was planning an observational dermatology study evaluating a cream or ointment for dry skin conditions such as eczema.

Delivery of the study requires the treating physician to complete a questionnaire in conjunction with patients whose ages range from infants to adults. The study is quite challenging in that it needs to fully engage 260 patients within a three month recruitment window. In reality, this means aiming to recruit approximately 500 patients, to allow for drop-outs and incomplete questionnaires.

Through the CRO, the company hoped to gain expressions of interest from a minimum of five sites which could reach approximately 100 patients each, and was open to both primary and secondary care submissions. However, the company was working to a tight deadline and the CRO had just 11 working days to obtain the minimum number of interested sites.

As stated above, normally companies are advised to allow 15 working days for the full Site Identification Service to return results. However, the NIHR Site Identification successfully returned 15 sites within the 11 working days.

 “Despite the deadline for getting expressions of interest being extremely tight, the results were phenomenal. Working with the NIHR Study Support Service really relieves a lot of pressure and opens many doors as sites respond much faster to the Study Support Service Team, than they do to an email they don’t recognise. The Study Support Service team was also very flexible and, as well as rapidly finding the sites, they agreed to flag them to us as the responses came in, rather than submit them all in one go. This meant that we could begin review the submissions to identify the best sites to put forward and ensure we made the sponsor’s deadline. It was well executed and I’m 99 per cent certain this study will go ahead.”

Jay Tatla, Regulatory Consultant, Aqua Clinical