Site Nurse Support

In our Site Nurse Support service we place appropriately experienced & trained nurses and/or coordinators into sites to overcome resource constraints.  This service is flexible to meet with site requirements and can be anything from a day or two in total, to a regular number of days per month or even up to full time.  

Our staff, whilst financially contracted to the MRN, work on site as part of the Investigator’s team under their direction; each nurse/coordinator has their tasks delegated by the Investigator and documented as such and their CV gets filed as part of the trial documentation.

Enthusiastic research nurses & coordinators, knowledgeable in the protocol & therapy area, with time to spend talking to patients will always ensure the best enrolment – our service ensures this happens.

What can site support nurses do on site?

Our staff can cover all the roles and responsibilities expected of a research nurse or trial coordinator, including but not limited to:

• Database review & Identification of patients
• Pre-screening & Screening activities
• Manage patient schedules & clinics
• Patient assessment – safety and efficacy
• IXRS access and entry
• Investigator liaison
• Pharmacy liaison
• (e)CRF Completion & query management
• Drug management and administration
• Site file management
• Site paperwork and general administration

What about sites with limited trial experience?

All our research nurses & coordinators are selected according to the individual position, so where sites have little or no trial experience, we will ensure the individual placed is very experienced and can not only support the site, but also train and mentor them on the trial requirements.

All our nurses are fully trained in ICH GCP before they are placed on site and any study specific training is agreed with the Sponsor upfront.

We have experience of placing whole teams of nurses into limited experience sites, in fact sites who would otherwise have been rejected on trials, and ensured they have performed as well as or even better than the more experienced sites.

How do you approach boosting recruitment across multiple sites in a country?

We have recently introduced a Site Nurse Support team service, where we place a number of regionally based nurses within a country to travel around a local trial sites identifying and screening patients as required.  Often screening of patients is put off to later by site staff whose workload is high and needs to be managed carefully.  Putting our nurses in places removes this constraint as we shoulder the burden of the extra screening and enrollment activities, ensuring the maximum number of patients are randomized in the shortest time available.  If more patients than expected are subsequently enrolled (and we have seen this happen!), we can then ascertain what additional support may be required at that site and ensure it is secured.

Initiating this process right at the start of the trial to assess the greatest recruitment potential of sites can save valuable months in ascertaining the ‘real’ recruitment potential of a site. Feasibility studies are only a guide to what might be expected in sites, but once the trial is started our service can deliver detailed information about potential patients to be recruited.  Why wait 6, 9 or even 12 months to realize a site has no patients to offer?  Contingencies in this case need to be triggered as soon as possible!   
Such an approach can not only be deployed to boost recruitment, this approach also works in rescue situations, such as to catch up on CRF completion or query resolution.

Can you assist in the feasibility process?

We cannot place nurses on site before a full ethics approval is in place, but we can certainly advise on how to construct a feasibility survey; traditionally questions such as ‘how many patients do you see with a certain disease?’ and ‘how many patients could you recruit into this trial?’ do not necessarily address the recruitment need … questions such as ‘how many patients can you recruit per month based on your current resource?’ and ‘how many patients could you recruit if additional resource was available?’ may be more appropriate.  We can look at the protocols and challenges, as well as the time requirements and help to construct some meaningful questions.  Once the study starts our teams can rapidly confirm the recruitment potential of each site (see section above).