Our Services
The GMLC team offer a range of research related support to local clinical teams running studies, and also help study sponsors and co-ordinators. In most cases, GMLC staff will assist with initial phases and setup of a study and will support staff funded by the study (e.g. by training them or providing advice etc). There will be some instances where network staff are funded by the study itself to actually manage the project from start to finish.
We aim to help local sites get off the ground more quickly, and offer expert support on getting through all the red tape and paperwork associated with research in the NHS.
Training & education
GMLC can deliver training and provide advice and support on any aspect of study management. More details can be found here.
Feasibility
The network assists study sponsors (e.g. pharmaceutical industry) in identifying local sites who may be interested in future trials. This includes helping to provide data on patient populations and information on current NHS practice. Download this leaflet for further information.
Study proposal development
GMLC works with MCRN Clinical Study Groups, local Research Design Units and R&D Offices to help researchers develop their ideas into funded proposals that ultimately may be adopted by the MCRN. More information on developing proposals can be found here. For researchers working in CMFT, a flowchart for developing a study can be found here
Feasibility of study at site
GMLC staff will help local investigators understand the practical implications of running a study at their site and will assist them with any potential difficulties.
Approvals and agreements
Our team are well versed in the local requirements of R&D Offices and Research Ethics Committees and can put together submissions for both on behalf of the local site. Our staff also deal with contracts and other agreements that may be required and will make sure they are in place before the study starts.
Costings
With the phased withdrawal of the R&D levy from NHS Trusts, costing research has become an important research related activity. Our staff can help to calculate the cost of running the project at a site and check to ensure funding is in place to cover all costs. This is done in conjunction with the investigator, local R&D and the sponsor.
Investigational Medicinal Product management
A key member of the GMLC team is our Network Pharmacist. Their role is to assist with the IMP management of all MCRN studies at the Manchester Children’s Hospitals and also to provide advice and support to other pharmacy departments in our region.
Study set up & initiation
Our team can also help with the practical measures and planning that must take place before a study can start at a site. This includes helping ensure support services such as laboratories and radiology are ready to take part, or setting up an initiation meeting. Help can also be provided in setting up regulatory compliant systems and processes, such as Standard Operating Procedures.
Support of local study staff
The network can help with the recruitment of study staff funded by the trial and also with their induction and training. This also applies to staff who may already be in post locally, and training can be provided throughout the duration of the study.
Patient recruitment
The team can also help with planning successful recruitment strategies to maximise accrual.
Data collection & input
Training and advice on collection, recording, managing and storing data in accordance with governance requirements is also available.
Study close-down and archiving
Once the study has ended, we can help to ensure it is closed down correctly and that archiving arrangements are in place and compliant with the regulations governing trials.
