Industry
The MCRN works in close partnership with pharmaceutical, biotechnology, contract research organisation (CRO) and other companies to maximise the development of safe and effective medicines and formulations for children. The Network facilitiates company-sponsored and investigator-initiated (industry-funded) studies in NHS sites serving approximately 12 million children. For details of how the MCRN supports publicly-sponsored studies, please click here. We support therapeutic clinical trials and pharmacokinetic (PK), pharmacodynamic (PD), pharmacovigilance and other studies in all disease areas (except oncology and some mental health studies that are facilitated by other Networks; please contact MCRN for advice).
Please see the sections below and links from this page for information on:
- MCRN Industry Team contacts
- How can the MCRN assist my research?
- EU Paediatric Regulation, Protocol and Other Advice
- Feasibility (Site Identification)
- Qualifying for MCRN Support (Adoption into the NIHR CRN Portfolio)
- Site Setup
- Recruitment
- Closure
MCRN Industry Team
The MCRN Industry Team is responsible for ensuring that the pharmaceutical/biotech industry can conduct studies effectively across the Network.
The team members are:
- Dr Susan Tansey (MCRN Associate Director - Industry Lead)
- Ms Carla Owen (MCRN Industry Manager)
- Dr Andrew Rose (MCRN Deputy Assistant Director)
- Dr Sabah Attar (MCRN Network Lead)
- Mr Chris Walsh (MCRN Network Delivery Officer)
If you have any questions about the support that the MCRN offers companies, please read the sections below, email This e-mail address is being protected from spambots. You need JavaScript enabled to view it or telephone +44 (0)151 282 4703 or +44 (0)151 252 5435.
How can the MCRN assist my company?
The MCRN supports pharmaceutical/biotech companies and CROs in a number of ways through its world-class infrastructure, which includes the MCRN Coordinating Centre, Clinical Studies Groups (CSGs), Local Research Networks (LRNs) and a Neonatal Network. (CSGs are groups of key opinion leaders that provide advice, identify research priorities and design protocols to address these priorities. LRNs and the Neonatal Network facilitate the conduct of studies across the NHS). Where appropriate, our interactions with companies are co-ordinated with Clinical Research Facilities (CRFs), medicines for children networks in Scotland, Northern Ireland and Wales and other NIHR CRN Topic Specific Research Networks. The MCRN can support companies through all research stages, as outlined below. For details of studies that MCRN is supporting already, please see click here. The MCRN also works with the CCRN Paediatrics (non-medicines) Speciality Group to support studies not involving medicines.
EU Paediatric Regulation, Protocol and Other Advice
MCRN CSGs and other staff can provide expert advice on the EU Paediatric Regulation/Paediatric Investigation Plans (PIPs) and the development of study protocols. Companies are advised to contact MCRN as early in the study/programme development cycle as possible. Advice can then be provided to give greater assurance on feasibility. Initial, limited advice is usually provided by CSGs without charge, but if more extensive advice is required by companies, the Network assists with the identification of relevant experts (contracting/financial arrangements typically made directly between companies and experts). The MCRN can also advise on formulations and on consumer matters, including the preparation of patient information sheets. (Please click the following for information on the EU Paediatric Regulation and specialities covered by CSGs).
Feasibility (Site Identification)
The Network can work with companies to collect feasibility data from sites, if required. If the study protocol is finalised (near finalised), companies should complete the NIHR CRN Trials Adoption Process and Feasibility Assessment Submission form and the NIHR CRN Costing Template, subject to arranging NIHR CRN confidentiality agreements (CDAs). Following a top-level review of the study, the Network aims to return names/contact details of interested investigators (with an initial indication of numbers of patients that can be recruited) within 10 working days. If study protocols are not finalised, MCRN can still identify study sites, but please contact the MCRN Industry Team for advice.
Following site identification, companies typically (1) arrange company-specific CDAs, (2) circulate full protocols, and (3) collect additional feasibility information from investigators/sites that can recruit sufficient numbers of patients. All correspondence to sites should be copied to the Network staff assigned to the study. Upon site/country selection, companies should inform the MCRN Coordinating Centre.
Qualifying for MCRN Support (Adoption into the NIHR CRN Portfolio)
If feasible, industry studies have to be adopted into the NIHR CRN portfolio to qualify for the support outlined below. Companies submit the study protocol and other information to the MCRN Study Assessment Committee, with the committee subsequently assessing the suitability of the study using the following criteria:
- Is the study well designed and of relevance to the NHS and its patients?
- Will the medicine/formulation under investigation provide a therapeutic benefit or meet an unmet therapeutic need?
- Does the MCRN have the current capacity to deliver the study efficiently and within budget?
The MCRN Study Assessment Committee meets every two weeks to consider studies so as to not delay study timelines. Responses are returned to study sponsors as soon as possible following meetings. Where studies have not been immediately adopted, detailed comments/requests for clarification are returned. Companies then return their own responses to the MCRN and these are either considered at the next Study Assessment Committee meeting or earlier by Chair’s action.
Site Setup
The MCRN assists with study setup following site/country selection and adoption to the Network’s portfolio of studies. MCRN staff work with companies and sites to assist:
- Costing: staff can calculate/identify R&D, laboratory, pharmacy and other costs. The Network expects the NIHR CRN costing template too be used, with companies initially estimating staff time required per patient and estimations being confirmed by appropriate local departments. (Click here to view NIHR CRN costing template).
- Local ethics and R&D approvals: The MCRN expects the “NIHR Coordinated System for gaining NHS Permission” (NIHR CSP) to be used to accelerate the NHS R&D approvals process.
- Contracting: staff can help local R&D Departments to arrange study contracts (i.e. the model Clinical Trial Agreement; mCTA).
- Training: All staff (commercial/NHS/academic) associated with adopted studies qualify for free NIHR CRN/MCRN training, including GCP courses.
Recruitment
Following site setup, MCRN staff work with companies and sites to ensure that adopted studies are conducted rapidly to a high standard, in particular focusing on:
- Recruitment: staff help the recruitment of patients by providing support to site staff, including advice on recruitment strategies. The NIHR CRN portfolio database is used to monitor recruitment rates closely to ensure targets are met.
- Research nurse support: Local site nurses typically assist with study procedures, but in some cases, Network-based nurses may be available to perform roles, subject to existing demands on their schedules.
- Data collection: staff can help with form completion/data submissions.
- Site support: If recruitment rates are below expectations, staff work with sites to identify and resolve constraints.
- New site identification: During recruitment stages, staff can identify additional study sites, if required.
Closure
Upon closure of the study, staff work with companies and sites to ensure that all regulatory and other requirements are addressed.
Questions?
If you have any questions about the support that the MCRN offers companies, please email This e-mail address is being protected from spambots. You need JavaScript enabled to view it or telephone +44 (0)151 282 4703 or +44 (0)151 252 5435.