Industrial & Commercial Partners

Industrial & Commercial Partners

The CRF-C is equipped to work in partnership with industry and provide the infrastructure, facilities and experienced research and specialist support staff to successfully conduct world-class patient-focused research. The CRF-C supports researchers and companies in both the pharmaceutical and medical technologies sectors in developing and delivering cutting edge research in a safe and regulated environment to international standards. 

We provide a range of services that are designed to improve the performance of research and help the delivery of studies, particularly large and multi-centre studies, on time and to target. These services are outlined below.

The CRF-C provides an Advisory and Consultation service for Industrial and commercial partners.

The CRF-C is equipped to work in partnership with industry and provide the infrastructure, facilities and experienced research and specialist support staff to successfully conduct world-class patient-focused research. We provide a range of services that are designed to improve the performance of research and help the delivery of studies, particularly large and multi-centre studies, on time and to target.

The CRF-C supports researchers and companies in both the pharmaceutical and medical technologies sectors in developing and delivering cutting edge research in a safe and regulated environment to international standards. We provide consultancy, support and information services to both academic groups and life sciences companies on product development and clinical strategy process from concept to commercialisation. This includes facilitation of contacts for companies/researchers with the clinical community and service providers required to support the development of their project.

Please contact Maeve Kelsey, Clinical Research Nurse Manager 

The CRF-C provides a Study Feasibility service.

Study feasibility is a process through which a clinical trial sponsor (or representative e.g. Clinical Research Organisations) identifies potential investigator sites and evaluates if they are suitable to conduct the clinical trial. The CRF-C Study Feasibility service is coordinated through a dedicated feasibility coordinator who navigates local systems and engages with potential investigators, leading to efficient and timely decisions regarding the feasibility of all the hospitals affiliated with the CRF-C as sites for a clinical trial or clinical investigation.

The Clinical Research Facility at UCC is also part of the HRB CRCI National Study Feasibility Programme. This national programme connects academic and industry sponsors with potential investigators. HRB CRCI act as the channel through which study feasibility assessments can be distributed and completed efficiently. 

Please contact Maeve Kelsey, Clinical Research Nurse Manager 

The CRF-C Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the CRF is conducted to the highest standards.  The Quality and Regulatory Department currently consists of the Quality and Regulatory Affairs Manager, a Pharmacovigilance Officer, a Monitor and a Quality Executive Assistant.

Our staff are available to assist Investigators and study staff by:

Quality

  • Monitoring:  A dedicated, trained Monitor is available to carry out a full range of monitoring activities including site initiation, ongoing clinical activity monitoring, drug accountability and site close out for Health Products Regulatory Authority (HPRA) regulated and non-regulated trials.
  • GCP Training: ICH-Good Clinical Practice (GCP) training is provided for Investigators and study site personnel
  • Other Training: Other training services are avaialable to both the Principal Investigators and study site personnel as requested: e.g. Pharmacovigilance, Study Documentation etc.
  • Audits / Quality Reviews: Sponsors and Investigators can request uality reviews and audits of studies to ensure compliance with national and international legislation and guidelines.
  • Pre Study Audit: Review of study documentation (Investigator Site file) before site initiation.

Regulatory Affairs

  • Study Planning: Providing advice on prospective studies /trials to PI and study site personnel at study set up.
  • Regulatory Planning: Interacting with HPRA to seek advice on behalf of PI re prospective study/ trial.
  • HPRA Approval: Submitting Clinical Trial Applications to HPRA on behalf of PI.
  • Ethics Committee Approval: Submitting Application to Research Ethics Committees  (REC) on behalf of PI for Clinical Trials and studies.
  • Amendments: Submitting study/ trial amendments to HPRA and REC.

Please contact: Dr Ruben Keane : Quality and Regulatory Affairs Manager

The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the CRF is conducted to the highest standards.  The Quality and Regulatory Department currently consists of the Quality and Regulatory Affairs Manager, a Pharmacovigilance Officer, aMonitor and a Quality Executive Assistant.

Our staff are available to assist Investigators and study staff by:

Quality

  • Monitoring:  A dedicated, trained Monitor is available to carry out a full range of monitoring activities including site initiation, ongoing clinical activity monitoring, drug accountability and site close out for Health Products Regulatory Authority (HPRA) regulated and non-regulated trials.
  • GCP Training: ICH-Good Clinical Practice (GCP) training is provided for Investigators and study site personnel
  • Other Training: Other training services are avaialable to both the Principal Investigators and study site personnel as requested: e.g. Pharmacovigilance, Study Documentation etc.
  • Audits / Quality Reviews: Sponsors and Investigators can request uality reviews and audits of studies to ensure compliance with national and international legislation and guidelines.
  • Pre Study Audit: Review of study documentation (Investigator Site file) before site initiation.

 Please contact: Dr Ruben Keane : Quality and Regulatory Affairs Manager

Pharmacovigilance / SAE processing for UCC sponsored studies.

The Quality and Regulatory Affairs Department carries out Serious Adverse Event (SAE) processing and pharmacovigilance activities for regulated clinical trials that are sponsored by University College Cork (UCC).

Services include:

  • Provision of a dedicated pharmacovigilance email, phone and fax for PIs to submit
  • Logging and filing of all SAEs for the study
  • SAE assessment by UCC Clinical Research Reporting Officer (CRRO (Sponsor Representative)).
  • Submission of Suspected Unexpected Serious Adverse Reactions (SUSARs) to HPRA and REC within regulatory timelines. 
  • Assisting PI with Development Safety Update Report (DSUR) preparation and submission to HPRA and REC.
  • Ongoing risk/ benefit monitoring– in conjunction with the PI. 

Please contact: Dr Ruben Keane : Quality and Regulatory Affairs Manager

The CRF-C provide the necessary supports to optimise study start-up activities, including central coordination and dedicated resources. These supports accelerate all aspects of the study start up process at the site level including facilitating:

  • Contract approvals
  • Clinical Trial Insurance approvals
  • Financial set up, etc.

Please contact Maeve Kelsey, Clinical Research Nurse Manager 

Clinical Research Nurses

CRF-C research nurses provide high quality nursing services across a broad range of therapeutic areas. The nurses provide dedicated research support for the delivery and conduct of studies whilst providing nursing care in the management of research participants.

The nurses collaborate and liaise effectively with Principal Investigators, Sponsors, affiliated research staff and external vendors in ensuring that protocol procedures are implemented with meticulous attention to ICH GCP, CRF-C SOPS and CRF-C working procedures.

Responsibilities

The research nurses have a central role in:

  • Feasibility studies
  • Protocol implementation
  • Study conduct and coordination
  • Investigator site file management
  • Assuring participant safety
  • Patient recruitment and retention
  • Randomisation procedures
  • Data collection and entry into CRF
  • Follow up procedures
  • IMP management

Clinical Research Assistants (CRA) Support

Our team of Clinical Research Assistants (CRA) work under the supervision of the Research Nurses and Principal Investigators. They are a flexible delivery team who are able to assist with data collection and data management, as well as providing clinical and recruitment support.

Clinical Trials Physician

The CRF-C also employs a dedicated Clinical Trials physician. They play an important role in obtaining patient informed consent in a timely manner and thus ensuring efficient patient recruitment processes. They are also play an important role in carrying out AE/SAE review and carrying out routine study procedures.

Who to contact?

Nursing and Clinical enquires for CRF –C should be directed to the Research Nurse Manager Maeve Kelsey

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