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Overview

The HRB 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 HRB 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.


Clinical Research Facilities & infrastructure

The HRB CRF-C provides the infrastructure, facilities and experienced research and specialist support staff to successfully conduct world-class patient-focused research.

Study Feasibility Service

The HRB CRF-C provides a Study Feasibility service and the necessary supports to optimise study start-up activities. The HRB 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.

Clinical Operations Staff

The HRB CRF-C Clinical Operations team consists of experienced clinical research professionals who work individually and as part of a multidisciplinary team in delivering high quality research to target, on time and within budget.

Regulatory Affairs

The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the HRB CRF is conducted to the highest standards. The HRB CRF-C operates in accordance with a fully regulatory compliant Quality Management System and provides the full suite of Quality and Regulatory services required to support world class patient focused research.

Clinical Trial Monitoring and Audit

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. Dedicated, trained monitors are available to carry out the full range of on-site monitoring activities including site initiation, ongoing monitoring and site close out.

Pharmacovigilance

The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the HRB CRF-C is conducted to the highest standards. Our dedicated Pharmacovigilance staff can provide a full pharmacovigilance service for your Clinical Trial/ Clinical Investigation.

ICH GCP Training Courses

The Quality and Regulatory Department helps to ensure that patient focused research undertaken under the supervision of the HRB CRF is conducted to the highest standards. Our team of experienced clinical research professionals regularly deliver ICH-GCP Training to investigators and study site staff, both initial GCP training (4.5 hours) and refresher GCP course (2.5 hours).

Statistics & Data Analysis Unit

The Statistics and Data Analysis Unit at the HRB CRF-C provide statistical support to clinical investigators and industry partners, at all stages of the research process. We operate under a quality control system suitable for regulated studies, and use open science workflows that promote research integrity.

Clinical Trials Project Management

The HRB CRF-C provide Clinical Trials Project Management expertise to ensure that patient focused research projects sponsored by industry partners are successfully concluded on time and budget.

Clinical Trial Design And Methodology

The Clinical Research Facility at UCC provides an advisory and consultation service for Industry collaborators (typically SME’s) and Clinical Investigators who wish to carry out patient focused research. The HRB CRF-C can provide guidance on questions relating to study design and conduct.

Study Start-Up Service

The HRB CRF-C provide the necessary supports to optimise study start-up activities, for both regulated clinical trials and other collaborations with commercial partners, including central coordination and dedicated resources. These supports accelerate all aspects of the study start up process at the site level.