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-UCC 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. The Quality and Regulatory Department consists of
- Director of Quality and Regulatory Affairs,
- Two study monitors,
- Senior Pharmacovigilance officer
- Quality officer
Our staff are available to assist commercial partners by:
Monitoring: 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. Remote monitoring can also be carried out by our monitors. We monitor both HPRA regulated IMP trials and device investigations and other interventional (e.g. food, exercise) and observational studies across all therapeutic areas.
Audits and Quality Reviews: Our experienced auditor (Dr Ruben Keane) can carry out Sponsor audits or Quality reviews on Clinical Trials and Clinical Investigations to assure compliance with ICH-GCP, ISO14155 and other applicable regulations and guidelines. Process audits can also be undertaken.
For further information about HRB CRF-UCC Monitoring, Audit and Quality review service, please contact Dr. Ruben Keane, Director of Quality and Regulatory Affairs.ENQUIRE