Brigid Flanagan

Brigid Flanagan is the founder and Managing Director of Oriel Research Services. She has an undergraduate degree in Sociology from Trinity College, Dublin, trained as a registered nurse in the United Kingdom, and completed a Master of Science degree in Bioethics at Union Graduate College/Mount Sinai School of Medicine in New York, USA.

She has extensive therapeutic experience gained at hospitals in the UK and in the NY metropolitan area. Her first exposure to clinical trials was as a research coordinator for sepsis trials in the ICU at Long Island Jewish Medical Centre (now part of the Northwell Health System). She subsequently led clinical operations at the Biomedical Research Alliance of New York, an academic alliance, founded in 1998.

In 2003 she joined Fresenius Medical Care in Waltham, MA, as the US National Research Coordinator. Subsequent roles resulted in increasing levels of responsibility and oversight of multi-site Phase 1 to Phase IV studies, as well as device studies, for this large health care company.

In 2010, she launched a niche nephrology CRO within the clinical studies division at Fresenius Medical Care North America. She staffed and developed project, monitoring, and vendor management teams which resulted in increased revenue and a reputation as a service provider that was responsive, collaborative and, above all, willing to go the extra mile to get the job done. In 2014 the CRO arm at Fresenius Medical Care was re-branded as Frenova Renal Research.

In 2017 she relocated to Ireland. She continues to provide support as a clinical operations consultant to clients across the world by focusing on their quality management systems, facilitating workshops to evaluate protocols for potential risks, encouraging the adoption of quality by design (QbD), and ensuring study teams have processes in place to actively manage risk throughout the lifecycle of the trial and, where applicable, comply with the requirements of the European Clinical Trial Regulation 536/2104.

Brigid obtained professional certification as a Certified Clinical Research Coordinator (CCRC) from the Association of Clinical Research Professionals (ACRP) in 1998 and remained actively involved in that organization for many years. She has presented at industry conferences such as ACRP, MAGI and SCOPE, is a member of the Research Quality Association (RQA) and leads the Site Quality Leadership Advisory Board at WCG Avoca Quality Consortium ®.