Fionnuala is a clinical strategy specialist with more than 25 years’ experience working with multinational biopharmaceutical, indigenous and high potential start-up medical device, diagnostic and pharmaceutical companies. She established Empirical Clinical Solutions in 2019 with a vision to supporting new medical technologies and pharmaceuticals to meet rigorous regulatory requirements.
Fionnuala provides clinical strategy advice and flexible support services from the early stages of product development to help limit costs, produce measurable clinical evidence and achieve regulatory approval. She is an advisor on EU Regulations for Medical Devices 2017/745, and ISO Standard and a trainer for ICH-GCP/ISO14155 and EU MDR 2017/745. With a detailed understanding of research infrastructure in Ireland, extensive therapeutic experience and impressive commercial acumen, Fionnuala is uniquely positioned to develop and deliver best practice across all phases of clinical studies in alignment with ICH-GCP, GCP Medical Devices, FDA, ISO and EU clinical trial regulations.
Fionnuala is passionate about cutting-edge technologies and components that fulfil unmet medical needs and improve quality of life. She is also a devoted patient advocate committed to safety, traceability and transparency in clinical studies and bringing medical technologies to market that are safe to use, perform as intended and operated by comprehensively trained operators.
Fionnuala holds a MSc in Pharmaceutical Medicine from Trinity College Dublin. Her experience as Registered General Nurse also supports her blended perspective on advanced medical treatments, healthcare outcomes and patient advocacy.