About Empirical Clinical Solutions

Supporting medical device and pharmaceutical companies to navigate regulatory frameworks throughout the product lifecycle.

About Us

Empirical Clinical Solutions provides expert advice and support for medical device technologies and pharmaceutical companies that helps navigate regulatory frameworks, bring new products to market and deliver better patient outcomes.

We work with SMEs, multinationals and academic institutes to achieve CE Mark/FDA approval and market access for medical device technologies through the development of robust strategy, stringent protocols and high-quality clinical evidence.

As regulation around medical device technology intensifies, it is now more important than ever that product safety, efficacy, performance and the cost/benefit to healthcare organisations are supported by compelling clinical evidence. Empirical Clinical Solutions can help you understand how to meet the needs of regulators and achieve sustainable value throughout the product lifecycle.

We also work with pharmaceutical companies for program management, site monitoring and audit preparation. We also coach, mentor and train teams that contribute to capacity building. With the cost of drug development so high, it is critical that clinical processes are underpinned by rigorous protocols to achieve ethical, scientific and regulatory requirements. Our approach provides short to medium term support and gives our clients confidence in the veracity of their study outcomes.

Fionnuala Gibbons MSc
Clinical Director

About Fionnuala

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.