Your clinical development strategy is a detailed roadmap that underpins the clinical development process.

Client Testimonials

“At the Wellington Eye Clinic, we are involved with several research projects from Europe and the USA and are often in need of serious expertise when initiating these studies. Fionnuala has excelled in this regard and always given us sage advice. Fionnuala also did onsite training with our team on ISO14155 (Clinical investigation of medical devices for human subjects — Good clinical practice) which was excellent. We have enjoyed her support and advice on a number of projects: A first-in-man study was performed using a new UV-femtosecond laser and Fionnuala modified the protocol to gain acceptance from the HPRA yet keep the FDA happy. With yet another study we were advised to list the device being studied in a different category and this led to approval as well as an ultimately more appropriate classification for the device. I, along with the rest of the research team at the Wellington Eye Clinic, can wholeheartedly endorse and recommend Fionnuala’s services.”

Arthur Cummings, Medical Director

Wellington Eye Clinic, Dublin

“Effective clinical trial planning requires a range of skill sets and experience spanning regulatory, clinical, design, user experience etc; it is very rare that Lifescience start-ups have all the required skill sets and experience as part of their founding team. Assuré Medical Limited engaged with Fionnuala Gibbons at Empirical Clinical Solutions to support the development of a clinical investigation plan for our medical device. Fionnuala supported us on the development of our Clinical Development Strategy as there were key elements to be completed in advance of developing a clinical study. If you are starting out on a Lifescience venture or already well progressed towards your clinical trial planning, you will probably save time and resources by engaging early with Empirical Clinical Solutions, which we found responsive and client focused throughout our engagement.”

Ger O’Keeffe, Assuré Medical Co-founder