Regulatory and Clinical Expert
Prior joining Qserve, Abigail worked on the medical device industry as a Clinical and Scientific Affairs Manager, where she developed clinical strategies and delivered evidence to optimize product life-cycle, building and managing effective partnerships and ways of working within and across different businesses.
She developed multiple study protocols, planning, designing, conducting and reporting clinical trials. She provided strategic input on regulatory submissions, clinical evaluations, support of complaint report determinations and health risk assessments.
Abigail holds a BSc in Electronic Engineering, focusing on Image Processing and she has a PhD in Biomedical Engineering. Her main area of research has transitioned to bio mechanics and how different conditions and environments may alter the way we walk, by developing a multi-segment foot model fitted by data collected on clinical trials
The key expertise areas of Abigail:
- Clinical strategies and development plans
- Clinical evaluations
- Clinical trials along with study documentation
- Project management of clinical trials
- Develop collaborative relationships with KOLs, investigators and site staff
- Clinical input throughout the different stages of product development
Learn more about Qserve CRO