About
Founder of BIOXELA · More than 25 years of experience in clinical research
The company
BIOXELA was founded on 18 November 2025. The company provides guidance to pharmaceutical companies, biotech firms, service providers, MedTech companies, healthcare institutions (hospitals, clinics), and private practitioners.
Alexandra TIZON — Founder
Senior Clinical Operations Project Manager · External DPO
Alexandra TIZON began her career as a Clinical Research Associate (CRA) for 8 years, building solid hands-on experience across various types of healthcare organisations. She then progressed to Senior Clinical Project Manager roles, overseeing Phases I to III interventional and non-interventional drug studies. Her experience also enables her to manage combined drug and medical device trials. Alongside her clinical career, she has specialised in personal data protection since 2006. Since 2018, she has worked in several biotech companies on GDPR compliance for their clinical studies. With more than 25 years of experience in clinical development, she founded BIOXELA in 2025 to bring this dual expertise to her clients.
Core skills
- Global Clinical Project Management (Phases I–III, non-interventional studies, IITs)
- Cross-functional leadership with international teams
- CRO / vendor oversight, financial excellence
- EMA (CTA/CTIS/IRIS, Eudravigilance) and FDA (pre-IND, IND) regulatory submissions
- Risk management and mitigation strategies
- TMF / eTMF set-up, Quality Control, and archiving
- Inspection readiness
- ICH-GCP, GDPR, cybersecurity, anti-gift law
The full details of Alexandra TIZON's professional background are available in her CV: Download CV (PDF)