Elisabeth Scheidl Consulting
Escalate to Quality
By creation of efficient management systems for Clinical Trials including implementation of a robust process to ensure high quality and to manage potential compliance risks at your company.
Eschew Complication
By guidance and support for senior management to make robust decisions and respond to questions on QA and compliance related topics for your company.
Escape from Complexity
By creation and set-up of a new, or assessment of an already existing, QMS to ensure the most efficient and risk-based processes are in place meeting the exact needs and requirements of your company.
There are no detours or shortcuts to good quality, there is only the direct route to the destination!
ESC Elisabeth Scheidl Consulting provides tailor-made and flexible solutions for your quality and compliance management systems.
Over 20 years of experience in clinical research, operational activities and quality assurance.
Experience-based outlines and conceptual designs for a lean and practical quality management system that meets the requirements of daily practice and application.
Services
AT A GLANCE
What you get
- Over 20 years of experience
- Practical knowledge in operations and QA in R&D
- International & intercultural
Qualifications
- Degree in Life Science
- Graduate degree in Health Science
- Certified DPO acc. to GDPR
Assets
- Process-oriented & interdisciplinary
- Experience-based
- Practical
About
Extensive experience in auditing (more than 60 investigator site audits, approx. 60 vendor qualification audits, as well as document audits and internal system audits.
Broad knowledge of conduct of early phase clinical trials (phase I – II) including First-In-Human trials.
Successful creation and implementation of Quality Management and Compliance Management Systems for R&D departments in several companies.
Working in cross-cultural business relations and leading (remote) intercultural teams.
Elisabeth Scheidl is an expert in clinical research with many years of experience (since 2000). Her strong understanding of high-quality requirements and her ability to think in a process-oriented and interdisciplinary manner have led her to specialize professionally in the area of quality assurance and quality management. She has been working in quality assurance for 15 years now, the last few years in senior management positions.
For further information please contact me directly.