Improve the quality of your clinical study results.
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Audit objectives:
A GCP Audit with a strategic approach to your clinical trials, besides to available safety of subjects and the data generate, will be gather value to auditees to demonstrate opportunities for improvement and to mitigate risks.
Customer Demand:
The entire process takes place according to the main focus of each audit and customer needs and as agreed in meetings.
Such as:
A quality audit is flexibly structured according to your needs to run a gather value audit program.
A specialized team that will provide diligence, security, and experience in analyzing potential risks for your clinical trial.
In an audit strategy for technical objectives, quality and business objectives aligned with the client's objectives.
Work together with all stakeholders to achieve excellence in generating quality data and subjects safety with a collaborative approach.
Summary of qualifications and experience
Caroline Nanzer has a Bachelor's degree in Biomedicine and a post-graduate degree in Clinical Research. She has been involved in clinical research since 2011, working in various roles in Clinical Research Sites, including their structuring, quality assurance, project management, and team leadership.
She became the top global recruiter for clinical studies with high-quality generated data, founded her own Clinical Research Site, served as a reporting member of an Independent Ethics Committee (IEC), and worked as a quality specialist in clinical research in the pharmaceutical industry.
Since 2020, she has been working exclusively as an independent consultant for international companies in the USA, Italy, France, Canada, Switzerland, Hungary, and Germany, conducting GCP, GCLP, Bioequivalence audits in Brazil and Latin America.
Caroline Nanzer is a GxP auditor and a member of the Society of Quality Assurance (SQA) and other professional societies.
Testimonials
What our customers write about us
Caroline Nanzer helped us with a GCP audit for COVID-19 Study to pre-inspection. Your findings were extremely correct and with potential risks associated that contributed to the improvement of the Study and Quality of the Site until other Studies with us.
I needed the services of Nanzer for a GCP audit, and She was amazing to detect the issues, thus, the CAPA was completed with success, and the Site could to mitigated the risks assessment with her instructions and applied improvements. She was punctual in the process, according to our SOP and protocol, and had great communication with the Site and us Sponsor.
I really appreciated your commitment and hard and thorough work, so for sure we will contact you for future work.
Get in Touch with Us
We appreciate your interest in our services.
If you would like to learn more about our services or receive a free assessment, please fill out the contact form or contact by:
email: suporte@carolinenanzer.com.br
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