“Have Confidence in Our Ethical Standards”

At BioIVT, we understand that you need biospecimens you can trust. I am just one of our team of over 23 Regulatory and Quality personnel, who have more than 250 years of combined experience to ensure that you can trust our specimens. We work with the industry’s leading central IRBs as well as local IRBs, UK/EU-based RECs, and Health Ministries globally to ensure the highest standard of governance and ethics. We also comply with various regulatory and licensing requirements, where applicable. Please visit our Quality & Regulatory Page for more information

My passion for clinical research and regulatory affairs can be traced back to 2011 in Central Florida, where I spent valuable time learning clinical trial operations and regulatory affairs from experts in clinical research. It was my pleasure and honor to be involved in some of the early human trials that led to current therapies in the cystic fibrosis disease space. Since that time, I have continued to gain valuable experience in clinical research best practices, regulatory practices such as IRB/REC review, site monitoring, and auditing, international research and data privacy. As a seasoned Head of Compliance & Regulatory Affairs and recent Data Protection Officer, I am passionate about continually advancing the operating standards at BioIVT in support of elevating science. In addition to daily operations concerning compliance and regulatory oversight, including data privacy, I am also involved in the due diligence and integration of new acquisitions from a regulatory perspective. Others and I on the Regulatory team avidly participate in monitoring new regulatory releases, amendments to existing regulations, and participate in best in practice training to continually raise the standard for how to ethically source biospecimens and ensure compliance with industry regulations. Our teams’ commitment to excellence is not only influencing the way BioIVT approaches sourcing biospecimens to provide to researchers, but also the industry. 

In my role as Head of Compliance & Regulatory Affairs and DPO, clients can expect:

• Excellence in regulatory oversight and guidance on clinical research best practice in all aspects including consent, data collection and storage, subject recruitment, site monitoring and auditing and IRB/REC oversight.
• Adherence to current regulations and highest ethical standards.
• Access to relevant ethical review documents including IRB/REC documents, consent form templates, etc. to meet client needs.