NAVIFY Decision Support Portfolio

Background

As a Regulatory Affairs Specialist at Roche, I supported the design and development of 11 clinical decision support software products by creating international regulatory strategies in collaboration with product, engineering, design, quality, and compliance. I also authored, reviewed, and approved design history file documents including intended use statements, requirements, risk analyses, and instructions for use. I contributed to 4 releases in 2019, 31 releases in 2020, and 20 releases in 2021 for products currently launched in 22 countries.

Some products I worked on include:

• NAVIFY Tumor Board is a cloud-based workflow product that securely integrates and displays relevant aggregated data into a single, holistic patient dashboard for oncology care teams.
• NAVIFY Guidelines assists decision-making with access to the most recent NCCN Guidelines. It allows for a faster and easier way to review up-to-date clinical guidelines to support evidence-based diagnostic and treatment decisions.
• NAVIFY Clinical Trial Match increases treatment options by identifying clinical trials relevant to individual patients.
• NAVIFY Publication Search supports treatment decisions with the latest medical and scientific literature.
• NAVIFY Oncology Hub is a clinical workflow and decision support product that provides a holistic overview of patients' cancer care journey.