Fellow Feature: Early Phase Clinical Trial Quality Assurance at Novartis

Every fellow has a different path to industry, and we like to feature their stories to showcase the diverse experiences our fellows bring to the program. This week’s article is written by Kaitlin Bova, a second year MCPHS University/Novartis fellow.

Kaitlin is part of Novartis’s new Quality Assurance (QA) program and was their first fellow. Even though QA is generally associated with a finished product, during the drug development process, there is always ongoing safety oversight at every stage. As mentioned in previous articles, all of the Novartis programs focus on early phase clinical trials, so Kaitlin has a unique perspective on QA. Read more to learn about what inspired her to pursue a fellowship in early phase quality assurance and what she’s most proud of from her first year!

After an internship with the Investigational Drug Service, I knew that I wanted to pursue a career in clinical research where I could work to bring medicines to patients who needed new treatment options. I discovered that I could most actively contribute to clinical research in the industry setting and chose a fellowship specifically in quality assurance because of my interest in protecting patient rights and designing safe processes and systems. I also find quality assurance interesting because it plays an important role in ensuring data integrity throughout clinical development, which allows patients and providers to have confidence in our medicines.

Through my fellowship, I have had the opportunity to deepen my understanding of drug development, especially early phase clinical trials, and the associated good clinical practice requirements (GCP).  Specifically I have been responsible for the following:

• Review and comment on essential documents associated with clinical trials ensuring compliance with standard operating procedures, and regulatory requirements
• Assist in quality control to support inspection readiness
• Participate in regulatory inspection preparation
• Assist with ICH/GCP training and promote quality culture
• Support deviation/audit root cause analysis and assist in the creation of clinical quality incident/investigation materials
• Assist in tracking quality operational metrics, KPIs, and compliance data

During my first year, I had the opportunity to participate in an FDA sponsor pre-approval submission inspection. During a pre-approval inspection, the health authority verifies the documentation from the clinical trials included in the submission and makes a recommendation internally to the Health Authority on whether or not to approve the product. I worked with the sponsor team to gather the necessary documentation before, during, after the inspection and interacted with the inspectors during the inspection. This experience has been very valuable to my fellowship especially in my work on inspection readiness.  Another opportunity that I had during my first year was working on a quality improvement project to map the informed consent process, which included drafting the global template, recording of consent in the eCRF and the use of the samples and data.  Through this project, I continued to develop effective communication and presentation skills by writing the meeting minutes for the team and creating presentations and process flows.

My preceptor and I have started to plan for the second year of the fellowship where I will get direct experience to various parts of the drug development process from research to commercialization of a product. I am excited to continue my training with the clinical quality team at NIBR next year!

 Kaitlin Bova, PharmD, is a Quality Assurance Post-Doctoral Fellow with MCPHS University and Novartis