In this edition of our Career Perspectives series, we are delighted to feature Patti Arsenault, Vice President, Quality Assurance, at Cytel. Patti discusses her career in quality assurance, how clinical trials have evolved over the years, balancing regulatory compliance with innovation, and more. After 11 impactful years at Cytel, Patti is retiring, having shaped standards that will guide the organization for years to come.

Can you give us a little background on your career?

I began my career in programming, using Assembler, Fortran, and Cobol, then moved into database and web programming using SQL and Java Script. While working at an epidemiological company, I moved into data management, which felt like a natural next step. I joined Cytel to build the data management team, and later, was asked to step into a quality role. I started at Cytel 11 years ago and have been the Vice President of Quality Assurance (QA) at Cytel for almost 8 years now.

You’ve had a fascinating journey from programming to data management and now leading QA. What motivated each of those transitions?

Each transition felt like a natural progression. When I began my career in programming ― using punch cards! — it was all machine-based communications. But I’ve always been more of a people person, so when given the opportunity to move into data management, the transition was easy.

At my previous company, data managers were also programming SQL within Oracle, and I was part of a team that developed a web-based Electronic Data Capture (EDC) system. During this transition and time, I organized and brought together a disparate group of data managers who had been working independently under different principal investigators, each using their own processes. Bringing this team together and centralizing and standardizing the processes was so much more efficient.

The skills I gathered there ― technology, good communication and organization, team building, and an understanding of client and regulatory needs — were the same skills needed to help Cytel’s quality groups switch from a dispersed setup into a global, unified model.

In your experience improving processes, are there particular questions or mindsets that help you identify what needs to change?

Clinical trial process originally started on paper, and much of what exists today mimics that still. Given that, the key mindset that is needed is being willing to challenge the norm. But that mindset has to be coupled with having the right gatekeepers, people who can ensure that the proposal will be in line with regulatory and client expectations.

This is what is so great about the Cytel QA team. We have a depth of experience that allows us to challenge an existing process and inspect the proposal. We have some great debates about why we do the things we do, and the shared goal of those conversations is always continuous improvement.

When you joined Cytel in 2014, what was your vision for the data management team you were building?

My vision was for the data management team to become well known and trusted in the industry as the best. I was quite excited about building a global team and creating opportunities for team members to learn from each other’s experiences. One of the advantages of hiring data managers at Cytel was the blend of experience we could bring together, both from the sponsor side as well as the CRO side. I wanted to develop the team to have a diverse skillset, making us an adaptable group that brings even more value to our clients.

QA at Cytel touches on so many areas — from GCP to data privacy to customer satisfaction. How do you prioritize and manage such a broad scope?

Yes, our responsibilities span across many domains! This is due to the rapid growth Cytel has experienced. Everyone at Cytel rolled up their sleeves and truly dug in. Through training within the team and assigning a task owner and one to many back-ups, we can manage the broad scope and maneuver tasks amongst the team as needed.

Clinical trials have evolved significantly over the years. What are some of the biggest changes you’ve seen in how quality is managed?

Probably the biggest change I’ve seen is adding risk assessment and an acceptable level of tolerance. It’s a shift that acknowledges that perfection, while always desired, is not always achievable.

Additionally, the speed of acquisition and the types and amount of data have increased substantially. With that comes pressure to complete tasks more quickly, so it is important to strike a balance between efficiency and the quality desired.

How do you balance regulatory compliance with innovation, especially in a fast-evolving field like clinical research?

Regulations rarely tell you exactly how to do something. This allows us to be creative and discuss whether a solution truly achieves the goal of the regulation. We also actively monitor a number of regulatory websites to stay abreast of emerging regulations.

Finally, we welcome our client audits. On average, we conduct about 30 per year. If a client questions an approach they haven’t seen before, it opens a discussion between them and our internal team. These conversations often turn into learning experiences for all involved.

What do you think is the most misunderstood aspect of QA in clinical trials?

Quality assurance is often mistaken for quality control (QC). QA is intended as a proactive approach; we help prevent mistakes or defects. QC, on the other hand, should detect errors after they occur. Of course, using QC data will help us identify processes that are not working as intended!

You’ve built and led your team for over a decade now. What qualities and skills do you look for when building a strong, stable team? And how do you approach supporting junior team members as they grow into their roles?

QA folks need to know how to interpret a regulation, understand a procedural document, communicate clearly, and have a keen sense of organization.

We’ve built some pretty clear growth paths for the QA team. It’s part of my responsibility to work with every team member to find out where they want their career to go, and to help them in realizing that. For those who have the desire to go into auditing, there are multiple steps that you need to be trained in and master as you grow into an auditor role. Some junior team members have, with support, trained in data privacy. For team members who want to be more technical, we have the opportunity to work on the Trackwise application.

How do you foster shared learning across such a diverse QA team?

We maintain a skill matrix where each skill has an owner responsible for training others. We also meet as an entire group on a monthly basis and have people present on a wide range of topics — from regulations to a process or a new, clever way to use Excel. In addition to the monthly full-team meetings, we have several sub-groups such as auditors, change control, computer systems validations, and more, who meet regularly and share ideas, problems, and solutions.

You’ve led some incredible community initiatives like the yearly backpack drive providing school supplies for a local school and providing families with Thanksgiving meals. What drives your passion for giving back, and how do you see these initiatives influencing company culture?

I’ve been fortunate in my life, and I love finding opportunities to help others. A backpack is a small monetary hit for most of us at Cytel, but the impact on a middle schooler who may start school without one is huge!

I believe that people naturally enjoy doing things as a group, to feel part of a group or community. And the feel-good effect of doing good, even if it’s a little thing, builds comradery, which in turn enhances company culture.

Looking back on your 11 years at Cytel, what are you most proud of?

I am proud of our first-rate quality team! We are a dedicated and knowledgeable bunch and try to set the tone of working with the functions and business units rather than policing them. Quality is not an easy role to be in, yet my team comes to work smiling every day.

Finally, when you’re not diving into work, what hobbies or passions keep you busy?

My passion is my family — 3 sons and daughters-in-law and 6 grandchildren keep me busy. I golf and bike and try to be at the beach whenever I can.

Thank you, Patti, for sharing your experience!

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