We recently had a chance to catch-up with Jean Brislance, Senior Quality Compliance Engineer, to learn more about the work he is doing at Mednet and his thoughts on the challenges and opportunities for clinical trials. Jean’s role at Mednet is a critical one – he provides oversight to the overall quality system, including management of documentation and training, internal and external audits and corrective action requests.
Tell us a little about your background.
I have been at Mednet for about 13 years and in the industry for 22 years, working in clinical research and clinical outcomes for both sponsors and CROs, with specific experience in data management, quality assurance, and compliance.
How does your role impact or improve clinical trials for customers?
Quality compliance can be a challenging discipline fraught with disparate interpretations of guidances and simultaneous pressure to maintain ongoing compliance. Our team provides the independent quality oversight which ensures the proper validation documentation is in place and procedures are being followed in compliance with industry regulations and guidance.
I like to think my previous clinical trial experience, including as a user of an EDC, helps me better understand and appreciate the perspective of our customers and the challenges they face.
What is your most significant achievement since joining Mednet?
A few years ago, we implemented a new quality management system at Mednet. It ended up consolidating several different systems into a single, integrated platform, which resulted in numerous process improvements. Streamlining quality management helps to keep Mednet’s environment compliant, and it also enables us to address client needs more efficiently and effectively.
Are there any notable trends you are seeing among current clients?
Yes. Many of Mednet’s customers are wanting to do more remotely. Granted, some of this was driven by the impact of COVID-19, but even prior to that, we were receiving more requests for remote audits and assessments. We used this as an opportunity to rethink some of our traditional practices and make changes and enhancements to allow for easier facilitation of these types of events. We’ll continue to optimize these processes to ensure we are able to support our customers preferences and needs, both now and in the future.
What do you see for the future of clinical trials?
I think a key challenge for the industry will be the balancing act required to bring new technologies into clinical trials. Technologies evolve pretty quickly. In the early 2000’s, I worked for a sponsor that was a very early adopter of EDC, so I lived through the transition away from paper-based trials and the challenges it presented. In a regulated industry, it is our job to maintain the delicate balance between embracing new tools and ensuring integrity, validity, compliance, and security. It will be imperative for technology companies like Mednet to demonstrate the validity of their offerings, coupled with the industry becoming more adaptable to technological advances.
Speaking of data and security, how do you see data privacy and security impacting clinical trials in the future?
I believe data privacy and security will be at the forefront of new technology advances in clinical trials. The Health Insurance Portability and Accountability Act (HIPAA) and the implementation of the General Data Protection Regulation (GDPR) will continue to spark further discussions and raise compliance questions, particularly with the addition of new data sources. We are also now seeing individual states crafting their own data privacy laws, adding significant nuance and complexity to an already complicated landscape.
How do you believe Mednet can make a difference in clinical trials?
I believe our experience and service is a differentiator. Mednet has been providing customers with EDC and eClinical solutions for nearly 20 years, and our experienced team is well-equipped to help our customers implement their systems in the best and most efficient ways possible.
Jean is motivated by the human element of clinical trials and the impact the industry is making on people’s lives. “Years ago, while I was working for a sponsor, a surgeon was speaking at our company meeting,” said Jean. “He told of harrowing tale of a woman in a life flight helicopter who was defibrillated multiple times on the way to the hospital – then he brought her out on stage. A device we manufactured help save her life and she wanted to thank everyone. During our daily routines of conducting studies and supporting the systems involved, we are sometimes far removed from the success stories, and we need these reminders. This is why we do what we do.”
Experiences like this help to drive our industry to improve all aspects of clinical trials. This poignant story connected Jean to a bigger purpose. It also served as a reminder of how important the work supporting clinical research is to people around the world.