Summary
In this episode of Driving the Business of Science, Keith Parent, CEO of Court Square Group, discusses pharmacovigilance compliance for small and mid-sized sponsors with Betty Cory, President of Regxia. Betty explains that pharmacovigilance monitors drug safety in real-world use, often revealing unforeseen adverse effects. Small companies struggle with managing vast amounts of data, necessitating electronic systems. Betty emphasizes the importance of finding partners who understand small businesses’ needs and can provide tailored solutions. Court Square Group’s platform, RegDocs365™, is highlighted as a fit-for-purpose solution. Betty also shares her background and the philosophy of Regxia, which focuses on becoming an integral part of clients’ operations.
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Key Takeaways
Introduction and Overview of Court Square Group
- Keith Parent introduces himself as the CEO of Court Square Group and mentions the podcast’s focus on driving the business of science.
- Keith explains that Court Square is a managed service firm that manages infrastructure for life science companies.
- He introduces Betty Cory, the president of Regxia, a consulting firm based in Canada, that specializes in pharmacovigilance compliance for small and mid-sized sponsors.
- Keith shares his excitement about learning more about pharmacovigilance from Betty.
Betty Cory’s Background and Regxia’s Services
- Betty Cory provides an overview of Regxia, a consulting firm that serves small to mid-sized businesses, focusing on regulatory, quality and pharmacovigilance consulting.
- Betty mentions that Regxia has been a partner with Court Square for many years.
- Keith humorously mentions the comfortable couches at Regxia’s booth at the DIA global show, which he enjoys visiting for breaks.
- Betty explains the importance of pharmacovigilance, which involves monitoring the safety of products in the real world, not just in clinical trials.
Challenges of Pharmacovigilance for Small Companies
- Keith and Betty discuss the challenges small companies face in managing pharmacovigilance data, including the volume and complexity of data.
- Betty emphasizes the need for electronic systems to handle the data, as manual methods are no longer sufficient.
- They discuss the importance of adjudicating adverse events and the role of medical personnel in this process.
- Keith shares his experience with patient registries and the need for adjudication in pharmacovigilance.
Importance of Electronic Systems and Compliance
- Betty explains the necessity of electronic systems for pharmacovigilance, as manual methods are insufficient for handling large amounts of data.
- She highlights the challenges small companies face in adopting expensive, complex systems designed for large companies.
- Keith and Betty discuss the concept of “fit for purpose” systems that are tailored to the needs of small companies.
- Betty emphasizes the importance of finding partners who understand the challenges of small companies and can provide tailored solutions.
Betty Cory’s Career Journey and Regxia’s Approach
- Betty shares her career journey, starting from research at the University of Toronto and moving to a contract research organization.
- She explains how she and her business partner, Lori de Munnik, founded Regxia to provide personalized, high-quality consulting services to small and mid-sized companies.
- Betty emphasizes the importance of working closely with clients and becoming an extension of their organizations.
- Keith and Betty discuss the benefits of their long-term partnership and the collaborative efforts between their teams.
Advice for Small Companies on Pharmacovigilance
- Betty advises small companies to focus on their core mission in pharmacovigilance and not get overwhelmed by data.
- She emphasizes the importance of finding partners who understand the unique challenges of small companies and can provide tailored solutions.
- Betty highlights the role of electronic systems in maintaining compliance and the need for proper documentation and validation.
- Keith and Betty discuss the importance of staying focused on the science and not getting distracted by unnecessary expenses.
Conclusion and Future Plans
- Keith thanks Betty for her insights and the valuable information she shared about pharmacovigilance and Regxia.
- They discuss their upcoming participation at the DIA global show and encourage listeners to visit their booths.
- Keith and Betty express their excitement about their ongoing collaboration and future projects.
- The podcast concludes with Keith thanking Betty again and wishing her the best for the upcoming event.