Reflections from the SOCRA Canadian Regulatory Conference 2025: Closer to patients, stronger as an industry

Participating in the SOCRA Canadian Regulatory Conference 2025 held in Toronto was a deeply enriching experience both professionally and personally. It allowed me to reconnect with the foundations of our work in clinical research and explore how shared policies, tools, and experiences are transforming our industry. As part of Stiris, it was inspiring to see how these ideas translate into concrete actions to improve access, quality, and efficiency in clinical trials. It also reminded me that despite complex challenges, we have a strong, innovative, and human Canadian ecosystem.

At Stiris, we remain steadfast in our commitment to support patients, sponsors, and sites at every step of the clinical research journey.

An evolving regulatory environment

The clinical trials industry is constantly changing. Staying up to date with Canadian regulations, Good Clinical Practices (GCP), and emerging innovations not only ensures regulatory compliance but also allows us to identify new opportunities that benefit patients and optimize treatment development. This ongoing updating is key to providing agile, informed solutions aligned with the best regulatory practices nationally and internationally.

Basics remain key

Although no regulatory changes were announced, a key lesson emerged: the most common findings in Health Canada inspections continue to be related to basic documentation, especially training records.

We firmly believe that maintaining high standards in every aspect of documentation is essential to ensure regulatory compliance. Therefore, we proactively work with our teams and partner sites to identify improvement opportunities, ensure best practices, and make sure everything is in order before any official review. This attention to detail reflects our commitment to operational excellence and integrity in every study.

Driving collective knowledge

One of the great benefits of attending this conference was discovering tools and resources already available in Canada to strengthen our operations. From UHN’s new tumor measurement software to OHRI’s monitoring training program and the CANReview ethics review system, these solutions enable us to offer our sponsors and partners a more agile, informed, and strategic service.

Additionally, these events foster connections with passionate and committed colleagues, enriching our professional networks and helping us grow as an organization.

Bringing trials closer to those who need them most

A concrete example of innovation presented at the event was the Canadian Remote Access Framework (CRAFT), driven by the Canadian Clinical Trials Network and Health Sciences North. This initiative aims to expand trial access for patients in rural and remote communities through regional hospitals acting as satellite sites. Avoiding the activation of full sites saves time and resources without sacrificing patient access. At Stiris, we are excited by this approach that combines operational agility with true patient-centeredness.

Reconnecting with what matters

Beyond the technical and regulatory aspects, the conference was an opportunity to reconnect with the purpose of our work. Listening to Kayliegh Iacovitti from the Retina Centre of Ottawa speak about using emotional intelligence to support patients during a clinical trial was deeply inspiring. It reminded me that at the end of the day, everything we do revolves around them: patients who need options, hope, and support.

What lies ahead?

I was pleased to see that Health Canada continues advancing regulatory modernization through the Forward Regulatory Plan 2024–2026. Its upcoming publication in the Canada Gazette, Part II, shows a clear commitment to facilitating more accessible and efficient trials. Although Canada represents only 0.5% of the world’s population, we lead the G7 in clinical trial productivity with a 4% global participation. This is an achievement to be proud of.

Among all the resources discussed, CANReview particularly caught my attention. Exploring how we can integrate it into future Stiris projects seems like a strategic step to simplify processes and accelerate study start-up in Canadian institutions.

Without a doubt, participating in events like the SOCRA Canadian Regulatory Conference reaffirms the value of continuous learning and collaboration to drive innovation in clinical research. These spaces inspire us to raise our standards and always strive for excellence so that trials become more accessible, efficient, and inclusive.

At Stiris, we are convinced that by working together with commitment, we can build a future where patients have better access to innovative treatments and where every study has a real, positive impact on their lives.