Canada plays an important role in the global clinical research landscape. With over 3,500 ongoing and planned studies and approximately 900 new trials authorized each year by Health Canada, the country maintains a steady level of research activity. This volume reflects a well-established research infrastructure supported by a comprehensive regulatory framework and a focus on continuous improvement in clinical trial processes.

At Florence, we’re proud to support research teams across Canada with compliant, efficient, and patient-centric technology solutions. But what should sponsors, CROs, and sites know to confidently conduct trials using electronic systems and stay ahead of regulatory shifts in 2025?

Canada’s clinical research environment is guided by a comprehensive and evolving regulatory framework supported by Health Canada through:

• The Regulatory Stock Review Plan – ensures current regulations remain effective, eliminating outdated or redundant policies.
• The Forward Regulatory Plan – introduces future-ready guidance to keep pace with scientific and technological innovation.
• The Clinical Trials Modernization Initiative – proposes revisions to support Decentralized Clinical Trials (DCTs) and Risk-Based Monitoring (RBM), aimed at improving trial efficiency while safeguarding participant safety.

These strategies underscore Health Canada’s dedication to global harmonization and regulatory agility, helping sponsors and research teams prepare for what’s next.

Preparing for ICH E6(R3): Embracing Digital, Decentralized Trials

With the ICH E6(R3) guideline reaching Step 4 in January 2025, significant changes are on the horizon. While no countries have adopted it formally yet, Canada—having participated in the Expert Working Group—is expected to align its regulations soon. This will accelerate: 

• Increased adoption of DCT models
• Greater use of digital technologies like eConsent and remote monitoring
• Emphasis on risk-based and quality-by-design approaches

Florence’s platform is already designed to support these principles—empowering hybrid workflows, enabling remote collaboration, and streamlining regulatory compliance. Find out how Sites Can ensure they are aligned with ICH E6 R3 and how Sponsors Can Ensure Site Alignment.

The Privacy Landscape: Fragmented, But Evolving Toward Harmonization

Privacy compliance in Canada is multifaceted. While the Personal Information Protection and Electronic Documents Act (PIPEDA) provides federal guidelines, many provinces enforce their own frameworks—often stricter and more closely aligned with the General Data Protection Regulation (GDPR) standards.

Notable provincial developments:

• Quebec’s Law 25, officially titled An Act to modernize legislative provisions as regards the protection of personal information (formerly Bill 64), came into effect last year. This law introduces a range of updated privacy requirements designed to strengthen individual data rights and bring Quebec’s framework closer to GDPR. 
• Alberta’s Personal Information Protection Act (PIPA) is currently under review, with 12 recommendations released earlier this year aimed at broadening the legislation’s scope to more closely align with international privacy standards.
• Other provinces, such as Ontario and British Columbia, are also preparing to update their privacy laws to better align with federal legislation and respond to evolving data protection and technology-related challenges.

At Florence, privacy-by-design is core to our technology. We help clinical research organizations navigate federal and provincial laws, enabling compliant operations across jurisdictions.

Bill C-27 and the Future of AI Regulation in Research

Bill C-27—Canada’s proposal for updating privacy laws and regulating artificial intelligence (AI)—was delayed due to a parliamentary shutdown. If reintroduced, it is expected to introduce three key components:

• Consumer Privacy Protection Act (CPPA), which would replace Part 1 of PIPEDA
• Data Protection Tribunal Act – Would establish an administrative tribunal to review Privacy Commissioner decisions and impose penalties.
• Artificial Intelligence and Data Act (AIDA) – Would regulate high-impact AI systems with a focus on transparency and risk management, similar to the EU’s AI Act. 

Let’s Transform Research Together

As Canada enters a new era of clinical trial modernization, Florence is your trusted partner for compliant, future-ready research operations.

Contact us to learn more about digitizing your trials while staying aligned with evolving regulations and privacy frameworks.