Introduction
At EVERSANA, we’re at the forefront of regulatory work in Canada, and recently, our team has been delving into the realm of PRCI (Public Release of Clinical Information) in Canada and submission Policy 0070 (Regulation EMA (EU) 536/2014) in Europe). In a recent conversation, Deborah Brown, Lead, Strategic Partnerships, sheds light on the intricacies of this process, the technology behind it, and how it positions EVERSANA as a valuable partner for pharmaceutical companies. Let’s dive into the key takeaways from this insightful discussion.
Understanding PCRI
Question: What is PRCI, and Why Does it Matter?
Deborah Brown: PRCI stands for Public Release of Clinical Information, a mandate in Canada. In Europe this requirement falls under the broader Clinical Trial Regulations (CTR). These requirements compel pharmaceutical companies to publicly release all clinical information used in the drug submission process after regulatory approval. This information, often comprising hundreds of thousands of pages, is made available to foster innovation, allowing researchers and developers to build upon existing knowledge.
EVERSANA’s Role in PRCI
Question: What role does EVERSANA play in PRCI?
Deborah Brown: EVERSANA plays a crucial role in PRCI by offering a service that goes beyond traditional regulatory processes. Our team utilizes a combination of technology and manual processes to ensure the accurate redaction and anonymization of sensitive patient information from extensive clinical documents. This approach enhances efficiency, consistency, ensuring compliance with PRCI requirements while protecting patient confidentiality.
Global Reach and Market Applicability
Question: How does EVERSANA cater to small to mid-sized pharmaceutical companies launching assets in Canada, and how does the company’s local expertise add value to clients navigating regulatory landscapes?
Deborah Brown: While the release of clinical information is a mandate in Canada, EVERSANA’s services extend well beyond this in Canada as well as globally. We particularly cater to the needs of small to mid-sized pharmaceutical companies who wish to enter the Canadian market, creating a blueprint for them that includes a comprehensive evaluation of their brand(s) potential in Canada. This evaluation includes market access and pricing findings, a commercial assessment that provides insights into the competitive market, market share expectations, key stakeholders and their insights, regulatory gap assessment and strategy. With this integrated view of the market, our clients can make the right decision about if, how and when to enter the Canadian market. As one of the world’s top 10 pharmaceutical markets and home to some of the highest per capita healthcare spending on the globe, Canada should be a strategic priority for pharmaceutical manufacturers, and this local evaluation is a key investment before entering this lucrative but challenging market.
Technology vs. Service
Question: How does EVERSANA differentiate itself in its approach to PRCI compared to other offerings, and how does the combination of technology (machine) and the expertise of EVERSANA’s Subject Matter Experts (SMEs) contribute to navigating the complexities of PRCI efficiently while ensuring precision and compliance with regulatory standards?
Deborah Brown: EVERSANA’s approach involves dual systems that offer additional checks and balances rather than providing either a fully manual or fully automated process. Clients come to us for our expertise and capabilities in navigating the risk of PRCI effectively and efficiently. While technology plays a significant role in automating parts of the process to ensure consistency in our redactions, the human touch of our SMEs ensures that we truly mitigate client risk by ensuring that all personal health information is reviewed contextually to de-risk the possibility of re-identification.
Differentiation in the Market
Question: How does EVERSANA’s combination of AI algorithms and manual review contribute to its unique PRCI offering, ensuring efficiency, contextual understanding, expertise, precision, consistency, and safeguarding patient privacy?
Haritha Sama, Director, Automation CoE: EVERSANA distinguishes itself by combining Machine Learning (ML) with a human review process. This dual approach ensures not only the efficiency through technology but also the contextual understanding and expertise of our regulatory team.
The dual-phase approach in the anonymization process involves the utilization of Generative AI and human SMEs. In the first phase, Machine is tasked with initial document annotation and redaction. The underlying algorithms are trained to recognize specific patterns, such as patient identifiers and unexpected and rare adverse events or medical history, automating the initial stages of redaction. The efficiency gained through ML allows for a more streamlined and timely anonymization process.
The second phase involves a thorough Quality Assurance (QA) review conducted by a team of human regulatory/QA experts with input from safety and medical experts. This review ensures precision and consistency, addressing potential errors or discrepancies that may have been overlooked during the automated phase. The combination of AI efficiency and the meticulous scrutiny of human reviewers results in a comprehensive and precise anonymization methodology.
The initial phase with Machine Learning and Generative AI provides speed and efficiency in recognizing patterns and automating redaction. The subsequent human QA review adds a layer of scrutiny, precision, and contextual understanding that is crucial in the complex field of clinical information.
This collaborative approach addresses the strengths and limitations of both AI and human review, resulting in a comprehensive anonymization methodology that not only meets regulatory standards but also safeguards patient confidentiality effectively.
Conclusion
As the pharmaceutical landscape evolves, EVERSANA continues to pioneer innovative solutions. Our expertise in PRCI not only ensures compliance with regulatory requirements but minimizes client and patient risk.
Ready to learn more? Schedule time to talk with our experts and explore how EVERSANA can support your regulatory needs.
Author
Deborah leads EVERSANA’s partnership expansion plans for the commercial business in Canada. Her career spans more than 30 years in marketing, regulatory, product planning and commercial leadership in Canada and the U.S. Prior to…
Haritha is a highly accomplished and forward-thinking professional with a proven track record in healthcare IT consulting and project delivery management within the healthcare and pharmaceutical industries. With a strong belief in technology’s potential…