AI-Powered RWE/RWD for Rare and Orphan Diseases

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Executive Summary: At Regal Intel, we specialize in leveraging the power of Real-World Evidence (RWE) and Real-World Data (RWD) to support the development and regulatory submissions of therapies for orphan and rare diseases. We understand that in this unique ecosystem, every data point is crucial. Our AI-powered platform helps you transform real-world information into actionable evidence that accelerates your path to market and brings treatments to patients in need.

Real-World Data (RWD) encompasses information from sources such as electronic health records (EHRs), patient registries, and patient-reported outcomes. When analyzed to inform clinical decisions, RWD becomes Real-World Evidence (RWE). This is especially critical for rare and orphan diseases where small, geographically dispersed patient populations make traditional clinical trials challenging.

Our work focuses on guiding innovators to strategically use RWE/RWD to:

• Provide insights into the natural history of a disease, informing clinical trial design and identifying endpoints.
• Generate a more complete picture of a therapy's safety and efficacy in real-world settings.
• Support regulatory submissions by supplementing or, in some cases, replacing traditional clinical data.

Regal Intel’s team of experts assists clients in every step of the RWE/RWD journey, with a strategy built on trust and cutting-edge technology. Our work is not about simply collecting data—it's about building a robust, regulatory-compliant strategy from the outset.

• AI-Driven Data Strategy & Protocol Development: We use our AI platform to identify the most relevant data sources and develop study protocols that align with both regulatory expectations and your research questions.
• AI-Enabled Regulatory Intelligence & Submissions: We use AI to analyze complex, unstructured RWD and translate it into compelling evidence for regulatory submissions (e.g., IND, NDA, BLA).
• Data Quality & Compliance: We ensure the data you collect meets the highest standards for quality, integrity, and privacy, adhering to global regulations and data protection laws. Our non-profit model and AI-powered tools for ethical data governance give us unparalleled access to patient data, creating a unique advantage for our partners.

Our dedicated focus on rare and orphan diseases gives us unmatched expertise in this critical area of regulatory science. We understand the scientific, clinical, and compliance challenges that innovators face and stay at the forefront of evolving policies.

• Strategic Partnership: We are more than consultants; we are an extension of your team, dedicated to your success.
• Unmatched Expertise: Our decades of hands-on experience ensure that your RWE/RWD strategy is sound and your submissions are compelling.
• Patient-Centered Approach: We help you align your RWE/RWD initiatives with patient-centered goals, which resonates with both regulators and patient advocacy groups.