Solaris Innovations Canada

ClearAE is a Canadian digital health startup developing a real-time intelligence and data-quality improvement layer for clinical research and safety operations. The platform runs in parallel with existing electronic data capture (EDC) and safety reporting systems, helping research teams identify data quality gaps, timeline risks, and reporting inconsistencies without changing official workflows.

ClearAE is designed to operate in “shadow mode” as a read-only solution. It does not replace validated systems or generate regulatory submissions. Instead, it provides an additional layer of oversight by passively monitoring data streams, documents, and reports to surface potential issues for human review. This approach reduces administrative burden, improves audit readiness, and supports more reliable safety oversight.

By combining advanced analytics and AI-driven pattern recognition, ClearAE helps study teams detect potential misclassification of adverse events, missing information, and deadline risks earlier in the process. This enables proactive intervention while maintaining full human decision authority.

ClearAE is currently at the prototype stage, with early validation discussions underway with academic and hospital partners in Canada. The company’s long-term vision is to improve the safety, efficiency, and trustworthiness of clinical research infrastructure, supporting better outcomes for patients, sponsors, and regulators worldwide.