Expediting Development of Rare Disease Therapies for the Public Good
Contact Us: service@regalintel.com
Expediting Development of Rare Disease Therapies for the Public Good
Contact Us: service@regalintel.com
Accelerate Therapeutic Development with Real-World Evidence
Regal Intel: Your Non-Profit Partner in Rare Disease RWE
Unlock the future of rare disease research by leveraging Real-World Evidence (RWE) to bridge the data gap across discovery, clinical trials, and regulatory approval.
Our Mission, Focused
To accelerate the entire development pipeline for life-saving therapies for rare diseases. We provide expert, AI-driven intelligence to pharmaceutical and biotech partners, generating the Real-World Evidence (RWE) required to validate targets and support submissions.
The RWE Challenge We Solve
We specialize in navigating the intricate regulatory pathway for ultra-rare conditions where traditional Randomized Controlled Trials (RCTs) are often infeasible. Our expertise lies in transforming fragmented clinical and genetic data into regulatory-grade RWE that supports expedited development processes across all phases.
The Bottleneck: The Unique Data Hurdles of Rare Disease Appr
Trial Impossibility
Genotype-Phenotype Gap
Trial Impossibility
Difficulty in recruiting enough subjects (N < 100) from diverse patient pools makes randomized trials for ultra-rare conditions statistically and logistically impossible, stalling critical development.
RWE Quality & Trust
Genotype-Phenotype Gap
Trial Impossibility
Regulatory bodies (FDA/EMA) increasingly require RWE, but data from rare conditions are often low-quality, fragmented, and lack the structure needed to be regulatory-grade.
Genotype-Phenotype Gap
Genotype-Phenotype Gap
Genotype-Phenotype Gap
Crucial genetic and cytogenetic information is trapped in unstructured clinical notes, preventing effective target identification, genotype-phenotype correlation, and patient stratification.