A recent Springer June 2025 publication highlights RWE’s growing role in supporting safety and efficacy evaluations in supplemental FDA approvals—especially in oncology, which represented 43.6% of submissions with RWE. 📊🧬
RWE provides complementary insights beyond traditional clinical trials—now informing every stage of the product lifecycle, with regulatory bodies increasingly using it to guide drug development, clinical trial design, and post-market evaluation.
While traditional methods of RWE generation involve syndicated, tokenized approaches—leading to mismatches, missing & incomplete data—Clinakos Inc.’s novel patient-centric AI-powered RWE generation approach integrates patient-level data from multiple primary sources—EHRs, claims, labs, pharmacies, and unstructured clinical notes—curating them into validated longitudinal records. By starting with the patient and connecting all relevant data, rather than blindly matching siloed datasets, completeness, accuracy, and clinical context are greatly improved. ✔️📈
As regulatory landscapes evolve, leveraging real-world data with precision and rigor has never been more critical—and @Clinakos is ready to support this new era of drug development. 💪
Interested in knowing about our rare disease-specific capabilities?
Reach out to us at [https://lnkd.in/gp3gUmXc]
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