A late-stage biopharmaceutical company developing advanced therapies for chronic kidney disease partnered with Worldwide Clinical Trials to prepare a pivotal NDA submission for a novel calcimimetic. Following two large Phase III trials, they needed rapid, comprehensive regulatory documentation as both studies reached their data lock simultaneously, creating an aggressive 6-month timeline for a complete NDA package. Successfully meeting this deadline ensured uninterrupted drug development and timely regulatory review.
Read the full case study to learn about how we supported the company’s strategic goal of rapidly advancing this therapy to market, including:
- Clinical Study Reports (CSRs)
- Clinical summaries & nonclinical summary quality control (QC)
- Regulatory document formatting and Biometrics tables, listings, and figures (TLFs) for integrated summaries
