A Quality-First Approach for AI-Driven Regulatory Writing

In the fast-evolving world of biopharma, regulatory writing is more than just documentation—it’s the bridge between groundbreaking clinical research and patient impact. But as clinical trials grow in complexity and data volume, the pressure on medical writers to deliver high-quality, compliant documents has never been greater.

Successful AI implementation in regulatory writing requires a deep understanding of what quality truly means. That’s why Peer AI has developed a comprehensive evaluation framework to quantify the quality of authored documents. Through extensive collaboration with in-house medical writers, subject matter experts, and biopharma regulatory teams, we have established key quality measures that are directly integrated into our AI-driven automated authoring workflows.

Quality begins with accurate clinical data processing and ingestion. Working closely with regulatory teams across multiple biopharma companies, we discovered that medical writers spend up to 60% of their time gathering and validating information from various clinical trial sources—time that could be better spent on writing. By incorporating this feedback, we’ve developed intelligent systems that accurately process trial-related files (e.g., SAPs, CSVs, clinical datasets, TFLs), creating a foundation for high-quality, compliant regulatory document creation.

Transparency in regulatory documentation builds trust and ensures quality. Through iterative development with our medical writing partners, we validated that traditional "black box" AI solutions fall short in clinical trial environments, where every conclusion must be verified against source data. Our platform, built with continuous customer feedback, provides complete traceability, mapping each AI-generated element in regulatory documents back to its source data files.

A quality-first mindset means we need to “show, not tell” when it comes to quality. We prioritize measurable quality, using data-driven metrics to track every project for both efficiency and quality. Key Performance Indicators (KPIs) are our benchmark, and our customers appreciate this level of rigor and transparency. For example, we have demonstrated a 94% efficiency gain while maintaining or exceeding customer quality metrics when authoring safety narratives (webinar on Oct 29, 2024). Similarly, we’ve achieved a 60% improvement in efficiency when authoring complex Phase 3 CSRs. These metrics, developed and refined through customer collaboration, provide tangible evidence of our commitment to maintaining the highest standards in regulatory documentation.

As we look to the future, AI will undoubtedly play an increasingly important role in shaping the regulatory writing landscape—and quality must remain at the forefront of every solution.