Life sciences
Departments do not fail for lack of tools. They fail for lack of a shared brain.
We redesign how clinical, safety, medical affairs, HEOR, and commercial actually share data and authority — so integrative AI is a company capability, not a pilot.
Concrete offers
Infrastructure, not a demo.
Medical-data architecture
One operating picture across clinical, safety, medical, and evidence. Objects, owners, and the cadence of decisions. The CLASS pattern: pharmacovigilance, HEOR, and competitive signal in the same brain.
Submissions operating system
NDA / eCTD process, safety synthesis, and Advisory Committee readiness. Built from Forest, Covance, and Celgene rooms — not from a vendor’s module list. The product is a way of working your teams can run on the next molecule.
Integrative AI for medical information
Natural-language systems over labels, literature, real‑world evidence, and pharmacogenomic coding — placed inside existing medical and safety workflows. Personalized-medicine infrastructure, not a chat window on the intranet.
Department redesign
People, process, and platforms so clinical development, safety, and commercial can build with the same AI. We name the authorities, kill the duplicate truths, and leave a model your VPs will use when we are gone.
The rooms this comes from
Memantine. Covance. Celgene. CLASS.
If your problem is a submission, a safety signal, a real‑world evidence gap, or an AI program that cannot leave the innovation group, write with the molecule and the stall. Grace S. Lee has helped 500+ drug and biotech companies save hundreds of millions of dollars over 30+ years and helped get 300+ drugs, biologics and medical devices approved by the FDA, EMA, MHRA and SFDA, from the Safety Intelligence System for Sanofi and Pfizer to real‑world data strategy for Pfizer and AbbVie. We will tell you whether the job is architecture, an operating system, or a named-system build.