Delineate

Delineate is an evidence assembly and modeling platform for pharmaceutical development, regulatory, and commercial teams. It extracts and structures clinical pharmacology reviews, EMA EPARs, published literature, AdCom briefing documents, and postmarket commitments into a queryable database across drug classes, so cross-asset evidence is ready before modeling begins. The platform supports go/no-go decisions, dose selection, trial design, indication prioritization, submission strategy, and plot digitization.

Core capabilities include evidence assembly, modeling and simulation, dose optimization, asset benchmarking, submission outputs, and plot digitization. Quality controls include dual independent extraction with formal arbitration, source-level verification, cross-study consistency checks, outlier flagging, and a full audit trail on every value. Databases are delivered in formats such as NONMEM-ready structures, with data dictionaries and QC reports.

Delineate serves clinical pharmacology and pharmacometrics, clinical development and trial design, commercial and lifecycle management, and regulatory affairs and market access teams. Case studies cover obesity drug, ADC, hybrid AI PK, pipeline intelligence, and surrogate endpoint databases. The platform is available by demonstration request, with a response within 24 hours.