Sapien Labs

Product Introduction

1. Definition: Sapien Labs is a clinical trial technology platform that provides trial-grade external control arms (also known as synthetic control arms) specifically for Phase II and Phase III psychiatry programs. Technically, it is a data processing and cohort generation engine that transforms real-world clinical data (RWD) from electronic health records (EHRs) and therapy notes into validated, protocol-aligned control cohorts.
2. Core Value Proposition: It exists to reduce patient recruitment burden and accelerate psychiatric clinical trials by replacing or supplementing traditionally recruited control patients with a synthetic control arm built from real-world evidence (RWE). This allows clinical development teams to generate rigorous evidence with fewer patients, lower costs, and shorter timelines while aligning with emerging FDA guidance on external controls.

Main Features

1. Evidence Generation Co-Pilot: This feature allows clinical and biostatistics teams to interact with the synthetic cohort using natural language processing (NLP). Users can ask complex, protocol-specific questions about the external control arm data and automatically generate regulator-ready evidence packages. This transforms data exploration into direct analysis for regulatory submission.
2. Item-Level Traceability & Patient Journey Reconstruction: The platform does not provide black-box aggregates. It uses advanced record linkage algorithms to stitch together fragmented EHR data into coherent, longitudinal patient journeys. Crucially, it enables users to trace any derived psychiatric endpoint (e.g., a specific PHQ-9 score) back to the original clinical narratives, providing the audit trail required by regulators for external control arm validation.
3. Configurable Pipeline for Psychiatric Endpoint Derivation: At its core, Sapien Labs operates a multi-step, configurable data pipeline. It securely ingests and de-identifies raw clinical data under HIPAA protocols, reconstructs patient trajectories, and then applies validated NLP models to derive structured psychiatric assessment scales (like PHQ-9, HAM-D, PANSS) directly from unstructured therapy notes and clinical narratives. This pipeline outputs a synthetic control arm matched to a sponsor's specific inclusion/exclusion criteria.

Problems Solved

1. Pain Point: Extremely high patient recruitment costs and delays in psychiatric trials, especially for control arms, which compete for the same limited patient population as the treatment arm. This inflates clinical trial timelines and budgets and is a major bottleneck in CNS drug development.
2. Target Audience: Clinical development teams at pharmaceutical and biotechnology companies, specifically Clinical Operations leads, Biostatisticians, Medical Directors in psychiatry/neurology, and Regulatory Strategy professionals planning Phase II-III programs.
3. Use Cases: 1) Designing a hybrid control arm study where a portion of the control patients are replaced with an external cohort to reduce recruitment by 20-30%. 2) Generating historical control data for a single-arm trial in a rare psychiatric indication. 3) Conducting feasibility analysis and power calculations using real-world data before finalizing a trial protocol.

Unique Advantages

1. Differentiation: Unlike traditional real-world data vendors that sell raw datasets, Sapien Labs functions as a trial infrastructure partner, delivering a ready-to-analyze, protocol-aligned external control cohort with full regulatory documentation. It is also specialized exclusively in psychiatry and CNS trials, where endpoint derivation from notes is critical, unlike generalist RWD platforms.
2. Key Innovation: Its validated NLP models for psychiatric scale derivation from unstructured clinical notes. This solves the fundamental data problem in psychiatry—where key outcomes are documented in narrative form—by creating structured, traceable endpoints that match traditional clinical assessments, enabling the use of RWD where it was previously unreliable.

Frequently Asked Questions (FAQ)

1. How does Sapien Labs ensure its external control arms are acceptable to the FDA? Sapien Labs builds its synthetic control arms with a focus on regulatory-grade traceability and documentation, aligning with FDA guidance on Real-World Evidence and external control arms. Each derived endpoint can be traced to source data, and the platform generates evidence packages designed to meet regulatory submission standards for clinical trial data integrity.
2. What types of real-world data sources does the platform use? The platform ingests de-identified electronic health records (EHRs) and therapy notes from a network of US health systems and academic clinical partners. All data ingestion and processing comply with strict HIPAA de-identification protocols to ensure patient privacy and data security.
3. Can Sapien Labs' synthetic control arm integrate with our existing clinical trial systems? Yes, the platform is designed for seamless integration with existing clinical trial workflows. It allows for the export of cohort data in standard formats (e.g., CDISC SDTM) ready for import into your Clinical Trial Management System (CTMS) and standard biostatistical analysis software.
4. What psychiatric conditions and endpoints does the platform support? The platform specializes in deriving validated endpoints for major psychiatric conditions, including depression (PHQ-9, HAM-D, MADRS), anxiety (GAD-7, HAM-A), and psychosis (PANSS). These are derived from clinical narratives with strong agreement to traditional assessment methods.