--- title: Hepatology description: >- A decade of hepatology cohorts in MASH, PBC, HCC, and HBV — longitudinal, regulatory-grade real-world evidence for your clinical and regulatory decisions. category: Page canonical_url: https://www.pedestalhealth.com/disease-areas/hepatology/ source: Pedestal Health license: © 2026 Pedestal Health. All rights reserved. slug: disease-areas/hepatology id: 3MVWnyBmNo0U1jQTFqvCHP contentType: page --- # Evidence that shapes decisions, not just supports them. **Hepatology** We partner with life sciences and health systems to deliver integrated hepatology evidence from clinical development to care delivery, supporting decisions at every stage. - [Talk to Our Team](#form) - [Hepatology Publications](/resources/publications/hepatology/) ## World-class hepatology expertise - [MASH / MASLD](#) - [Primary Biliary Cholangitis (PBC)](#) - [Primary Sclerosing Cholangitis (PSC)](#) - [Hepatocellular Carcinoma (HCC)](#) - [Hepatitis B (HBV)](#) ## One system, built for every decision a program faces Our work has shown us what the field actually needs: not just another retrospective data source or another standalone clinical trial, but a hybrid system that keeps generating evidence on the same patients as the questions evolve. Our approach guides the decisions that matter most to clinical programs in active development as they arise: ### Deep baseline characterization At enrollment, we capture structured and unstructured EHR data and patients consent to prospective data collection. The starting point is richer than claims or registry data alone, and the same patient stays in the system from there. ### Longitudinal follow-up The same patients, followed over years. Continuously updated structured and unstructured EHR data alongside the prospectively collected measures from enrollment. The substrate for natural history, disease characterization, treatment patterns, and comparative effectiveness. ### Partner-specific extensions Programs that need additional PROs, biomarkers, imaging, or other measures can activate them through dedicated protocols layered on the same patient population. ### Clinical trial infrastructure A network of activated sites and a continuously enrolled patient population already in the system, ready to support embedded prospective studies, external control arms, and trial work that draws on what's already running. ### Post-approval evidence Patients enrolled before approval and followed past launch on the same continuous infrastructure, with partner-specific protocols providing the rigorous structure required for post-authorization safety, real-world effectiveness, and long-term outcomes work. ## A decade of hepatology cohorts, built for the decisions ahead Pedestal Health has been building cohorts and contributing evidence in this space for over a decade, concentrating on answering the questions and guiding the decisions that matter most to clinical programs in active development. ### R&D Decisions - Disease characterization, natural history, and feasibility informed by longitudinal cohort data across diverse populations. - Protocol design and population selection grounded in real clinical contexts, including the patient subgroups underrepresented or systematically excluded from trials. - Prospective studies and clinical trials run within Pedestal's cohort and site infrastructure. - External control arms. - Sub-phenotyping and risk stratification. - Clinical development - Translational and Study teams - Program teams ### Approval & Commercialization Decisions - Post-authorization safety studies. - Supplementation of regulatory submissions with longitudinal evidence. - External control arm contributions to FDA and EMA filings. - Comparative effectiveness. - Market access evidence on how patients receiving advanced therapy in routine practice compare to trial populations. - Publication strategy and support. - Regulatory - HEOR / Market Access - Payers - Medical Affairs ### Care Decisions - Treatment pattern characterization in routine practice. - Long-term effectiveness and safety. - Clinical decision support evidence. - Therapeutic inertia and treat-to-target gap analyses. - Clinicians - Health systems - Care delivery teams - PI-led research - [Talk to our team](#form) ![Scientists Conducting Laboratory Research and Analysis](https://images.ctfassets.net/h4s3ip99qawo/mBhBB0nzH4CMd3Dwt3b7k/1b5f09dd6f6342c3c8ee16a400e2aa15/iStock-1392312953.jpg) ## The same cohort. The same patients. Answering new questions about how to treat them better **Nomenclature, biomarkers, and approved therapies all changed. The cohort kept informing and answering.** The cohorts referenced here are managed under longstanding research protocols established by Pedestal Health (formerly Target RWE) and our academic partners. Protocol names including TARGET-NASH and TARGET-DERM appear in published literature and are referenced where relevant for scientific accuracy. ### Building the cohort that would support a decade of MASH program decisions **2017** *R&D Decision* Multi-site longitudinal observational cohort designed across the full NAFLD/NASH spectrum, with adult and pediatric arms, EHR abstraction, biospecimen collection, and PRO infrastructure. The substrate every later decision would draw on. - [Explore the research.](/resources/publications/abstract-manuscript/design-and-rationale-for-a-real-world-observational-cohort/) ### Validating non-invasive tests and risk classification **2019–2021** *R&D Decision* FIB-4, NFS, and VCTE evaluated against locally interpreted liver biopsies across academic and community sites. A pragmatic biopsy-free risk classification system validated against mortality, liver events, and MACE — the kind of work that can shape how MASH trial enrollment criteria move beyond biopsy. - [Explore the research.](/resources/publications/poster-presentation/fibrosis-assessed-by-non-invasive-tests-is-similar-to-liver/) ### Disease progression evidence **2023** *Approval & Commercialization Decision* Time-to-event analyses of MASH progression to compensated cirrhosis, decompensation, and all-cause mortality across severity strata. Paired-biopsy progression rates published the same year — the kind of data that supports state-transition modeling and trial powering for sponsors approaching submission. - [Explore the research.](/resources/publications/poster-presentation/time-to-disease-progression-and-all-cause-mortality-in/) ### PRO instrument validation and effectiveness evidence in the new MASH treatment era **2024** *Approval & Commercialization Decision* NASH-CHECK PRO stability validated across clinically stable patients, supporting regulatory PRO requirements. FIB-4 trajectory analysis linking biomarker change to clinical outcomes, in partnership with Madrigal. Concordance of MASLD and NAFLD nomenclature confirmed in the cohort to preserve continuity of years of longitudinal data through the 2023 nomenclature shift. - [Explore the research.](/resources/publications/poster-presentation/stability-of-the-nash-check-patient-reported-outcome/) ### Real-world treatment patterns across the new therapeutic landscape **2024–2025** *Care Decision* Real-world utilization characterization of GLP-1 RAs, SGLT2 inhibitors, and DPP4 inhibitors across MASLD disease phenotypes — the kind of evidence that informs how clinicians and health systems understand emerging treatment use in routine practice. - [Explore the research.](/resources/publications/oral-presentation/use-of-glucagon-like-peptide-1-receptor-agonists-in/) ### Cardiovascular risk and underrepresented populations in routine MASLD care **2025** *Care Decision* Standard CV risk tools (Framingham, Pooled Cohort Equations, AHA PREVENT) shown to systematically miscalibrate in MASLD. MetALD subgroup characterized — a population systematically excluded from MASLD trials but present in real practice. - [Explore the research.](/resources/publications/abstract-manuscript/cardiovascular-risk-assessment-tools-are-insufficient-for/) ## Recent Hepatology publications - [See all hepatology publications](/resources/publications/hepatology/)