We partner with life sciences and health systems to deliver integrated hepatology evidence from clinical development to care delivery, supporting decisions at every stage.
We partner with life sciences and health systems to deliver integrated hepatology evidence from clinical development to care delivery, supporting decisions at every stage.
World-class hepatology expertise
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:
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.
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.
Programs that need additional PROs, biomarkers, imaging, or other measures can activate them through dedicated protocols layered on the same patient population.
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.
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.
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.
Clinical development
Translational and Study teams
Program teams
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.
Regulatory
HEOR / Market Access
Payers
Medical Affairs
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.
Clinicians
Health systems
Care delivery teams
PI-led research
Treatment pattern characterization in routine practice.
Long-term effectiveness and safety.
Clinical decision support evidence.
Therapeutic inertia and treat-to-target gap analyses.
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
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.
Validating non-invasive tests and risk classification
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.
Disease progression evidence
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.
PRO instrument validation and effectiveness evidence in the new MASH treatment era
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.
Real-world treatment patterns across the new therapeutic landscape
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.
Cardiovascular risk and underrepresented populations in routine MASLD care
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.
Wherever your program is, there's a way in: a full evidence plan, a single study, or a conversation about what's possible.
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