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Gastroenterology

Evidence that shapes decisions, not just supports them.

We partner with life sciences and health systems to deliver integrated gastroenterology evidence from clinical development to care delivery, supporting decisions at every stage.

World-class gastroenterology expertise

Crohn's DiseaseUlcerative ColitisEosinophilic GI Diseases (EGIDs)Celiac Disease

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.

6 years of GI 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

  • Clinical development

  • Translational and study teams

  • Program teams

  • Disease characterization, natural history, and feasibility informed by longitudinal cohort data with endoscopic, histologic, and PRO depth.

  • Protocol design and population selection grounded in real clinical contexts, including patient populations underrepresented in trials and the diagnostic patterns that determine when patients enter the treatment pathway.

  • Prospective studies and clinical trials run within Pedestal's cohort and site infrastructure.

  • External control arms.

  • Sub-phenotyping and risk stratification.

Approval & Commercialization Decisions

  • 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 across the expanding mechanism landscape.

  • Evidence on how endoscopic targets translate into long-term complication reduction.

  • Market access evidence on how patients receiving advanced therapy in routine practice compare to trial populations.

  • Publication strategy and support.

Care Decisions

  • Clinicians

  • Health systems

  • Care delivery teams

  • PI-led research

  • Treatment pattern characterization in routine practice across the full disease severity spectrum.

  • Long-term effectiveness and safety.

  • Clinical decision support evidence.

  • Therapeutic inertia and treat-to-target gap analyses.

  • Partnership infrastructure for clinician-led research and publications.

The same cohort. The same patients. Answering new questions about how to treat them better.

Three kinds of decisions, supported continuously as the IBD advanced therapy landscape transformed and treat-to-target frameworks became the standard of care.

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-IBD and TARGET-EGIDS appear in published literature and are referenced where relevant for scientific accuracy.

Foundational
R&D Decision

Cohort design and launch

Multi-site cohort designed and launched as a prospective longitudinal observational cohort of adult and pediatric IBD patients across academic and community US sites. Centrally abstracted electronic health records, quarterly PROs, and biospecimen infrastructure.

The substrate every later decision would draw on.

2020–2022
Approval & Commercialization and Care Decisions

Biologic patterns, histologic outcomes, and early versus late initiation

Biologic discontinuation patterns and predictors characterized across CD and UC. Treatment modification patterns characterized across moderate-to-severe UC patients on advanced and conventional therapies.

Histologic inflammation on index biopsy characterized as an independent predictor of loss of remission in UC patients with endoscopic remission — work that informs how endoscopic targets translate into longer-term outcomes. Impact of early versus late biologic initiation on Crohn's disease surgery and disease progression characterized.

2022–2023
Care Decision

Treat-to-target gaps and treatment journey mapping

Objective disease activity assessment and therapeutic drug monitoring practices characterized prior to biologic dose changes — quantifying the treat-to-target implementation gap in routine US gastroenterology care.

Outcomes of early versus delayed advanced therapy in moderate UC characterized, addressing a population frequently grouped with severe disease in trials. Treatment journey mapping in moderate UC published.

2024–2026
Approval & Commercialization and Care Decisions

Treat-to-target gaps and advanced therapy characterization with industry partners

Treat-to-target gaps quantified in both Crohn's disease and ulcerative colitis with Merck — characterizing the proportion of patients failing to achieve targets and the frequency with which therapy was escalated in response.

Impact of early endoscopic remission on long-term complications characterized in both UC and CD with Merck. Characterization of fistulizing Crohn's disease patients initiating risankizumab and upadacitinib in real-world practice with AbbVie.

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We're ready for what's next. Are you?

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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