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Metabolic Dysfunction-Associated  Steatohepatitis (MASH) Trial Solutions

Enhancing study success with advanced clinical research technologies and expert solutions for MASH trials.

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Delivering high-quality evidence in complex MASH clinical trials

Metabolic dysfunction-associated steatohepatitis (MASH), formerly nonalcoholic steatohepatitis (NASH), is an advanced form of steatotic liver disease that causes inflammation and may progress to fibrosis and cirrhosis without effective treatment. With MASH prevalence projected to increase 63% by 2030, the need for new and better treatments is clear. However, MASH trials face distinct operational challenges: poor patient retention across 18+ month protocols, complex stratification by biopsy or imaging results, highly subjective histology scoring vulnerable to rater variability, and patient populations with multiple metabolic comorbidities. Signant's eCOA, RTSM, rater training, and patient engagement technologies, supported by specialized MASH scientific expertise, address these specific challenges to generate regulatory-grade evidence across global trials.

Why Signant Health

  • Collect Accurate Data
  • Keep Patients Engaged
  • Ensure Ratings Consistency
  • Support Remote Visits
  • Optimize Supply Continuity
  • Assess Cognitive Function
  • Collect Accurate Data

    Collect Accurate Data

    MASH studies rely on sensitive histologic, imaging, and symptom endpoints where even small inconsistencies can obscure a treatment signal. SmartSignals eCOA digitalizes liver‑related assessments and validated PROs, time‑stamps every entry, and eliminates manual transcription so sponsors get complete, high‑quality data ready for regulatory review.

  • Keep Patients Engaged

    Keep Patients Engaged

    Long MASH trials demand sustained participation despite frequent visits, biopsies, and lifestyle requirements. Signant's patient engagement tools such as assessment completion reminders, study visit schedules, and video visits - all available within our ePRO app - make participation easier, improving adherence so fewer patients drop out before primary endpoints are reached.

     

  • Ensure Ratings Consistency

    Ensure Ratings Consistency Across Global Sites

    Liver histology scoring and key clinical assessments in MASH are highly subjective, making rater variability a major threat to endpoint reliability. Signant’s Rater Training and Central Rating programs qualify and calibrate raters before first patient in, provide ongoing performance monitoring, and use expert central reviewers where needed so your ClinRO and biopsy‑based endpoints remain consistent, defensible, and submission‑ready across all sites.
     
     
     

  • Support Remote Visits

    Offer Remote Participation

    Many MASH patients face travel and mobility barriers, yet trials still require frequent data collection over 18+ months. Signant supports hybrid and decentralized visit models with remote assessments, tele-visit capabilities, electronic informed consent, and direct‑to‑patient medication options, reducing site burden while keeping high‑value endpoints flowing between in‑clinic and at‑home visits.

  • Optimize Supply Continuity

    Optimize Randomization & Supply Continuity

    MASH protocols often involve complex dosing, long treatment periods, and stratification by biopsy or imaging results, creating risk of stock‑outs and waste. SmartSignals RTSM automates randomization, balances treatment arms, and optimizes inventory across global sites—supporting at‑home and in‑clinic dispensing—to ensure every eligible patient receives the right medication on time without oversupplying low‑enrolling locations.

  • Assess Cognitive Function

    Assess Cognitive Function

    Incorporate computerized cognitive assessments to detect subtle changes and clearly see how your MASH treatment affects brain function. Our validated, highly sensitive, disease‑agnostic solution precisely measures key cognitive domains—attention, information processing speed, executive function, and both episodic and working memory—giving sponsors confident, quantifiable insights into cognitive outcomes.

Proven global MASH experience

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Electronic Clinician Ratings


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Driving High Quality ClinRO Data with Rater Training & Qualification

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Key solutions for optimized MASH trials

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Discover how Signant's specialized solutions can address unique challenges in your current or upcoming MASH protocols.

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