Science-Driven Solutions for NASH

12+

Years of experience designing and conducting NASH clinical trials

Leading Provider

More early phase NAFLD and NASH clinical trials conducted than any other US provider*

*Data from lnforma’s Citeline December 2021

4,500+

Prescreened, diagnosed, research-ready patients

Driving advances in NASH clinical research

Therapeutic expertise isn’t just important, it is critical for complex NASH clinical trials. With unparalleled NASH trial experience, ProSciento’s proven, science-driven strategies, and specialized services benefit our clients, while also advancing research in biomarker discovery and disease progression.

ProSciento’s NASH Ecosystem

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New paradigm in patient diagnosis and engagement

ProSciento’s NASH PASS® is a diagnostic clinical study protocol, platform, and NASH patient database that provides clients access to research-ready patients and prequalified sites for expedited start of their NAFLD/NASH clinical studies. The NASH PASS infrastructure and biobank are also serving as a powerful platform for collaborative translational research within the research community.

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Novel Methodology Advancing Clinical Study Design and Enrollment

ProSciento’s NASH PASS proprietary diagnostic patient phenotyping and access program is highly differentiated from what multi-therapeutic CROs can provide. The NASH PASS, IRB-approved study protocol significantly accelerates site selection and patient enrollment for NAFLD/NASH clinical trials. The NASH PASS patient database is also utilized in study design to tailor study enrollment projections, feasibility analysis, and optimization of I/E criteria, resulting in significantly reduced screen fails, avoiding delays in enrollment, and providing reliable project study timelines.

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Network of NASH PASS Clinical Trial Sites, Ready for Immediate Start

ProSciento has cultivated relationships with investigational sites that can contribute at-risk patients for inclusion in ProSciento’s NASH PASS program, where they will undergo phenotyping per the NASH PASS protocol and can be pre-screened for specific interventional study protocols. For NAFLD/NASH clinical trial enrollment, this means access to a large population of diagnosed, research-ready patients at pre-qualified sites ready for an expedited start. Moreover, patients screened and diagnosed via NASH PASS screening are reserved for NASH PASS-client studies, eliminating competing protocols within a site.

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Utilizing NASH PASS for Biomarker Discovery and Translational Research

The NASH PASS infrastructure and biobank are important and evolving platforms for translational research partnerships to advance scientific knowledge of NAFLD, NASH, and metabolic-related fibrotic disease pathology and progression, as well as the development of novel biomarkers for clinical research. Scientists and clinical development experts interested in biomarker discovery and validation, endpoint determination, and the study of NAFLD/NASH as a multi-system disorder can contact bd@prosciento.com for more information on collaborative research opportunities.

Learn more about NASH PASS at www.nashpass.com.


Clinical Research Site Access to Advanced Methods

ProSciento’s Hub & Spokes™ infrastructure brings together a global network of clinical trial sites and specialized method hubs to ensure site and patient access to advanced methods and technologies, including imaging, circulating biomarkers, and tissue biopsies procedures for the conduct of complex clinical trial programs. ProSciento manages the relationship between clinical trial sites and specialized method hubs, allowing for maximized efficiencies at site and client levels.

250+

Clinical Trial Sites

55+

Advanced Method Hubs

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HUBS
Centers with Advanced Methods to Support Complex Clinical Trial Programs

ProSciento has a network of method hubs that are specialized centers with capabilities in advanced technologies and procedures, such as cutting-edge imaging, circulating biomarkers, and tissue biopsies. These advanced method hubs are strategically located around the world so that they are within close geographic proximity to clinical trial sites to ensure access for sites and patients.

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SPOKES
Global Network of Sites with Expertise in Clinical Trials for Metabolic Diseases

ProSciento manages the relationship between clinical trial sites and specialized method hubs. To ensure efficiencies for complex multi-site NASH studies, clinical trial sites are selected within geographic proximity of pre-qualified method hubs. This removes the burden from individual sites to procure access to specialized methods. This also broadens the number of sites that can participate in a study and increases access to patients who may be eligible to participate in those trials.


Global expertise in research and clinical development for metabolic fibrotic diseases

The NASH Roundtable consists of distinguished physicians, researchers and clinical development experts from three continents brought together by their common commitment to steward advances in science, clinical research and effective therapies for NAFLD, NASH, and related metabolic-related fibrotic diseases.

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Coalition for Collaborative Science

The NASH Roundtable was established in 2018 to accelerate the advancement and application of scientific methods and strategies for NASH and the continuum of related metabolic clinical research. Roundtable members represent cross-functional expertise in fibrotic disease research, drug development, and patent care, and hail from prominent academic and medical centers.

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Access to Pre-Screened Patient Biobank

Because collaborative research is a critical focus, NASH Roundtable members have access to the NASH PASS database and biobank as a powerful platform to advance biomarker discovery and validation, endpoint determination, and the study of NAFLD/NASH as a multi-system disorder. The NASH PASS diagnostic and research platform utilizes Fibroscan imaging, laboratory testing, and proprietary algorithms to identify patients with NAFLD and those at high risk for NASH. As a result of the optimized screening, there is an abundance of data and biological specimens. These data allow for the opportunity to help expedite clinical research and help move the field forward. 

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Bridging Academics and Pharma Industry

NASH Roundtable members are accessible to biopharma to consult on NASH development programs, including:

  • Clinical development and regulatory planning
  • Clinical and pre-clinical study design
  • Biomarker strategies
  • Applicable and relevant clinical research methods
  • Asset evaluation and risk assessment
  • Competitive and scientific landscape review

The NASH Roundtable also hosts forums twice a year to coincide with the EASL and AALSD Liver Conferences. As of 2021, a select group of biopharma guests is also invited to attend the forums. For more information or to inquire about attending a NASH Roundtable event, please contact nashroundtable@prosciento.com.

Learn more about the NASH Roundtable members and events at www.nashroundtable.com


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