NASH PASS is a clinical research platform providing healthcare providers and clinical trial sites the tools, methodology, and support to diagnose and monitor at-risk patients for the progression of fatty liver disease and nonalcoholic steatohepatitis (NASH). The program also provides qualified principal investigators and diagnosed patients the opportunity to participate in clinical trials investigating new NASH drug candidates. For sponsors, NASH PASS is highly effective in optimizing I/E criteria, substantially improving patient access and enrollment, and streamlining site selection for NASH clinical trials.
How Does Nash Pass Accelerate
Investigational Drug Clinical Trials?
NASH PASS is a powerful platform to improve enrollment and site selection for NAFLD and NASH clinical trials. The NASH PASS patient registry compiles real-time and longitudinal data for prescreened patients ready for enrollment and prequalified sites ready for an expedited study launch. For study sponsors, the benefits include optimized I/E criteria utilizing a sample data set; streamlined site selection; study start within three months; and front-loaded enrollment for the first three months to significantly improve overall study timelines.
NASH PASS Impact on Timelines, Cost and Enrollment:
Industry vs. NASHPASS
Typically 6 MONTHS
Often site selection is extended to outside the US for added patient access, increasing cost and time.
1 MONTH utilizing NASH PASS sites in the US, thereby reducing associated regulatory costs.
Industry vs. NASHPASS
Site selection alone is generally 4 MONTHS.
Prequalified sites in NASH PASS registry ready for immediate start and all sites screening in < 3 MONTHS.
Industry vs. NASHPASS
DELAYS due to enrollment difficulties and resulting protocol amendments, often to adjust I/E criteria.
Front-load enrollment in first 3 months.
100% ENROLLMENT on time when utilizing NASH PASS for I/E parameters.
Become a NASH PASS Strategic Site Partner
NASH PASS is an IRB-approved clinical protocol that provides clinical trial sites and healthcare providers the tools, methodology, and support to diagnose and monitor at-risk patients for the progression of NAFLD and NASH. The NASH PASS program also provides qualified principal investigators and diagnosed patients the opportunity to participate in clinical trials investigating new NAFLD and NASH drug candidates.
Information About NASH PASS for Patients
Fatty liver disease, even in its more severe form, is often a silent disease and many patients are not aware of their condition. This makes diagnosing fatty liver disease a challenge. Effectively treating the condition is also a challenge, as there are currently no FDA-approved medicines available to treat fatty liver disease. The good news is that there are many ongoing clinical trials for new therapeutics, which may provide opportunities for patients to access emerging innovative treatments and contribute to research to prevent and treat liver disease.
NASH PASS is a unique program that brings the clinical trial to your healthcare provider’s location so that patients at risk of developing fatty liver disease can obtain a diagnostic screening and learn about clinical trial opportunities in the comfort and convenience of their existing physician’s office. For information about locations that offer the NASH PASS screening program, please contact firstname.lastname@example.org.
Am I at Risk for Fatty Liver Disease?
¿Es Elevado Mi Riesgo de Presentar la Enfermedad de Hígado Graso?
Am I at High Risk of Developing Fatty Liver Disease?
Contact email@example.com for Information
on Locations That Offer the NASH PASS Screening Program
NASH PASS is a program created and managed by ProSciento, Inc., a leading clinical research organization widely recognized for nearly two decades of expertise in clinical trials for NASH, diabetes, and obesity, and contributions to the development of many life-improving, FDA-approved drugs and devices for metabolic diseases.
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