Clinical and Regulatory
Development
Clinical Research Unit
Clinical Research
Organization
Participant and
Site Services
Clinical Research
Institute
Clinical and Regulatory Development (CRD)The decisions made at the earliest stages of clinical development shape everything that follows. We engage with clients before a program is formally underway, clarifying the science, regulatory pathway, and strategic options needed to build the strongest possible foundation.
Our CRD team works alongside clients to shape development strategy, refine study design, and navigate the regulatory landscape, bringing scientific depth that supports more informed decisions from day one.
Our CRD services include:
Clinical Research Unit (CRU)Our in-house clinical research unit has been at the forefront of early metabolic disease research since 2003. With a 30,000 sq ft facility, up to 45 beds, 15+ glucose clamp beds, a CLIA-certified laboratory, and 24/7 on-site medical and clinical teams, it is designed for the complexity and rigor this work demands. From first-in-human through early-phase studies, clients benefit from our direct to participant access, faster startup, and a team with deep expertise in this science.
Our CRU has conducted 425+ clinical studies, and that experience is reflected in every engagement.
What distinguishes this unit is the complexity of the work it takes on. Automated glucose clamp studies, stable isotope tracer studies, and biopsy procedure studies are routine here, alongside advanced metabolic phenotyping and intensive PK/PD sampling that few early-phase units are equipped to deliver.
Our CRU services include:
Clinical Research Organization (CRO)Full-service clinical trial execution on a global scale requires more than operational capability. It requires genuine expertise in the diseases being studied. The same metabolic fluency that drives our clinical research unit shapes how we run trials at scale. The complex methods our CRU has mastered are the same methods our CRO knows how to plan and deliver across multi-center studies, whenever a trial calls for them. Our team manages execution from proactive planning at study start through feasibility, start-up, site selection, and monitoring to final database lock, clinical study report and trial master file completion and transfer. With access to a network of 250+ clinical sites and 55 method hubs, supported by strategic regional partnerships worldwide, ProSciento brings disease-area expertise to every level of delivery. All services are delivered through a single, integrated point of contact under an individualized, fit-for-purpose governance model.
Our CRO services include:
Participant and Site Services (PSS)Participant recruitment is a relationship, not a logistics exercise — and we built ProSciento around that conviction. Our proprietary participant registry is constantly growing, today spanning 180,000+ participants across the United States with 200+ metabolic characterization data points each. It was developed deliberately, to close longstanding gaps in recruitment and retention across metabolic disease research. But the registry is only part of the story.
What truly sets our PSS capability apart is the genuine, ongoing engagement we maintain with participants and sites across the metabolic continuum. These long-term relationships extend well beyond any single study, and for sponsors they translate into scientific productivity: feasibility assessments grounded in real participant data rather than projections, enrollment plans that hold to timeline and budget, active traffic control that routes each participant to the site best equipped to run them, and the ability to identify and de-prioritize low-yield sites before they consume months of study time. The result is fewer surprises, faster enrollment, and stronger retention across the life of the program.
Our PSS capabilities include:
Clinical Research Institute (CRI)At ProSciento, the science never stands still. Our Clinical Research Institute reflects a continued commitment to the field that extends beyond client work, and a genuine passion for the academic and scientific questions behind metabolic disease.
Through peer-reviewed publications, translational research, editorial leadership of an international scientific journal, and co-authorship of a leading textbook in the field, our team takes an active part in the scientific conversation around metabolic disease. We are not an academic center, but we stay close to the science — and that participation directly informs how we design studies, apply methodologies, and bring current scientific thinking to every client engagement.
Our CRI contributions include:
Clinical and Regulatory Development (CRD)The decisions made at the earliest stages of clinical development shape everything that follows. We engage with clients before a program is formally underway, clarifying the science, regulatory pathway, and strategic options needed to build the strongest possible foundation.
Our CRD team works alongside clients to shape development strategy, refine study design, and navigate the regulatory landscape, bringing scientific depth that supports more informed decisions from day one.
Our CRD services include:
Clinical Research Unit (CRU)Our in-house clinical research unit has been at the forefront of early metabolic disease research since 2003. With a 30,000 sq ft facility, up to 45 beds, 15+ glucose clamp beds, a CLIA-certified laboratory, and 24/7 on-site medical and clinical teams, it is designed for the complexity and rigor this work demands. From first-in-human through early-phase studies, clients benefit from our direct to participant access, faster startup, and a team with deep expertise in this science.
Our CRU has conducted 425+ clinical studies, and that experience is reflected in every engagement.
What distinguishes this unit is the complexity of the work it takes on. Automated glucose clamp studies, stable isotope tracer studies, and biopsy procedure studies are routine here, alongside advanced metabolic phenotyping and intensive PK/PD sampling that few early-phase units are equipped to deliver.
Our CRU services include:
Clinical Research Organization (CRO)Full-service clinical trial execution on a global scale requires more than operational capability. It requires genuine expertise in the diseases being studied. The same metabolic fluency that drives our clinical research unit shapes how we run trials at scale. The complex methods our CRU has mastered are the same methods our CRO knows how to plan and deliver across multi-center studies, whenever a trial calls for them. Our team manages execution from proactive planning at study start through feasibility, start-up, site selection, and monitoring to final database lock, clinical study report and trial master file completion and transfer. With access to a network of 250+ clinical sites and 55 method hubs, supported by strategic regional partnerships worldwide, ProSciento brings disease-area expertise to every level of delivery. All services are delivered through a single, integrated point of contact under an individualized, fit-for-purpose governance model.
Our CRO services include:
Participant and Site Services (PSS)Participant recruitment is a relationship, not a logistics exercise — and we built ProSciento around that conviction. Our proprietary participant registry is constantly growing, today spanning 180,000+ participants across the United States with 200+ metabolic characterization data points each. It was developed deliberately, to close longstanding gaps in recruitment and retention across metabolic disease research. But the registry is only part of the story.
What truly sets our PSS capability apart is the genuine, ongoing engagement we maintain with participants and sites across the metabolic continuum. These long-term relationships extend well beyond any single study, and for sponsors they translate into scientific productivity: feasibility assessments grounded in real participant data rather than projections, enrollment plans that hold to timeline and budget, active traffic control that routes each participant to the site best equipped to run them, and the ability to identify and de-prioritize low-yield sites before they consume months of study time. The result is fewer surprises, faster enrollment, and stronger retention across the life of the program.
Our PSS capabilities include:
Clinical Research Institute (CRI)At ProSciento, the science never stands still. Our Clinical Research Institute reflects a continued commitment to the field that extends beyond client work, and a genuine passion for the academic and scientific questions behind metabolic disease.
Through peer-reviewed publications, translational research, editorial leadership of an international scientific journal, and co-authorship of a leading textbook in the field, our team takes an active part in the scientific conversation around metabolic disease. We are not an academic center, but we stay close to the science — and that participation directly informs how we design studies, apply methodologies, and bring current scientific thinking to every client engagement.
Our CRI contributions include:
