Together We Make a Difference

Science-driven Metabolic Experience Differentiates Our Services

Unparalleled Metabolic Expertise

Our services feature broad scientific expertise, direct patient access, advanced methodologies, and global operations that are exclusively focused on diabetes, NASH and obesity to support our clients’ commitment to improving human health. Our understanding of metabolic disease and methods to accelerate drug and device development are proven, measurable, and showcased in our CRO services covering phase 1 through specialized phase 3 clinical trials.

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Physicians collaborating

Right-sized To Accelerate Your Clinical Trial Programs

We are a team of global scientific and operational experts within a right-sized, nimble organization able to accelerate programs for our clients, while the focus of our therapeutic expertise in metabolic diseases allows for a deep understanding of client development needs. Each of our clients is important to us, no matter the size of their pipeline, and receives the same level of dedicated attention from specialized and experienced professionals.

Data-driven Patient Engagement Strategies

We have developed differentiating programs for improved access to patients, especially for complex, difficult-to-recruit clinical trials, utilizing a specialized patient engagement platform and our relationships with clinical research sites worldwide. This platform ensures that our clinical studies are enrolling eligible patients at the most qualified sites and engaging with the study participants throughout the study and beyond.

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Solutions For Multinational Clinical Trial Programs


Specialized Single-site Studies

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Full-scope, comprehensive CRO services to support single or multi-site, multinational metabolic clinical research programs.

  • Early and late-stage development protocol analysis and planning
  • Global network of 220+ clinical trial sites
  • Centralized recruitment and proven patient access and engagement strategies
  • Comprehensive and proven methodologies for feasibility
  • 55+ advanced methods centers, including specialized imaging
  • Global clinical trial management and monitoring teams
  • Data management and biostatistics
  • Physician support, medical monitoring and pharmacovigilance
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Specialized, state-of-the-art clinical research unit established in 2003 in Southern California and globally recognized for metabolic drug and device clinical trials.

  • First-in-Human, First-in-Patient studies
  • Single Ascending Dose (SAD), Multiple Ascending Dose (MAD) studies
  • Proof of Concept (PoC), Proof of Mechanism (PoM), Mechanism of Action (MoA) studies
  • Bioequivalence and drug/drug interaction studies
  • Full spectrum of automated glucose clamp studies
  • 21,000 sq ft and 30+ treatment beds
  • Eight-week in-patient extended stay capabilities
  • CLIA-certified laboratory
  • USP 797/800 standard clean room
  • 24/7 on-site medical and clinical teams
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CRD logo

Clinical development and regulatory services to support clients of all sizes optimize their drug development strategy and focus investments on the most promising compounds.

  • Target product profiles and clinical development planning
  • Study design and inclusion/exclusion (I/E) modeling
  • Protocol development
  • U.S. and EU regulatory strategies and management
  • Scientific advisory board management
  • Licensing opportunities
  • Medical writing
  • Presentation development and abstract submissions for medical conferences and journals
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CRI logo

Comprehensive repertoire of sophisticated methods and services to optimize clinical trials for metabolic diseases, well beyond what is offered by traditional CROs.

  • Advanced imaging
  • Circulating biomarkers
  • PK/PD modeling
  • Specialty labs and assays
  • Global network of partners with complementary research methods
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Explore Our Full Scope Science-driven Services

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Clinical Development Consulting

ProSciento’s Clinical Development services are tailored to the specific needs of our clients and typically begin with a well-defined target product profile and clinical development plan. Clients work with our team of seasoned professionals, comprised of PhD and MD level scientists with extensive track records in metabolic drug and device development, at every step of the process from early development planning through regulatory submissions and licensing opportunities.

Clients often choose to partner with ProSciento because of the depth and scalable nature of our clinical development services, combined with deep scientific and therapeutic expertise in metabolic diseases—providing distinct advantages for this early stage of compound strategy and development.

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Study Design & Protocol Development

ProSciento’s Study Design and Protocol Development team is a recognized leader in developing protocols for first-in-human metabolic clinical trials.  ProSciento is asked to contribute scientifically to nearly all study protocols and often provides full protocol development for its clients’ clinical drug and device programs, which includes later stage trials.

ProSciento’s team of highly experienced clinical development experts have longstanding expertise in developing protocols for metabolic programs, have in-depth knowledge of primary and secondary endpoints, and, most importantly, help clients steer clear of common challenges, such as unnecessarily complex study protocols, which can slow the development process and drive up costs.

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Regulatory Affairs

ProSciento’s therapeutic-specific scientific and regulatory expertise provides a distinct advantage in navigating the evolving global regulatory environment. Our Regulatory Affairs services typically begin with assessing IND readiness, analyzing regulatory options, and researching marketing opportunities afforded by each regulatory path, with a keen focus on evaluating where the product best fits into the standards of care for metabolic disease and what is needed from clinical and regulatory perspectives to achieve this goal. ProSciento’s Regulatory Affairs Team then provides project management for all document creation, submission, and representation of the client at meetings with FDA and EMA regulatory agencies.

Our regulatory track record speaks for itself with contributions to 17 approved metabolic drugs and devices and more than 100 submissions to the FDA’s Metabolism and Endocrinology Products (DMEP) and Gastroenterology and Inborn Errors Products (DGIEP) Divisions.

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Patient Enrollment & Engagement

ProSciento provides its clients a significant advantage in patient access and enrollment via its PRO PASS™ diagnostic IRB-approved protocol deployed at sites across the nation and growing globally that provides detailed diagnostic data to aid in optimizing inclusion/exclusion (I/E) criteria and site selection based on patients that meet protocol eligibility.

ProSciento considers patient engagement and retention as a critical priority for all studies. Our Patient Recruitment and Retention team creates patient-centric, study-specific plans designed to optimize engagement throughout the patient’s journey in our clients’ studies. Our solutions leverage technology-based innovations, including automated text and email touchpoints, educational resources, and patient concierge services.

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Site Selection & Vendor Management

Selecting suitable sites with access to patients meeting protocol eligibility requirements is paramount to study enrollment success in clinical research. To bolster site selection, ProSciento has a strong global network of clinical trial sites and specialized vendors, curated over nearly two decades of expertise in metabolic clinical research. Additionally, ProSciento’s PRO PASS platform and database provide detailed diagnostic data to aid in optimizing I/E criteria and site selection based on patients that meet protocol eligibility. Overall, ProSciento’s depth and breadth of services help ensure streamlined site and vendor selection, improved enrollment, and accelerated study launch providing a dramatic and positive impact on the conduct of the entire study.

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Clinical Monitoring

ProSciento’s Clinical Monitoring team consists of CRA professionals with focused expertise in metabolic clinical studies. This model is different in the industry, in that our CRAs are not working across several therapeutic areas at once, thus promoting efficiency and focus. Our CRAs are critical to our overall clinical trial management team and implement effective monitoring and risk mitigation strategies, ensuring patient safety, data integrity, and risk assessment. For each study, the lead CRA is the primary point of contact—a best practice that eliminates confusion that sites sometimes face in wondering whom to contact. Moreover, ProSciento’s proprietary CRA Score Card system tracks key performance indicators, including turnaround time for onsite monitoring reports, percentage of SDV backlog, and resolution of Issues in Action, helping to drive site performance and providing real-time actionable reporting.

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Investigational Product Management

ProSciento has a dedicated Pharmaceutical Services (PS) group that takes a science-driven approach to IP Management.  The group consists of pharmacists and researchers with longstanding expertise in early-stage metabolic trials—more than 200 to date. In addition to IP logistics, preparation, and storage, the PS group provides seamless integration with drug depot services for IP distribution for multi-site clinical trials and is highly skilled at conducting isotope studies, with single and dual tracers, for early phase clinical trials. Read more about ProSciento’s IP management services.

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Data Management & Biostatistics

Good quality data are the backbone of a clinical trial as they determine if a study meets its primary and secondary endpoints. What further sets ProSciento apart is our team’s understanding of early-stage metabolic studies.  This informs how we build databases and the types of data we need to collect during both the early and later stages of a specific drug development program. Because our team members are certified, all database builds are in-house for speedier timelines and more flexibility due to fewer hand-offs throughout the study build process, saving weeks in database build time.  To enhance data quality, our team uses industry-best CDM, EDC, and CTMS systems, with a single access point for sites for data-driven metrics. Importantly, our data visualization tools give clients full transparency and custom reports of raw data and finished data in real-time. 

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Medical Monitoring & Pharmacovigilance

ProSciento’s Medical Monitoring and Pharmacovigilance (PV) teams bring an unmatched level of scientific and therapeutic area expertise to ensure data integrity, safety, and mitigate risk 24/7 by working closely with clients, sites, and regulators.  Our physicians have a keen understanding of how to interpret pre-clinical, clinical, safety, and pharmacokinetics data to support effective dose escalation and safety reviews, and provide valuable expert input into phase 1 to 3 clinical study design, inclusion/exclusion criteria, PD/biomarker strategy, and regulatory requirements. For efficiencies and enhanced data transparency, we utilize a fully E2B (R3) compliant cloud-based PV system to enable fast evaluation of reportability, generation of regulatory reports, and signal detection. 

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Specialized Methodologies

At ProSciento, we are committed to contributing to scientific discoveries and advancing clinical methods that support new therapeutic development worldwide. The breadth of our team’s expertise makes ProSciento a unique partner for the execution of sophisticated metabolic trials. Our proven expertise in specialized clinical methodologies include:

  • Automated glucose clamp
  • Stable isotope tracer methodologies
  • Imaging biomarkers
  • Circulating and functional biomarkers
  • Glucose, lipid, and mixed meal tolerance tests
  • Indirect calorimetry
  • Tissue biopsies
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In-Patient Extended Stay Capabilities

ProSciento’s specialized early phase Clinical Research Unit (CRU) accommodates extended in-patient studies up to eight weeks, supported by a 24/7 medical team. This capacity supports protocols for complex early phase metabolic trials, including extended glucose clamp studies.

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USP 797 Sterile Compounding

ProSciento’s drug compounding procedures strictly adhere to USP 797 thus ensuring the safety of clinical study participants and supporting the successful execution of clinical trials. ProSciento’s Clinical Research Unit (CRU) in Southern California has a state-of-the-art USP 797/800 clean room (positive/negative pressure/ante room), 24/7 storage temperature monitoring and alarm system, and secure, controlled access drug rooms.

Prosciento by the Numbers

19+

Years as the leading clinical research provider for metabolic diseases

350+

Clinical trials complete in diabetes, NASH & obesity, including 130+ trials in biologics

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Contributions to 17 approved metabolic drugs and devices

Unparalleled Experience

More phase 1/2 clinical trials conducted for type 1, type 2, and NASH than any other U.S. provider*

*Data from Informa’s Citeline December 2021

Every Drug Class

Clinical studies conducted in every medically relevant drug class in diabetes and NASH

300+

Peer-reviewed articles and scientific poster presentations reporting clinical trial data