Capabilities
Clinical trials evaluating new treatments for metabolic diseases in the heart of Los Angeles.
We conduct outpatient clinical trials in obesity, diabetes, metabolic liver disease, and related conditions. Our physician-led institute brings together therapeutic expertise, purpose-built research space, and strong access to diverse populations across Los Angeles County.
Therapeutic Expertise in Metabolic Disease
A clinical trial is a research study that helps show how a treatment works, including its safety and effectiveness. Trials are an important part of the process for bringing new treatments to people and for learning more about treatments already in use. Each trial follows a pre-approved study plan and set of rules, is reviewed by an independent ethics board, and must meet federal research standards. Before joining, people receive clear information about what the trial involves, such as the number of visits, how long the trial lasts, and the treatment being studied. There is no cost to participate, and trials include compensation for their time. Joining a trial is always a choice, and it may offer a way to contribute to future treatments for people living with similar conditions.
Experienced Phase 2–4 Trial Execution
Our team manages all aspects of Phase 2–4 outpatient trial operations, including screening, randomization, investigational product handling, safety assessments, and protocol-required procedures. All studies are conducted under strict regulatory and ethical oversight. Our principal investigator, with the support of experienced sub-investigators, provides ongoing medical oversight throughout each study, ensuring timely safety review and protocol guidance.
Regulatory Affairs & Study Oversight
Our institute maintains full regulatory preparedness to support high-quality Phase 2–4 clinical trials. All regulatory submissions and site documentation are managed centrally, ensuring accuracy, consistency, and compliance throughout the life of each study. We prepare and maintain all essential regulatory documents—including FDA Form 1572, financial disclosures, delegation logs, training records, CVs, licenses, and laboratory certifications—within our validated electronic regulatory system.
We support sponsors and CROs through timely completion of feasibility questionnaires, rapid document turnaround during study start-up, and ongoing maintenance of inspection-ready files. Our team adheres to ICH-GCP, FDA regulations, and IRB requirements, with continuous oversight by our principal investigator. During active trials, we ensure prompt reporting of safety events, protocol deviations, and regulatory communications, supported by transparent, consistent documentation practices.
This dedicated regulatory capability helps reduce sponsor burden, shortens activation timelines, and ensures every study remains compliant, well-documented, and fully audit-ready.
Our team works efficiently with central IRBs, supporting streamlined start-up timelines and consistent regulatory communication for multi-center studies.
Participant Recruitment & Community Outreach
Our location in Downtown Los Angeles provides strong access to adults living with common metabolic conditions. Recruitment is supported through a large and growing internal database, community outreach across Los Angeles County, relationships with local healthcare providers, bilingual communication in English and Spanish, and targeted digital and traditional advertising. We focus on reaching individuals who may not have had prior opportunities to participate in clinical research, helping ensure that study enrollment reflects the real-world populations most affected by the conditions being studied.
We are committed to enrolling participants who reflect the racial, ethnic, and socioeconomic diversity of Los Angeles, supporting more generalizable, real-world data for metabolic therapies.
Advanced Research Infrastructure
Our institute includes more than 5,000 square feet of dedicated clinical research space, with multiple exam rooms, a research laboratory for point-of-care testing and sample processing, secure medication storage, continuously monitored cold storage, and designated sponsor monitoring areas.
Clinical Assessment Capabilities
Our facility supports the full range of assessments required for Phase 2–4 trials, including point-of-care testing, sample processing, vital signs, and ECGs, all performed by trained clinical and laboratory personnel. We also provide on-site FibroScan (VCTE) for noninvasive assessment of liver stiffness and steatosis, supporting efficient screening and follow-up in metabolic liver disease studies. Additional protocol-required procedures—including imaging, specialty laboratory testing, eye exams, sleep evaluations, and other specialty referrals—are coordinated to ensure smooth visit flow and high-quality data collection.
Hospital-Campus Access
Located on the campus of Dignity Health – California Hospital Medical Center, the Institute has convenient proximity to hospital-based services that support trial-related needs, including imaging, specialty laboratory testing, and other protocol-required procedures.
Emergency services are immediately adjacent for urgent evaluation if needed.
This location enhances participant convenience and supports efficient trial operations.
Quality & Compliance
All trials at the Institute follow strict regulatory and ethical requirements supported by comprehensive standard operating procedures. Our clinical team is trained in Good Clinical Practice, experienced in safety reporting and protocol adherence, and committed to maintaining complete and accurate study documentation. We work closely with sponsors and CROs to ensure transparent communication, high-quality data, and dependable study performance from start to finish.
Technology & Data Infrastructure
The Institute uses fully electronic research systems, including eReg, eConsent, and eSource through CRIO, supporting efficient workflows, real-time data entry, and remote monitoring when needed. All digital systems incorporate controlled access, audit trails, secure data storage, and continuous backup. Our IT infrastructure includes robust data-protection measures and professional monitoring to support reliable, inspection-ready operations throughout every study.
These systems support remote monitoring, risk-based monitoring, and seamless collaboration with sponsors and CROs.
Pharmacy & Investigational Product Management
The Institute maintains secure, temperature-controlled storage for investigational products, including ambient and refrigerated medications, with continuous temperature monitoring and documented accountability. Designated staff oversee IP receipt, storage, preparation, and dispensing in accordance with protocol requirements and regulatory standards. A pharmacy located within the Loker Medical Arts Pavilion provides convenient access for medication-related needs that support trial operations when required.
Participant Support Services
Participant-support services help ensure smooth study participation and adherence. This includes access to a contracted dietitian with extensive experience in obesity and metabolic clinical trials, providing nutrition guidance when required by study protocols.
Additional support resources—such as bilingual communication, coordinated scheduling, assistance with referrals, and dedicated reminder systems—help create a positive participant experience and support reliable visit adherence across all phases of a study.
This includes nutrition guidance and behavioral support for metabolic and obesity-related studies when required by protocol.
Our Facility
Purpose-built space for high-quality clinical research.
Our 5,000+ square foot research center features dedicated exam rooms, a research laboratory, secure investigational product storage, sponsor monitoring space, and comfortable participant areas. Being located on a major hospital campus makes our institute accessible to people throughout Los Angeles.
Participant comfort is prioritized through dedicated waiting areas, private exam rooms, and streamlined visit flow designed for outpatient clinical research.
“By taking part in a clinical trial, people with common metabolic conditions may gain access to new treatment options and help develop future therapies to better manage and potentially prevent these conditions in Los Angeles and beyond.”
Juan Pablo Frías, M.D.
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