An experienced investigator.
A patient base built in.
Rume Research is a physician-led research site in Irvine, California, embedded in a primary care network. We deliver reliable enrollment, clean data, and responsive communication from startup to close-out.
Site capabilities
Principal Investigator
Board-certified family physician with 30+ trials as PI, co-author of the outpatient convalescent plasma trial published in The New England Journal of Medicine
Patient access
Our research facility benefits from an extensive patient recruitment network through Rume Health and Elevated Health clinics, with locations in Irvine, Orange, Huntington Beach, Oceanside, and Redding, California. These established healthcare networks provide access to a broad and diverse patient population across multiple therapeutic areas. Additionally, our facility maintains an established patient database consisting of individuals with various medical conditions, including Type 1 and Type 2 diabetes, obesity, cardiovascular disease, metabolic disorders, and other chronic health conditions. Our recruitment strategies include targeted patient outreach, physician referrals, database prescreening, and community engagement initiatives. This integrated recruitment approach allows our site to efficiently identify potentially eligible participants, accelerate enrollment timelines, support diversity in clinical trials, and maintain strong participant retention throughout the study.
Diverse population
Orange County's diverse community, with recruitment support in English, Spanish, and Tagalog
Study types
Phase 2 and Phase 3 drug and vaccine trials; pivotal, usability, and OTC home-use diagnostic and device studies supporting FDA EUA, 510(k), and CLIA-waiver submissions
Quality
ICH GCP investigator training current through 2027; CITI and NIAID GCP certified
Startup
Startup: 2–4 weeks, depending on the study protocol, patient population, inclusion/exclusion criteria, and recruitment requirements or First Patient In (FPI)/Randomized: 2–4 weeks after activation. First Patient Screened (FPS): 1–2 weeks after activation.
Facilities
Experienced Investigators and Research Staff: Qualified Principal Investigators, clinical research coordinators, medical assistants, and trained support personnel experienced in conducting Phase II–IV clinical trials. Flexible Participant Scheduling: Accommodations for participant needs to improve recruitment, visit compliance, and long-term retention. Electronic Clinical Trial Systems: Experience with electronic data capture (EDC), electronic diaries, electronic patient-reported outcomes, and clinical trial technology. Regulatory and Quality Compliance: Experience with FDA regulations, ICH-GCP requirements, IRB submissions, informed consent, protocol deviations, safety reporting, and quality assurance. Investigational Product Management: Secure investigational product storage, temperature monitoring, accountability, dispensing, and documentation. Specialized Diagnostic Services: Coordination of MRI, DXA scans, echocardiograms, ophthalmology evaluations, and other specialized testing through qualified external facilities. Clinical Assessments and Procedures: Vital signs, ECGs, CLIA certified laboratory specimen collection and processing, physical examinations, medication administration, and protocol-specific assessments.
Therapeutic experience
Vaccines (adult & pediatric), obesity & weight loss, endocrine, infectious disease & antivirals, asthma & allergy, cardiovascular & renal, dermatology, neurology, and in-vitro diagnostics.
Sponsor experience
Our Principal Investigator has conducted studies for sponsors including Pfizer, Merck, Moderna, AstraZeneca, Novartis, GSK, Gilead, Sanofi, Eli Lilly, and Teva.