Phoenix, Arizona  ·  Phase I–IV Trials

Where science
meets human
possibility.

ProtoOne Clinical Research is a dedicated clinical research site advancing breakthrough treatments through rigorous, compassionate, participant-centered trials.

100+
Trials Completed
98%
Retention Rate
800+
Participants Enrolled
ProtoOne Est. 2026
FDA Compliant Facility IRB Approved Studies Cardiovascular Research Metabolic Disorders CNS Studies Vaccine Trials GCP Certified Staff No Cost to Participants FDA Compliant Facility IRB Approved Studies Cardiovascular Research Metabolic Disorders CNS Studies Vaccine Trials GCP Certified Staff No Cost to Participants

A single site.
Singular focus.

Since 2026, ProtoOne Clinical Research has operated as an independent clinical research site in Phoenix, Arizona. Our singular purpose: connect promising therapies with the right participants and deliver the highest-quality trial data to our sponsors.

Unlike multi-site networks, our focused structure means principal investigators are hands-on throughout every study, and our dedicated coordinators become true partners to each participant from screening through follow-up.

FDA Compliant 21 CFR Part 11 electronic records and audit trails
GCP Certified All staff trained to current Good Clinical Practice
IRB Oversight All studies reviewed by accredited IRB
HIPAA Secure Encrypted data management and privacy protocols
Trial Enrollment by Year
Est. 2026

Full-spectrum clinical
trial services.

Protocol Feasibility

We evaluate your study design against our patient population, site capabilities, and operational capacity to ensure successful execution before a single patient is enrolled.

Patient Recruitment

Our community-embedded recruitment strategies and proprietary database of 12,000+ pre-qualified participants consistently deliver faster enrollment and lower screen failure rates.

Regulatory & IRB Support

Our experienced regulatory team manages all submissions, amendments, safety reports, and correspondence with institutional review boards, keeping your study on schedule.

Data Management

Real-time EDC entry, query resolution within 24 hours, and comprehensive audit trails ensure your data meets the highest standards for regulatory submission.

Pharmacovigilance

24/7 medical monitoring, expedited SAE reporting, and dedicated safety physician oversight safeguard participant well-being throughout your trial lifecycle.

Sample & Lab Processing

On-site CLIA-certified laboratory for biomarker analysis, PK sampling, and specimen management, with established relationships with major central labs nationwide.

Currently enrolling studies.

Request information →
01
Cardiovascular Risk Reduction in Type 2 Diabetes
Evaluating a novel GLP-1/GIP dual agonist for CV outcome reduction in adults with T2D and established cardiovascular disease.
Phase III Enrolling Now
02
Non-Alcoholic Steatohepatitis (NASH) Treatment
Randomized, double-blind placebo-controlled trial of a FXR agonist in adults with biopsy-confirmed NASH and fibrosis stage F2–F3.
Phase II Enrolling Now
03
Migraine Prevention — Monthly Injectable
Evaluating efficacy and safety of a long-acting CGED antagonist for episodic and chronic migraine prevention in adults.
Phase III Screening
04
Hypertension — Fixed-Dose Combination Tablet
A bioequivalence study comparing a novel triple-combination antihypertensive tablet to individual components in adults with Stage 2 hypertension.
Phase I/II Screening
05
Insomnia — Non-Benzodiazepine Sleep Aid
Safety and efficacy evaluation of a selective orexin receptor antagonist in adults aged 22–65 with chronic onset insomnia.
Phase II Coming Soon

The ProtoOne participant journey.

1
Pre-Screening
Complete a brief online or phone questionnaire to check initial eligibility.
2
Screening Visit
Comprehensive medical evaluation, labs, and informed consent at our facility.
3
Enrollment
If eligible, you're enrolled and matched to the study arm by randomization.
4
Active Study
Regular study visits, monitoring, and constant support from your care team.
5
Follow-Up
Safety follow-up visits after treatment with comprehensive end-of-study care.

Why Choose ProtoOne

98%
Participant retention rate across all completed Phase II–IV trials
18 days
Average time from contract execution to first patient in
0 FDA
Warning letters or Form 483 observations since opening in 2026
95%
Sponsor renewal rate — sponsors return study after study

Trusted by sponsors.
Loved by participants.

Working with ProtoOne was the smoothest clinical research site experience we've had in 12 years of drug development. Their data quality is extraordinary and they beat our enrollment projections by 40%.

TM
Theresa Mallory, PhD
VP Clinical Operations, NovaBiologics Inc.

The team behind every trial.

RY
Ronald Yunis, MD
Principal Investigator
Principal Investigator with deep expertise in metabolic and cardiovascular research, leading ProtoOne's clinical programs since 2008.
JW
Jason Wallace
Chief Executive Officer
Leads ProtoOne's strategic vision and sponsor partnerships, with 15 years of experience scaling clinical research organizations.
SM
Sara Mathis
Chief Operating Officer
Oversees day-to-day operations, regulatory compliance, and staff development across all active studies at ProtoOne.
ED
Elizabeth Delgado
Site Manager
Coordinates study logistics, participant scheduling, and vendor relationships — keeping every trial running on time and on protocol.

Ready to partner
or participate?

Whether you're a sponsor seeking a high-quality site, a patient interested in clinical trial participation, or a referring physician, we're here to help.

📍
Location 1108 W Indian School Rd
Phoenix, AZ 85013
📞
Phone (602) 555-0184
✉️
Email info@protooneclinical.com
🕐
Hours Monday – Friday, 7:00 AM – 6:00 PM
Saturday by appointment