Orange County Research Center:

Where cutting-edge clinical trials meet compassionate care

We conduct all of our drug and medical device trials with the highest standards of precision, safety, and care

Who we are

Advancing medical science, one clinical trial at a time

For over 30 years, Orange County Research Center (OCRC) has been at the forefront of clinical research for drug and medical device development. Our commitment to excellence, patient safety, and scientific rigor has earned us the trust of pharmaceutical and medical device companies worldwide.

Our key strengths include:

Phase 1 Unit

Phase I Unit: Setting the standard for early-phase trials

Established in 2004, OCRC’s Phase I Unit is designed for early-stage trials, including first-in-human studies, bioavailability, and bioequivalence studies.

Features

Equipment

State-of-the-art on-site trial equipment for precision research

Our clinical research site is equipped with cutting-edge tools to meet diverse trial requirements.

Diagnostic and monitoring tools

Telemetry
Treadmill
Fibroscan
DEXA scan
ECG machines
Ultrasound
Echocardiography
Six-minute walk testing
24-hour ambulatory blood pressure monitoring (15 machines)

Laboratory and support equipment

Freezers and refrigerators (five total, including −80°C)
Continuous temperature monitoring tools
Refrigerated and ambient centrifuges
Strength testing devices (hand grip)
Infusion pumps
Weight scales

In-house procedures

Comprehensive in-house procedures for reliable data

OCRC enhances the efficiency and scope of clinical trials with a wide range of in-house procedures, including:

Fibroscan

Assesses liver fibrosis and steatosis

Ultrasound

Reviews abdominal, cardiac, and vascular structures and functions

Echocardiography

Evaluates heart structure and functions

Radial arterial lines

Provide continuous monitoring and accurate blood sampling for real-time physiological assessments

Treadmill stress testing

Assesses cardiovascular health and exercise capacity

Skin biopsy

Collects skin samples for dermatological evaluations and research

Muscle biopsy

Analyzes muscle tissue for diagnostic and research purposes

DEXA scanning

Measures bone density and body composition to assess risks of osteoporosis and other conditions

Unique and complicated protocols

Expertise in complex protocols

Our team specializes in conducting unique and complicated studies such as:

Long-term bed rest studies
Thorough QT studies
Holter monitoring studies
ABPM studies
NASH and MASH studies requiring liver biopsies
Studies requiring muscle biopsies
Studies requiring skin biopsies
Studies requiring placement of radial arterial lines
Studies requiring cold pressor testing
Food effect studies
In the process of developing the capabilities of performing euglycemic insulin clamp studies with in-house endocrinologist

Testing protocols

Specialized testing protocols for every study

OCRC has a large database of patients required for specialized testing protocols, including:

QT studies

Navigate the regulatory landscape with OCRC’s TQT expertise

Thorough QT (TQT) studies are a crucial step in new drug development. The Food and Drug Administration (FDA) mandates these studies to assess potential cardiac risks. With OCRC’s expertise, you can confidently navigate these complex regulatory requirements.

Proven track record

Over the past six years, OCRC has successfully conducted 10 TQT studies.

Comprehensive capabilities

Our team is experienced in studies requiring telemetry, Holter monitoring, and multiple ECG recording.

Device studies

Advancing the future of medical devices

OCRC evaluates innovative medical devices, including:

Multiple innovative wrist and finger continuous monitoring BP devices and comparing them to intra-arterial measurements for FDA submissions
Noninvasive glucose measuring devices
Measurement of arterial compliance
New insulin pump devices
Continuous glucose monitoring devices
Gastric PH capsule

Diversity in participants and staff

A diverse approach to clinical trials for inclusive results

Orange County and its neighboring counties have a highly diverse population, making them ideal for conducting inclusive clinical trials. Both the FDA and study sponsors emphasize the importance of representing diverse populations in clinical research to ensure that findings are applicable across different demographic groups.

The OCRC database reflects this diversity, with an approximate ethnic breakdown of:

This wide representation allows us to enroll diverse cohorts and even entire study groups from specific racial or ethnic backgrounds. Notably, our database includes a significant number of first-generation participants from Japanese, Chinese, Korean, and Filipino communities, enhancing the cultural and genetic breadth of our studies.

To support this diversity, our team is equally multicultural and multilingual, with staff fluent in:

Given our linguistic and cultural expertise, we can ensure clear communication and foster trust with participants from various backgrounds, enhancing the quality and reliability of our research outcomes.

Protocol review

Expert protocol review and guidance for seamless trials

OCRC has conducted over 2,000 Phase I–IV studies over the past 30 years, in which Joel M. Neutel, MD has served as the principal investigator. As a result, he frequently is asked to:

Review and comment on study protocols

Review study Informed Consents

Review comprehensive study reports

Serve as a Lead Investigator for the study program

At the sponsor’s request, present data from studies at medical conferences

Added value

Orange County Research Center’s added value to studies

OCRC brings unparalleled expertise and insights to every clinical trial. Here’s what sets us apart:

Protocol review expertise

We thoroughly review study protocols to optimize workflow within the clinical environment while ensuring the collection of all required data.

Informed Consent form (ICF) development

Our team reviews and creates clear, comprehensive ICFs, ensuring participants fully understand the study and their rights.

Source document creation

We develop detailed, customized source documents to facilitate accurate and consistent data capture.

Active participation in safety oversight

We play a vital role in DLRM safety meetings, providing valuable input to ensure participant safety throughout the study.

Lead investigator role

OCRC frequently serves as the lead investigator, coordinating efforts across multiple study sites to ensure consistency and adherence to study protocols.

Comprehensive study report (CSR) review

We are experienced in reviewing study CSRs and ensuring accurate and thorough documentation of study findings.

Document handling

Lightning-speed document handling for timely trial initiation

OCRC streamlines every aspect of trial setup so you can launch your clinical trials in a timely and efficient manner. We achieve this through:

Rapid document preparation and submission

Our regulatory team can prepare and submit documents within 24 hours.

Quick IRB approvals

OCRC works with central Institutional Review Boards (IRBs), enabling approval within 7 to 10 days.

Efficient contract and budget turnaround

Our contract and budget team delivers a swift turnaround, preparing essential documents within 24 to 48 hours.

Contract and budget negotiations run parallel to regulatory activities, ensuring no time is lost.

Expertise in study platforms

Our site team has extensive experience with study platforms such as SIP, Florence, Impala, Inform, Imedidata Rave, Firecrest, and Greenphire, allowing immediate site registration and use upon access.

Start-up activities

Streamlined start-up activities for faster trial activation

Why us for recruitment and phase 1

Recruitment and enrollment expertise

OCRC is consistently recognized as one of the top recruiting sites, thanks to our robust, strategic approach to patient recruitment and enrollment. Here’s how we excel:

Multilingual, experienced recruiting team

Our dedicated, multilingual recruiting team brings years of experience in prescreening and enrolling patients for Phase I–IV clinical trials.

Comprehensive recruitment tools

We leverage a variety of recruitment channels, including a highly curated patient database, social media platforms (Facebook, Clinical Connection, Instagram), targeted advertising (newspapers, radio), and flyer distribution, to reach diverse patient populations.

Strong physician relationships

OCRC has cultivated strong relationships with local physicians within a 10-mile radius, who often refer eligible subjects to our facility, ensuring a steady stream of potential candidates.

Diverse and well-characterized patient base

We maintain a healthy volunteer patient base of approximately 7,500 normal volunteers. Our patient database is meticulously characterized by demographics, enabling us to quickly identify top candidates through protocol-specific queries.

Commitment to patient retention and reliability

We invest significant effort in assessing patient reliability and ensuring retention throughout studies, building trust with participants to guarantee high-quality data.

Efficient enrollment practices

As part of our standard procedure, we admit alternate candidates for each cohort to ensure that all subjects are randomized on time and studies stay on schedule.

Patient retention

Ensuring patient retention and study compliance

OCRC has invested in creating a comfortable and supportive environment for our participants that fosters engagement and satisfaction. We show our commitment to patient well-being by providing:

Well-catered meals to accommodate diverse dietary needs
Convenient transportation to and from the facility
Entertainment and outdoor exercise options, as permitted by the protocol
Comfortable living facilities to maximize comfort and relaxation
Accommodating and friendly staff who create a welcoming atmosphere
Essential services such as laundry and toiletries

In addition, we take time to educate participants about their role in the study. This proactive approach helps to prevent dropouts and ensures steady, reliable participation, ultimately contributing to the success of your study.

Pharmacy

Advanced pharmacy capabilities and equipment for comprehensive trial support

Our pharmacy team, led by a licensed pharmacist and supported by skilled technicians, is dedicated to ensuring the integrity and safety of your investigational products. We offer a full range of services and use advanced equipment so we can provide reliable and efficient support throughout your clinical trial.

Capabilities

Compounding
Preparation of IV infusions and subcutaneous injections
Intranasal administration
Topical preparation and administration
IP packaging and labeling
IP storage
IP disposal

Equipment

Laminar flow hood for sterile preparations
Multiple refrigerators and freezers for IP storage
−80°C freezer for IP storage
Temperature-controlled environment
Continuous temperature monitoring tools

Laboratory

World-class laboratory services

OCRC is consistently recognized as one of the top recruiting sites, thanks to our robust, strategic approach to patient recruitment and enrollment. Here’s how we excel:

Efficient sample processing

We can process high-volume blood and urine samples, ensuring timely analysis and results.

Specialized handling

Our team is skilled in handling specialized samples, including those requiring flash freezing or specific processing techniques.

Reliable sample storage

Multiple −80°C freezers ensure the long-term stability of your valuable samples.

Robust infrastructure

Our laboratory is equipped with multiple centrifuges (both ambient and refrigerated), a generator backup system, and a daily supply of dry ice to maintain optimal sample integrity.

Quality assurance

We maintain meticulous records of sample harvest and quality control procedures to ensure data accuracy and regulatory compliance.

Services by external facilities

Access to specialized external services

OCRC has established strong partnerships with external facilities for specialized procedures, allowing us to schedule in advance and secure priority appointments to meet protocol timelines.

Available procedures include:

Monitoring facilities

Superior monitoring facilities for clinical research associates

Our dedicated monitoring facilities offer a comfortable and productive environment for Clinical Research Associates (CRAs). We provide: