Sponsors
For more information on our research site or Sponsor / CRO inquiries, please contact:
Tony Ortiz, Ph.D.
Scientific Director
(714) 335-3015
Christian Ortiz
Business Development Specialist
(949) 309-1725
You may also use the inquiry form below to contact us.
At a Glance
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Conduct phase I-IV inpatient and outpatient clinical studies for various medical and CNS indications
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14 bed inpatient facility with PK capabilities
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Able to "Fast-Track" study start-up by using centralized IRB and guaranteeing "First Patient-In" for various sponsors
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Strong history of exceeding contracted enrollment expectations
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Screen-failure rate varies between 12-25% depending on indication
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Completion rate is between 80-100%
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Raters are specifically trained to manage placebo-response
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Recruitment is focused around internal patient database and outpatient clinic--advertisement funds are rarely used
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Internal quality assurance group ensures proper conduct and documentation of studies
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GCP/ICH training is conducted at least twice per year
What We Do
We are a dedicated research facility in Southern California with a mission to obtain quality clinical research data in order to advance safe and effective therapeutics to the marketplace.
Our team of highly trained board-certified psychiatrists, psychologists, physicians, and experienced clinical research coordinators ensure that we obtain the best data possible for our sponsors. Our investigators and clinical staff adhere to the standards of GCP and ICH guidelines.
Our expertise has evolved into long-term inpatient trials for the diseased population that requires complex study procedures, such as pharmacokinetics (PK), pharmacodynamics (PD), cardiac safety, ascending dosages, food interaction, and mechanism of action.
We have developed investigator-initiated studies for various sponsors that incorporated polysomnography, high-field MRI and PET scans. We have assisted in the development of protocols and research designs for various trials.
Capabilities
Our 10,000 square foot dedicated research facility in Orange, Southern California includes the following:
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8 interview rooms for rating assessments
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14 bed inpatient facility with entertainment room and kitchen
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Neurocognition lab for neuropsychological assessment
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Exam rooms with calibrated EKG/vitals equipment
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Laboratory with a refrigerated centrifuge
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-20degrees and -70degrees freezers for PK samples
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Secondary laboratory dedicated for PK draws
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Entertainment room for patients participating in long visits and overnight stays
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Onsite infusions
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800 square foot double-locked drug room
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Dedicated monitoring suite to accommodate up to 12 monitors
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Crash cart on site
We have agreements with third party vendors to provide the following service:
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Magnetic Resonance Imaging (MRI) 1.5-3.0 Tesla
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Positron Emission Tomography (PET)
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Polysomnography
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Cardiology Consults
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Ophthalmology Consults
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Dermatology Consults
OUR SPONSORS
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OUR CROs
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