For Sponsors

For Sponsors

 

We are an independent, multi-specialty, physician investigator-owned clinic dedicated to Phase II-IV sponsored clinical trials. We have a demonstrated history of enrolling subjects quickly, producing quality data to Sponsors, and ensuring the highest standard of patient care.

Our largest area of study is in CNS (Neurology and Psychiatry) therapeutic trials. According to publicly available CMS data, Irvine Clinical Research is the leading independent site in Alzheimer’s Disease clinical trials, as measured by industry research grants, in the state of California.

Sponsors working with our site can expect:

  1. Two business day turnaround for regulatory documents, with one point of contact, a regulatory affairs specialist

  2. Two business day turnaround for budgets and contracts, with one point of contact, a contracts specialist with signatory authority

  3. Immediate availability to Principal Investigators for Project Management, CRAs, and other Sponsor/CRO contacts

  4. Using Sponsor's Central IRB, with no need for a local IRB

  5. Clinical Research Coordinators who have already been trained in multiple EDC systems

 

You can learn all about our key staff members on our about page. Get to know who they are and what they do to make a difference in the clinical research community.

Patient Demographics

 

Patients are recruited from database and chart reviews, in concert with marketing that draws from the Greater Los Angeles Area. Because of our high standard of care, we are able to retain more patients. Patients benefit from an ongoing relationship with our physicians, while Sponsors enjoy reduced advertising costs.

While we see patients from the pool of 13 million Los Angeles area residents, our city of Irvine is the leading business city in Orange County, the sixth most populous county in the US, and one of the most diverse. While best known for being the home of Disneyland, we are able to draw upon a diverse patient population that includes Caucasian, Latino, Asian, and African-American participants.

Our Facility

Our new multi-therapeutic site, built in 2016, is an outpatient center located in the Alzheimer's Orange County building, a community organization that reaches 25,000 people a year with educational outreach and support programs.

  • Multiple exam rooms

  • CLIA-Waived Laboratory

  • Certified, experienced phlebotomists

  • -20°, -70° Freezers, as well as refrigerator drug storage

  • Temperature-controlled, double-locked investigational drug storage

  • Temperature alert system monitored 24/7/365 with email/text alerts

  • Backup power generator

  • EKG/ECG - Electrocardiogram

  • Uroflow

  • Bladder Ultrasound

  • 24 hour emergency phone number

  • Dry Ice on site

  • Daily FedEx, UPS, and USPS pickup

  • On-site Records Storage, with long-term off-site records storage

  • Large conference room available for monitors, with a view of the Santa Ana mountains

  • Fax and copy machines available at any time to monitors

  • Free high-speed internet for patients, monitors, and guests - wired or wireless

  • Patient waiting area with HDTV, refreshments, and fresh coffee

We are also able to provide services through our affiliate partners upon request. Examples include but are not limited to: radiology scans (X-Ray, MRI 1.5T or 3T, CT, Amyloid PET, Tau PET, CSF/LP), DEXA, and sperm analysis. We have access to all major tracers used in Alzheimer’s Disease screening including florbetapir (Amyvid), florbetaben (NeuraCeq), flutemetamol (Vizamyl), flortaucipir (Tauvid), and MK-6240.

Irvine Clinical Research is 1.5 miles from Orange County/John Wayne Airport (SNA), a convenient airport with direct service to the East Coast. We are adjacent to I-405 (with freeway building signage). Parking is free and plentiful in a private lot. Alternative transportation is available as well.