RESEARCH
FOR SPONSORS
OUR EXPERIENCE
Albuquerque Center for Rheumatology has been providing superior Rheumatology care to the residents of the State of NM since 1997. Our private practice has a combined clinical research experience of greater than 30 years. We are able to successfully recruit and often exceed our enrollment expectations due to day-to-day patient interactions and our extensive database of clinic patients. Up to ninety five percent of our subject recruitment is from our own clinic. Additionally, we conduct on-site quarterly Research Department meetings.
We have greater than 30 collaborative years experience in conducting Phase II-IV clinical trials and our site has conducted over 70 clinical trials in Rheumatology since 1999. We have extensive experience in Biologic and Biosimilar drug clinical trials.
Our Phase II-IV Clinical Drug/Device Trial Experience includes but is not limited to the following indications:
- Rheumatoid Arthritis (RA) Early, Moderate, Severe
- Psoriatic Arthritis (PsA)
- Systemic Lupus Erythematosus (SLE) (CLE)
- Ankylosing Spondylitis (AS)
- Gout
- Sjogren's Disease
- Osteoarthritis (Pain)
RESEARCH CERTIFICATION & TRAINING
Our Investigative staff as well as support staff maintain current certification/training in the following:
- GCP (CITI training every 2 years)
- IATA certified Study Coordinators
- Phlebotomy and IV certified Study Coordinators
- ACRP Certified or ACRP Eligible Study Coordinators
- ACRP/SOCRA membership
- On Site Standard Operating Procedures (SOPs)
- BLS certification
SITE EQUIPMENT
- Two dedicated InvestigationalProduct Refrigerators
- Dedicated Ambient IP storage
- Dedicated Exam room
- Dedicated Infusion Room
- Scheduling
- Emergency Medications
- Dedicated Monitoring Area
- Centrifuge
- Incubator
- -20° freezer
- Xray, MRI & Nuclear Imaging (off site)
- Access to dry ice
- ECG
- Urgent Care/Hospital 1 mile away
- Wireless Internet Access
- Fax/Copier
- Document Shredder
- Electronic and Paper medical records
- *SOP for monitor/auditor access*
- Secure source document storage
- Equipment calibration annually
INFORMED CONSENT (ICF)
- Dedicated private room for consent discussion
- SOP for consent procedures
- GCP guidelines are strictly enforced and followed for the informed consent process
OUTCOMES & EFFICACY ASSESSMENT EXPERIENCE
- Patient reported outcomes and study specific questionnaires
- Experience with paper blinded independent and tablet questionnaires
- Physicians are experienced with performing joint counts
- Experience with the following site and subject questionnaires/assessments: PGA sPGA SF-36 HAQ EQ-5D 5L QUIDS-SR-16 SPARCC LDI-B NAPSI PASI Itch NRS SLEDAI BILAG SLICC DLQI WPAI-SHP DAS SDAI FACIT PROMIS-29 LEI SPARCC BASDAI ESSDAI ESSPRI
- RA AND PsA assessments
INVESTIGATIONAL PRODUCT
- On site drug destruction per site SOP
- 24 hour min/max ambient and refrigerator temperature monitoring
- SOP for power outage
LAB COLLECTION & PROCESSING
- PK and Serial PK collection and processing
- TruCulture collection and processing
- Quantiferon TB Gold collection and processing
- Safety lab collection and processing
- PBMC, Flow cytometry, PAXGENE, BNP UA dipstick/Pregnancy Testing
- On Site ESR
- Cytodelic sample collection/processing
- Access to Dry Ice and Shipping
ON-SITE IV (INFUSION) FACILITY
- Area to accommodate IV and serial PK subjects comfortable for extended period of time
- IV bag preparation and administration experienced staff
- Continuous subject monitoring
REGULATORY / IRB
- On site regulatory management
- Site is able to utilize a Central IRB
- Experience in electronic submission and reporting
CONTRACT / BUDGET NEGOTIATIONS
- Handled at the site level
- Average time to contract execution 4-8 weeks
ELECTRONIC DATA CAPTURE / EDC / IWRS
Site experience with the following applications:
- ERT/Clario
- Firecrest
- BioClinica
- Oracle
- Medidata
- InForm
- Bracket
- Intralinks
- SIP
- SIS
- Greenphire
- Sponsor system
- Calyx
- Almac
- Cenduit
- DrugDev
- Safety Reporting systems
- Veeva
ADVERTISING
- Central Campaign
- Local Television, paper, radio and Billboard
- Outside Clinic Referrals
RECORD STORAGE
-
On-Site Record Storage
BROCHURE
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RESEARCH STAFF
PRINCIPAL INVESTIGATOR
Leroy Pacheco, M.D.
CO-INVESTIGATOR
Jacqueline Dean, M.D.
SITE DIRECTOR
Valarie Jackson, MA, ACRP-CP
CONTACT THE DEPARTMENT
PHONE
(505) 242-6190
ADDRESS
1617 University Blvd NE
Albuquerque, NM 87102
HOURS
Mon. - Fri. 7:30 AM - 4:30 PM