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