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PRCCI

Not-for-profit consortium of 22 top quality research sites in Puerto Rico covering all trial phases across 20 therapeutic areas

PRCCI

PRCCI is a not for profit 501(c)(3), non-exclusive, consortium of 22 research centers across the FDA-regulated US Territory of Puerto Rico, including 3 Universities, a chain of hospitals, a cooperative of primary care physicians and many specialty or multi-specialty clinical research centers covering more than 20 therapeutic areas. We strive to enhance and promote clinical research in Puerto Rico for our patients, our researchers, the Puerto Rican economy, and the sponsors and CROs.

We are making Puerto Rico a more attractive clinical research destination by providing a single point of contact with the sponsor/CRO for all our members, centralizing start up operations for fast and efficient study start up, deploying a common CTMS across all members, undertaking billing/invoicing and budget reconciliation, liaising/troubleshooting during the study as needed, and, most importantly, by applying rigorous, externally validated and enforced, quality standards as a prerequisite for any member to receive a study via PRCCI. We are also applying proactive, internal, risk-based monitoring for any study sourced via PRCCI with Yale University's YCCI being our external quality partner conducting the monitoring visits.

In addition to the capacity and capability building for clinical research, we administer training (GCP/ITP via partnering with Transcelerate members and best clinical research practices with Yale University, 300 already trained) and online sharing of best practices tools for our sites/members.

Entering our second year of operations and having already executed 13 CTAs with 9 of our members, we expand our scope to address patient empowerment /engagement, as well as health IT for research.     

Web Site: www.prcci.org 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2016
  • Phases of clinical studiesPhase I, Phase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Nutraceuticals, Vaccines
  • PopulationsInfant 0-1yr, Child 2-10 yrs, Adolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of siteFreestanding
  • # of investigators60
  • Number of studies last year13
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, UPS, DHL
  • REGULATORY INFORMATION 
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract5

Contact

  • Kosmas Kretsos
    Kosmas  Kretsos

    Executive Director
    Puerto Rico Consortium for Clinical Investigation
    San Juan, Puerto Rico