The Clinical Research Office at PHSU. Innovating Research and Clinical Trials in Puerto Rico. Learn about our capabilities, Moffitt Cancer Center Collaboration, and the Puerto Rico Clinical Trials Network.

1. PONCE RESEARCHINSTITUTE
Clinical Research Office
CRO

2. MISSION STATEMENT
To strengthen PHSU clinical research by providing infrastructure, quality services,
and mentorship assisting new and established investigators through every stage of
the research process.
Our vision is to overcome the disparities in clinical research and treatment in
Puerto Rico by increasing the clinical research capacity and providing unique
research experiences to investigators, patients, and sponsors.
Mission
Vision

3. • Furthers the missions of PRI of ongoing research
in the basic, behavioral, public health and clinical
sciences.
• Guidance and operations
• Investigator and faculty experts
• Support to PRI scientist investigating new
therapies and new prevention options
• Access to premier medical researchers and diverse
patient populations
• Effective centralized start-up process for timely
execution
ABOUT THE CROClinical Research Office

4. Puerto Rico Clinical Trials Network
• The Moffitt Cancer Center partnership was
created to overcome the disparities in oncology
clinical research and treatment in the
Hispanic/Latino population as evidenced by
diagnosis at more advanced stages, barriers to
care, and underrepresentation in clinical cancer
trials.
• Partnership Objectives:
– Increase research capabilities
– World’s first tissue bank of Puerto Rican
tumors, and;
– Reduce health disparities in the treatment
of cancer in Hispanic patients
– Quality partner

5. Oncology Research Information Exchange Network (ORIEN)
• (ORIEN) is a unique research partnership
among North America’s top cancer centers
• Access to data is the key to cancer discovery
• Data sharing to guide discoveries
• Advancing precision-based therapy
• Founders: Moffitt Cancer, The Ohio State
University Comprehensive Cancer Center –
Arthur G. James Cancer Hospital and
Richard J. Solove Research Institute in
Columbus
• Leverage multiple data sources and match
patients to targeted treatments
RESEARCH

6. Integrated Services
• Clinical Research Office services:
– Biorepository for specimen processing and
storage
– Sponsored clinical research support
– Regulatory assistance with IRB/IACUC
submission and other compliance
measures
– Supporting faculty and investigators
participating in federally funded, pharma,
investigator-initiated clinical trials
– Point of contact to match faculty
investigators with clinical trials sponsors

7. Integrated Services
Study Development
• Feasibility
Assessments
• Grant Management
and Support
• Regulatory
Submissions (Central
or Local IRB)
• Investigator Selection
• Community
Engagement
Study Conduct
• Clinical Research Facilities
• Coordination
• Data Management
• Monitoring
• Research Pharmacy
• Regulatory Reviews
• Specimen Collection and Storage
• Sponsor Invoicing
• Staff Training
• Subject Payment Management
• Study Closeout
Study Activation
• Budget and Contract
Preparation
• Clinical Trial Team
• Regulatory and
IRB/IACUC Support
• Data Management
• Study Conduct
• Quality Assurance
• Financial
Management
• Recruitment
Planning

8. Ponce Research Institute Research Locations
CAIMED
• Ambulatory clinical
research center
(CAIMED)
• Largest clinical
research centers in
Southern Puerto Rico
• Over 300 Trials
Completed
Wellness Center
Capabilities:
• Ophthalmology
• Internal Medicine
• Family Medicine
• Rheumatology
• Mental health
• Psychiatry
• Pediatrics
• 4,000 visits a month
Hospitals
• San Lucas
• San Cristobal
• Manati Medical Center
• Mayaguez Medical Center
• Bella Vista
• Caribbean Cancer
Centers

9. Research Areas
Over 500 faculty members - experts in diverse therapeutic
areas:
• Oncology * Infectious Diseases
• Endocrinology * Drug Abuse
• Endometriosis * Gastroenterology
• Genetics * Mental Health
• Surgery * Pediatrics
• Family Medicine * Internal Medicine
• Radiology * Emergency
• Basic Science * Cardiology
• Nephrology * Neurology

10. Inno Diagnostics Lab

11. Immunology Reference Laboratory
The primary goal of the CRO-Biorepository is to collect a variety of valuable biological
specimens from investigator-initiated studies and/or pharma to support clinical research.
CRO-Biobank equipment:
• -80°C freezers
• -20°C freezers
• -70 °C freezers
• Ambient Centrifuge
• Refrigerated Centrifuge
• Liquid Nitrogen Storage
• Backup
Power/Generator CRO-Biobank services:
• Specimen procurement and storage
• Specimen processing
• Specimen retrieval/distribution

12. CLIA certified specialty areas:
• Hematology
• Immunology
• Virology
CLIA: Clinical Laboratory
Improvement Amendments
Laboratory Specialty

13. Capacity and Reach
Ongoing projects
• Molecular epidemiology of HIV migration
• Feasibility of implementing NGS-based
genotyping
• Training and implementation of “In House”
genotyping
Educationand Training

14. Examples of studies for which our Lab has provided
support
• Detection of post-hurricane leptospirosis cases through enhanced surveillance for acute
febrile illness in southern Puerto Rico
• Dengue virus immunity in endemic and non-endemic human cohorts
• Clinical and Neurodevelopmental Outcomes of Postnatally - acquired Zika Virus
Infection among Children Aged <5 years
• Effects of Prefrontal Microglia Activation on PTSD-like Behaviors
• Targeting the Brain-Gut-Flora Axis using Probiotics in Endometriosis
• ARBO-004: Zika virus sero-prevalence and assessment of the Dual Path Platform® Zika
IgM assay to detect recent or current Zika virus infection

15. Inno Diagnostics Lab Technology

16. 3730 XL DNA Analyzer
• 48-capillary 3730 XL DNA Analyzer used for DNA
fragment analysis applications such as
microsatellites, AFLP, SNP analysis, mutation
detection and traditional DNA sequencing.
• In our laboratory:
– HIV-1 DR Genotyping
– HIV-1 Integrase Genotyping
– HLA SNP rs2395029 Analysis
– HCV 5’NC Genotyping

17. The MiSeq System: Next-Generation Sequencing
• Base calls are made directly from signal
intensity measurements during each cycle,
greatly reducing raw error rates compared to
other technologies.
• Microbiome Analysis

18. Flow Cytometry
• FACSCalibur: use of multiple fluorochromes
(FITC/PE/PerCP/APC) to effectively identify
and isolate subset populations in a single
sample.

19. BD FACSAria I: Cell Sorter
• Enables multicolor analysis of up
to 10 fluorescents markers and
two scatter parameters at the
same time. We have the capacity
to separate 4 subsets of cells at
the same time.

20. Luminex MAGPIX
• The Luminex MAGPIX analyzer detects up
to 50 analytes per sample and reads a 96-
well-plate in just 60 minutes. The
procedure could be performed by using as
little as 25µl of samples.

21. Mission U120 Ultra-Used to perform urinalysis of ten
parameters
• Leukocytes
• Specific Gravity
• Nitrite
• Ketone
• Urobilinogen
• Bilirubin
• Protein
• Glucose
• pH
• Blood

22. Hematology: AC.T 5diff AL
• Perform Complete Blood Cell (CBC) count
and differential analysis
• Hemoglobin, Hematocrit, MCV, MCH,
MCHC, RDW, Platelet Count, MPV

23. Data Core
Computer center administrated by our own network system
Used for
SPSS Statistics Use for data analysis
Nuance Power
PDF Advanced
Use for create or edit pdf documents
WM Recorder Use for recording streaming video and audio. Schedule recording for webinar,
create demonstration videos for any software program. The recorder is
available in Google Drive Storage for access by authorized personnel.
IMAC PRO
(RISE)
Use for analysis NGS Data
Work Centre
Xerox 4250
Print, Copy, Fax and Network Scan

24. GLU, UA, CHO, TG, BUN, TBIL, CA, TP ,ALB, ALT,
AST, CPK, AMY, GGT, ALP, Crea, Fructosamine,
Phosphorus, Magnesium, LDH, HDL, LDL
Panels: Lipid panel: TG, CHO, HDL
Basic Panel 1: ALB, BUN, GLU, CRE, CAL
Basic Panel 2: ALP, T-Bil, ALT, AST, T-Pro
• PBMC isolation:
isolation of cells
at the required
concentration,
cell count,
viability analysis
• Phlebotomy and
sample
processing
Other Services

25. Meet the Team
Roberto Torres, DHA
Director, Clinical Research
Office
Email: rtorres@psm.edu
Phone: 214-564-4869
Tacia M. Torres
Senior Grant Writer
Laura Domenech, MD
Senior Medical Officer
María E. Rojas, Pharm. D, MS
Senior, Clinical Research
Coordinator
Jessica Echevarria
Clinical Research Office
Operations Specialist/Regulatory
Inno Diagnostics
Dr. Vanessa Rivera Amil
Scientific Director
Glendaliz Melendez
Clinical Research Coordinator
Julia Batista
Clinical Research Coordinator
Mercedes Negron,
Clinical
Research Coordinator
Marta Villareal, PhD
Research Program Coordinator
Carmen Narvaez,
Clinical Research Coordinator