PHSU/PRI-CAIMED Center

Ponce Health Sciences University and Ponce Research Institute clinical trials research division, CAIMED Center, is the largest academic research center in the southwest area of Puerto Rico. Our research philosophy is to enhance patient care through participation in clinical trials. Participation in clinical trials provides access to advanced therapeutic alternatives, augments follow-up of medical problems, and eases the financial burden of health care for research subjects.

The center has 21 plus years of experience conducting phase 1-4 clinical trials (over 320 studies) in diverse therapeutic areas. These therapeutic areas include diabetes and metabolism, rheumatology, dermatology, cardiovascular diseases, renal disease and their complications, oncology, women’s health, CNS, pain control, pulmonary medicine, hepatitis, HIV infection, gastroenterology, and vaccine trials (adult, adolescent and pediatric).

Experienced investigators lead a team of study coordinators, research nurses, pharmacists, and medical technologists. Most studies conducted at the center are phase 1, 2 and 3, in all age groups, pediatric and adults.

The center is fully equipped, staffed, and certified to comply with all regulations as stipulated by ethical review boards, and all state and federal regulations.

Telephone Directory

(787) 840-2575    RECEPTION
(787) 840-2505    DIRECT LINE
(787) 840-2535    FAX

EMAIL: crc@psm.edu

CAIMED Personnel

Name Title Experiece at CAIMED Start date at CAIMED Phone Extension (787)-840-2575
CAIMED Center Director/Investigator
24 years
April 2000
Ext. 5637
Study Coordinator Supervisor
14.3 years
February 21, 2007
Ext. 5637
Study Coodinator/Contracts/Quality Manager
10.3 years
February 28, 2011
Ext. 5638
Medical Technologist
6.11 years
June 30, 2014
Ext. 5625
Administrative Assistant & Financing
5.11 years
June 29, 2019
Ext. 5640
Study Coordinator
5.1 years
April 11, 2016
Ext. 5636
Administrative Assistance & Financing/ Assistant Finance Office
5 years
May 13, 2016
Ext. 5623
Study Coordinator/ Lab Technician
4.5 years
December 05, 2016
Ext. 2186
Study Coordinator
3.7 years
October 23, 2017
Ext. 5641
Study Coordinator/ Nurse/ Unblinded Pharmacist
3.2 years
March 02, 2018
Ext. 5654
Study Recruiter/ Study Coordinator
2.10 years
July 28, 2018
Ext. 5656
Study Coordinator/ Nurse/ Unblinded Pharmacist
2 years
May 06, 2019
Ext. 5056
Medical Technologist
7 months
October 22, 2020
Ext. 5626
Study Coordinator/ Unblinded Pharmacist
7 months
October 22, 2020
N/A
Medical Technologist
7 months
October 22, 2020
N/A
Data Entry
7 months
October 22, 2020
Ext. 5667
Study Coordinator/ Nurse/ Unblinded Pharmacist
7 months
October 22, 2020
Ext. 5624
Administrative Assistant & Financing
5 months
December 22, 2020
Ext. 5623

Physical Facility

Office Quantity
Physician Offices
2
Patient Exam Rooms
5
Infusion Room
1
Patient Waiting Room
1
Study Coordinator Offices
7
Record Rooms
4
Monitor Rooms
2
Gynecology and Pediatric Exam Room
1
Laboratory/ Clinical Research Laboratory/ COMPASS Laboratory
2
Reception Area
1
Conference Room
1
Blood Drawing Room
1
Drug Storage Rooms
2
Blinded Record Room
1
Supply Room
1
Pharmacy Room/Clean Room
1
Storage Rooms
2

Measurements of CAIMED Center

Areas Measurements

Physicians’ Offices
Patient Exam
Study Coordinators Offices

61x47 Square Feet
Clinical Samples Lab
61x44 Square Feet
Monitor Rooms
13x11 Square Feet Each
Conference Room
15x19 Square Feet
Waiting Rooms

I - 14x12
II - 8x8 Square Feet

Drug Rooms
3x4 Square Feet Each
Record Rooms

I -   6 X 9 Square Feet
II – 6 X 12 Square Feet
III – 7 X 8 Square Feet
IV – 10 X 9 Square Feet
V - 3x4 Square Feet Each (Blinded Record Room)

Supply Room
8 X 22 Square Feet
Blood Drawing Room
12 X 8 Square Feet
Compass Lab (Research Building)
16 X 19 Square Feet

LABORATORY

  • Processing and Shipment of Research Samples
  • Processing of Peripheral Blood Mononuclear Cell (PBMC) research samples
  • Four (4) qualified staff members that can process and ship research samples.
  • Mandatory Laboratory Quality Assurance
    • Document developed to ensure that the quality of laboratory processes is evaluated and done according to protocols. Guide to evaluating the competencies of research samples being processed at the site including but not limited to Sed-rate, Urinalisis, and Pregnancy test.
  • Site has developed Standard Operating Procedures (SOP) for each process that is done within the CAIMED Laboratory and management of research samples. These are available upon request.
  • Laboratory freezers are monitored 24/7 by digital thermometer (Dickson) and/or Min/Max thermometer.  Temperature logging is done on paper log every morning Monday to Friday (except during Holidays). Digital thermometers (Dickson) can provide detailed temperatures for the 24-hour period, and provide email, text, phone, and audible alarm during temperature excursions. All thermometers being used are calibrated per site SOP.
  • Laboratory Equipment:
    • Centrifuge – Room Temperature/ Refrigerated (2)
    • Freezer – Minus 20° Centigrade (3)
    • Freezer – Minus -80º Centigrade (2)
    • Germfree Laboratories Incorporated Biological Type 2 Hood
    • Laboratory Work Bench
    • Incubator -80°
    • Refrigerator 2-8°
    • Hood Biohazard- biolevel 2 A2
    • 2 computers
    • 1 printer
    • Abbot ID now/ PCR machine
    • 2 CO2 tanks/ CO2 back-up for the freezer
    • Laboratory quality assurance and Quality Control in progress

PHARMACY

  • Receipt, storage and Preparation of Investigational Products (IP) per protocol requirements.
  • Storage of Blinded IP per protocol requirements to maintain blind.
  • Pharmacy area is restricted to qualified unblinded staff members.
  • Three (3) qualified RN (Registered Nurse) staff members that can store, prepare and administer IP.
  • Site has developed Standard Operating Procedures (SOP) for each process that is done within the CAIMED Pharmacy and management of IP. These are available upon request.
  • Pharmacy freezers/refrigerators are monitored 24/7 by digital thermometer (Dickson) and/or Min/Max thermometer.  All pharmacy freezers/refrigerators have a primary and a back-up monitoring device. Temperature logging is done on paper log every morning Monday to Friday (except during Holidays). Digital thermometers (Dickson) can provide detailed temperatures for the 24-hour period, and provide email, text, phone, and audible alarm during temperature excursions. All thermometers being used are calibrated per site SOP.
  • Temperature is also monitored 24/7 in the Pharmacy area (preparation room) by a Min/Max thermometer.
  • Pharmacy Equipment:
    • Refrigerator 2° to 8° Centigrade (3)
    • Refrigerator 4° to 25° Centigrade (1)
    • Vaccine Refrigerator 2º to 8º Centigrade (2)
    • Vaccine Freezer -15º to -25º Centigrade (2)
  • Pharmacy Quality Assurance and Quality Control in progress

EQUIPMENTS

OFFICE EQUIPMENT
  • Computers
  • Internet / Modem
  • Dedicated Fax Lines
  • Electronic Data Transfer Capabilities
Miscellaneous Equipment
  • desks
  • chairs
  • shelves
  • telephones/fax/scanners/photocopier
  • fire extinguishers
  • fire sprinklers
CLINICAL EQUIPMENT
  • Blood Drawing Chair (1)
  • Electrocardiogram Machine (1)
  • Blood Pressure Equipment
    • 4 wall mounted sphygmomanometer units
    • 3 digital pressure machines
    • 1 portable sphygmomanometer
      • one mercury sphygmomanometer
  • Tanita Weight Scales (2)
  • IV Pumps (1) / Syringe Pump (1)
  • Patient Infusion chairs (4)
  • Patient exam tables (5)
  • Pediatric Scale (1)
  • Pediatric Exam Tables (1)
  • Pediatric Baby Length Board (1)
  • Patient Thermometers (2)

Recruitment

  • CAIMED has a designated site recruiter to develop a monthly agenda that focuses on the specific recruitment needs of the site.
  • Regulated process for recruiting and enrolling subjects; in which the subject’s rights are protected and the integrity of the clinical trial is maintained.
  • The site focuses on the holistic care of our subjects; therefore, our recruitment provides information on various health conditions, providing guidance for better lifestyles, assessment of blood glucose and blood pressure, and offering our services to them or any acquaintance.
  • Recruitment Strategies:
    • Assessment of Site’s Patient Database
    • Community Outreach
    • Visiting Clinical Facilities such as hospitals and physician offices
    • Visiting Government agencies
    • Hosting or attending health fairs
    • Collaborating with organizations (such as PR Psoriasis Association, PR Diabetes Association, PR Endometriosis Association, etc.) by hosting year-round events
  • Site staff is qualified in Basic Life Support (BLS CPR). 
  • There is an established protocol for the verification and maintenance of the Crash Cart and AED.  This protocol is upheld by the site’s RNs.
  • Monthly verification of the emergency equipment is done by the site’s RNs to ensure that the equipment needs to manage any emergency is readily available.
  • The site has developed Standard Operating Procedures (SOP) for Emergency Management and Emergency Equipment. These are available upon request.

Emergency Management

  • CAIMED has a fully equip Crash Cart with the basic requirements to manage any clinical emergency. Also on site is an AED with adult and pediatric pads. An Oxygen tank is also placed near the Crash Cart.
  • Site staff is qualified in Basic Life Support (BLS CPR). 
  • There is an established protocol on the verification and maintenance of the Crash Cart and AED.  This protocol is upheld by the site’s RNs.
  • Monthly verification of the emergency equipment is done by the site’s RNs to ensure that the equipment need to manage any emergency is readily available.
  • Site has developed Standard Operating Procedures (SOP) for Emergency Management, and Emergency Equipment. These are available upon request.

Certificates of Training of Staff

  • Good Clinical Practice (National Institutes of Health)
  • NIH-DMID-CROMS Training
  • NIH Information Security Awareness Training
  • IATA Transportation of Dangerous Goods
  • Biohazard and Biomedical Waste Management
  • Use in Handling of Fire Extinguishers
  • Radioactive Safety Course
  • Certified Laboratory Animal Technician
  • IRB Compliance Courses
  • CPR Certified (physicians/nurse / staff)
  • HIPAA Law Compliance Course
  • Fundamentals of Clinical Research Coordination

Standard Operating Procedures

  • The site has developed, during its years of practice, various standard operating procedures (SOP) to ensure the upholding of good clinical practices and protocol requirements.
  • Site staff is required to comply with these SOPs and to use them as guides to ensure the quality of the procedures.
  • SOPs are kept in an indexed binder readily available upon request.  Since they are revised every two years, superseded SOPs are kept in a separate binder.  

Local Reference Laboratories

  • Laboratorio Clínico Toledo
  • INNO Diagnostics (HIV & Hepatitis Testing) PHSU

Quality Assurance/Quality Control

  • For NIH protocols
  • QA/ QC for laboratory and Pharmacy (in progress)

Patient Resource Available for Research

    • Referrals from Private Medical Offices
    • Multimed (Multidisciplinary Clinic)
    • CAIMED Database
    • Hospitals Affiliated with Ponce Health Sciences University
      • Damas Hospital – Ponce
      • San Lucas Hospital – Ponce
      • Dr. Pila Hospital – Ponce
      • San Cristobal Hospital – Ponce
      • Mayagüez Medical Center – Mayagüez
      • Concepción Hospital – San Germán
    • Ponce Health Sciences University
      • Mental Health Clinics
      • 400,000 Patient Data Base

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