Clinical Trails (CAIMED)
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.
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 |
|---|---|---|---|---|
| Elizabeth A. Barranco, MD | CAIMED Center Director/Investigator | 24 years | April 2000 | Ext. 5637 |
| Nancy Jimenez, MPH, RT | Study Coordinator Supervisor | 14.3 years | February 21, 2007 | Ext. 5637 |
| Michelle Irizarry, BA | Study Coodinator/Contracts/Quality Manager | 10.3 years | February 28, 2011 | Ext. 5638 |
| Armando X. Torres, MS, MT (ASCP) | Medical Technologist | 6.11 years | June 30, 2014 | Ext. 5625 |
| Yania Marrero, BBA, MBA | Administrative Assistant & Financing | 5.11 years | June 29, 2019 | Ext. 5640 |
| Irmaris Arroyo, MT (ASCP) | Study Coordinator | 5.1 years | April 11, 2016 | Ext. 5636 |
| Bryan Rosa, BBA | Administrative Assistance & Financing/ Assistant Finance Office | 5 years | May 13, 2016 | Ext. 5623 |
| Velma Franceschini, MT (ASCP) | Study Coordinator/ Lab Technician | 4.5 years | December 05, 2016 | Ext. 2186 |
| Brenda García, MT | Study Coordinator | 3.7 years | October 23, 2017 | Ext. 5641 |
| Sara Cancel, RN, BSN | Study Coordinator/ Nurse/ Unblinded Pharmacist | 3.2 years | March 02, 2018 | Ext. 5654 |
| Lydiet Dedós, BS, MBA | Study Recruiter/ Study Coordinator | 2.10 years | July 28, 2018 | Ext. 5656 |
| Alejandra Roman Bermúdez, RN, BSN | Study Coordinator/ Nurse/ Unblinded Pharmacist | 2 years | May 06, 2019 | Ext. 5056 |
| Marianne Hernandez, MT (ASCP) | Medical Technologist | 7 months | October 22, 2020 | Ext. 5626 |
| Juan D. Lugo, RN, BSN | Study Coordinator/ Unblinded Pharmacist | 7 months | October 22, 2020 | N/A |
| Frances Figueroa, MT | Medical Technologist | 7 months | October 22, 2020 | N/A |
| Jackeline Torres, BS | Data Entry | 7 months | October 22, 2020 | Ext. 5667 |
| Alice G. Rodriguez, RN, FNP, MSN | Study Coordinator/ Nurse/ Unblinded Pharmacist | 7 months | October 22, 2020 | Ext. 5624 |
| Francisco Roman, BBA | 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
Equipment
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