AGA Clinical trials

Center Information

Dr. Roberto Aguirre CPI, CCRP
VP / Global Research Firector
AGA Clinical trials
900 W 49 St, Suite 430
Hialeah, FL 33012
USA
305-819-6990 X 8004
305-819-1559 (fax)
raguirre@agaclinicaltrials.com
www.agaclinicaltrials.com
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Currently Enrolling Trials

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Therapeutic Areas

Cardiology/Vascular Diseases
Dermatology
Devices
Endocrinology
Family Medicine
Gastroenterology
Healthy Volunteers
Infections and Infectious Diseases
Internal Medicine
Musculoskeletal
Neurology
Nutrition and Weight Loss
Obstetrics/Gynecology (Women’s Health)
Orthopedics/Orthopedic Surgery
Pediatrics/Neonatology
Pharmacology/Toxicology
Plastic Surgery
Psychiatry/Psychology
Pulmonary/Respiratory Diseases
Sleep
Urology
Vaccines

Center Overview

AGA CLINICAL TRIALS is a Multispecialty Mixed Facility with sites in South Florida and South America with 10 full time Clinical Research Coordinators with over 90 years of combined experience in metabolic, cardiovascular, dermatologic, neurological, men's and women's health, gastrointestinal, Cosmetics and vaccine studies. Also a Quality Assurance Manager, 2 part-time Clinical Research Coordinators, 2 full time Certified Phlebotomist,2 full time Recruitment Specialist, 2 Socra certified Sub-Investigators who has been involved in research during the last 15 years.

Our sites have 5 patient exam rooms, on-site laboratories with refrigerated and regular centrifuges, gram stain capabilities, two ECG machines, crash cart,Defibrillator, oxygen, emergency medication, secured long term storage area, temperature controlled, camera controlled drug room and refrigerator, -20 and -80 degree freezers, bolted double locked storage closets, calibrated scale, calibrated blood pressure cuffs, vestibular function test capabilities, ultrasound and Pulmonary function Testing.

We also have access to a very extensive database of approximately 8500 subjects with a variety of medical indications.

Our Demography is divided in 65% bilingual Hispanics, 20% African-Americans, 15 % Caucasians, office provides immigration services which eases recruiting of any type of Naive trials.

Aga Clinical Trials is proud to be part of CDCR to provide sponsors with a largest pool of minority Hispanic volunteers in the US.

Aga Clinical Trials has being selected as an Alliance partner by Parexel and Preferred site by Quintiles.

Aga Clinical Trials was invited to be part of the prestigious international research alliance ( Medical Research Alliance) since 2014 and Insearch since 2012.

We started working Pediatric Clinical Trials since 2011 and currently among the top 10 enrollers in Men B vaccine trials.

Comfortable and very friendly environment to accommodate up to 7 CRA's during monitoring visits, office closes late so after hours and Saturday site checks are readily available.

Site has Overnight stay capabilities with 10 beds and extended PK,First in human, MAD/SAD, PK/PD experience for Phase 1 trials in Pediatric and Adult population.

Previous research experience has being recognized in areas as Metabolic, Cardiovascular, Pain Management, Vaccines, Biosimilars, Women’s Health, Dermatology, Devices, Nutraceuticals among others.

We are proud to announce to our Sponsors/CRO that we opened a Site in Ecuador, South America since 2011, currently conducting trials for phase 2-4, which offers a Fast enrollment, reduced costs compared with trials conducted in US (30-35%), Bilingual personnel, Dollarized country and regulatory times of <60 days.

Large pool of patients (3000) which are opened to volunteer for clinical trials, recruitment is supported from our Board Certified Physicians in different areas from 2 of the largest public hospitals in South America.

Our facilities are fully functional, complete and ready for a Site Qualification Visit anytime you wish to come.

Performance Metrics

Number of Studies Conducted: 163
Number of Studies Actually Completed: 159
Number of Active Patients in the Database: 317
Regulatory Submission Turn-Around Time: 4 Business Day(s)
Average Number of Total Patients Enrolled: 35
Average Percent of Total Patients Randomized: 75%
Average Percent of ‘Completed’ Studies that met Enrollment Goals: 92%
EDC Capabilities: Yes

Staff Certifications
Number of Certified CRCs: 3
Number of Certified PIs: 2

ACRP Certifications

Clinical Research Experience

Our sites have 5 patient exam rooms, on-site laboratories with refrigerated and regular centrifuges, gram stain capabilities, two ECG machines, crash cart,Defibrillator, oxygen, emergency medication, secured long term storage area, temperature controlled, camera controlled drug room and refrigerator, -20 and -80 degree freezers, bolted double locked storage closets, calibrated scale, calibrated blood pressure cuffs, vestibular function test capabilities, ultrasound and Pulmonary function Testing. Access to a very extensive and diverse database of approximately 8500 subjects with a variety of medical indications. Our Demography is divided in 65% bilingual Hispanics, 20% African-Americans, 15 % Caucasians, office provides immigration services which eases recruiting of any type of Naive trials. Aga Clinical Trials is proud to be part of CDCR to provide sponsors with a largest pool of minority Hispanic volunteers in the US. Aga Clinical Trials has being selected as an Alliance partner by Parexel and Preferred site by Quintiles. Aga Clinical Trials was invited to be part of the prestigious international research alliance ( Medical Research Alliance) since 2014 We started working Pediatric Clinical Trials since 2011 and currently among the top 10 enrollers in Men B vaccine trials. Comfortable and very friendly environment to accommodate up to 7 CRA's during monitoring visits, office closes late so after hours and Saturday site checks are readily available. Site has Overnight stay capabilities with 10 beds and extended PK,First in human, MAD/SAD, PK/PD experience for Phase 1 trials in Pediatric and Adult population. Easy access by public transportation, Metro, MIA and FLL airport. Free Parking.

Facility Description

Our sites have 5 patient exam rooms, on-site laboratories with refrigerated and regular centrifuges, gram stain capabilities, two ECG machines, crash cart,Defibrillator, oxygen, emergency medication, secured long term storage area, temperature controlled, camera controlled drug room and refrigerator, -20 and -80 degree freezers, bolted double locked storage closets, calibrated scale, calibrated blood pressure cuffs, vestibular function test capabilities, ultrasound and Pulmonary function Testing.

Access to a very extensive and diverse database of approximately 8500 subjects with a variety of medical indications.

Our Demography is divided in 65% bilingual Hispanics, 20% African-Americans, 15 % Caucasians, office provides immigration services which eases recruiting of any type of Naive trials.

Aga Clinical Trials is proud to be part of CDCR to provide sponsors with a largest pool of minority Hispanic volunteers in the US.

Aga Clinical Trials has being selected as an Alliance partner by Parexel and Preferred site by Quintiles.

Aga Clinical Trials was invited to be part of the prestigious international research alliance ( Medical Research Alliance) since 2014.

We started working Pediatric Clinical Trials since 2011 and currently among the top 10 enrollers in Men B vaccine trials.

Comfortable and very friendly environment to accommodate up to 7 CRA's during monitoring visits, office closes late so after hours and Saturday site checks are readily available.

Site has Overnight stay capabilities with 10 beds and extended PK,First in human, MAD/SAD, PK/PD experience for Phase 1 trials in Pediatric and Adult population.

Easy access by public transportation, Metro, MIA and FLL airport. Free Parking.

Investigator Experience

Dario Altamirano, D.O
Board Certified in Family Practice and Emergency Medicine

Principal Investigator for 163 Multispeciality Phase 1-4 Trials to Date in Pharmaceuticals, Devices, Biosimilars, Nutraceuticals, Vaccines and Cosmetics.

Staff Expertise

Dr. Ximena Graber CPI, CCRP
CEO, Lead Coordinator, 11 Years of Experience

Dr. Roberto Aguirre CPI, CCRP
VP / Global Research Director, Lead CRC, 10 Years of Experience

Dario Altamirando D.O
Principal Investigator, 9 Years of Experience

Paola Diaz
Regulatory Specialist, 7 Years of Experience

Diana Arango
Lead CRC, 10 Years of Experience

Ana Gaitan
CRC, Lab Tech Specialist, 5 Years of Experience

Iran Mateu
Recruitment Specialist, 1 Year of Experience

Patient Demographics

65% Hispanics
20% African Americans
15% Caucasians

Largest Hispanic Minority in South Florida.

Other Information

Only Central IRB

Contact Center

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