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I would like to take this opportunity to introduce myself , my name is Roberto Aguirre MD CPI,CCRP; I started in the clinical research field 9 years ago with the help of very proficient Researchers as Dario Altamirano D.O and Dr.Maria Graber CPI,CCRP , after my accomplishments as a Foreign Physician. I have set up and trained a highly qualified team in South Florida and South America with 10 full time Clinical Research Coordinators with over 70 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 10 years.

Our sites have 5 patient exam rooms, on-site laboratories with refrigerated and regular centrifuges, gram stain capabilities, two ECG machines, crash cart, oxygen, emergency medication, secured long term storage area, temperature controlled, camera controlled drug room and refrigerator, -20 and -70 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 7000 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.

We started doing 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 and extended PK experience in Phase 1 Pediatric and Adult population.

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 120 days.

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

Our facilities are fully functional, complete and ready for a site check anytime you wish to come.

If we may be of any further assistance please do not hesitate to contact us via phone or email.

Thank you in advance for your consideration,


Roberto Aguirre MD, CPI, CCRP
Global Research Director
 

Information

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2007
  • Phases of clinical studiesPhase I, Phase II, Phase III, Phase IV
  • Types of studiesBiologics, Drugs, Medical Devices, Nutraceuticals, Vaccines
  • PopulationsChild 2-10 yrs, Adolescent 11-17 yrs, Adult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of sitePart of a practice
  • # of employees involved in research7
  • # of investigators2
  • Number of studies last year25
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday, Saturday
  • 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, Other
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsPAOLA DIAZ
  • Regulatory phone number3058191551X8007
  • # of days to turn around regulatory documents3
  • Type of IRB used by this siteCentral
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract1 WEEK DEPENDING ON SPONSOR FEEDBACK

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