ABOUT CLINICAL trials

In 2002, the Stamboulian Group put great emphasis on research services to create the Clinical Trials Division, a division fully committed to providing support services to Researchers, CROs and Sponsors.

 

The Clinical Trials Division includes: 

  • A global central laboratory providing specialized laboratory testing services to CROs, pharmaceutical and biotechnological industries in support of clinical trials conducted in Argentina and Latin America.

  • A medical team entirely dedicated to designing, planning, conducting, controlling and documenting Medical Research Studies.

  • Major pharmaceutical companies trust in the quality and management of our Laboratory & Medical Research Studies.

  • Support teams for each defined protocol: Principal Investigators and Sub-Investigators, Study Nurses, Study Coordinators, Project Managers, Data Managers, Logistics Team, QC & QA Team.

  • Laboratory kits and Manuals of Standard Operating Procedures.

  • Customized reports for each protocol.

  • Storage of specimens and documentation.

  • Follow-up visits: Six Flags Alert.

  • Periodic and final reports with performance evaluation and performance metrics.

  • Domestic and International courier service.

We know the enormous value of clinical research results, more important, we know how to ensure solid and reliable data. This commitment leads us to combine scientific excellence and permanent academic vocation, with a strong customer service orientation.

Laboratory services

  • Project Management
  • Study-Specific Procedures
  • Investigator Manual
  • Investigator Training
  • Laboratory Documents, Supplies and Kits Production
  • Visits Follow-Up: Six-Flags Alerts
  • Performance Metrics
  • Interim and Final Statistical Reports
  • Long-Term Raw and Electronic Data Storage
  • Database Design and Validation
  • Double Data Entry
  • Daily Database Backup
  • Database Verification and Cleaning
  • Customized Reports
  • Flag Alerts on Out-of-Range Results
  • Daily Reporting: Fax and E-mail Based
  • Follow-Up Reports on Patients Results
  • Electronic Data Transfer Customized according to Sponsor Requirements
  • Compliance with 21 CFR Part 11 Guidelines
  • Statistical evaluation of data
  • Experience in all testing fields: Clinical Chemistry, Hematology, Coagulation, Urinalysis, Bacteriology, Mycology, Mycobacteriology, Virology, Immunology/Serology, Flow Cytometry, Molecular Biology, Pharmacogenomics
  • Extensive Routine and Esoteric Testing Menu
  • Multiple Analytic Platforms
  • Expertise to Develop a Flexible Test List
  • 24-48h Turn-around Time for Most Analytes
  • Long-Term Storage of Biological Specimens
  • National Services: Reception of Specimens from All over the Country
  • Regional Services: Latin America coverage
  • International Services: Shipments to USA and Europe
  • Compliance with IATA and Local Regulations

The Stamboulian Group is accredited under IRAM-ISO-15189:2014, the international standard that provides quality and competence requirements for medical laboratories.

Our aim is not only to provide accurate results, but also to do so with a reasonable turn-around time with traceability of all our procedures, a respect for ethics and to assure the safety of patients and staff alike.

In addition, to ensure accuracy and clinical utility of test results, our laboratory participates in the following External Quality Assurance Programs:

National Quality Assurance Programs

  • ProgBA – Centro de Educación Médica e Investigaciones Clínicas (CEMIC).
  • PEEC – Programa de Evaluación Externa de Calidad Fundación Bioquímica Argentina (FBA).
  • Programa Nacional de Control de Calidad en Bacteriología – Instituto Nacional de Enfermedades Infecciosas ANLIS “Dr. Carlos G. Malbrán”.

International Quality Assurance Programs

  • CAP -College of American Pathologists-
  • RIQAS RANDOX Laboratories

Interlaboratory Programs

  • Unity -BioRad-
  • Insight -Sysmex-

MEDICAL SERVICES

  • Seven readily accessible ambulatory centers in Buenos Aires City

  • Central Laboratory

  • Ample space for drug storage (locked ambient storage, locked refrigerator, 2 °C–8 °C)

  • Access to dry ice for storing and shipping specimens

  • Refrigeration units available: Refrigerators, -20 ° C freezers, -70 ° C freezers

  • Refrigerated centrifuge and ability to process lab specimens on-site

  • Back-Up Power Generators

  • Fully equipped Emergency kits

  • 12-lead ECG machine

  • High-speed internet access allowing use of electronic data capture (EDC) systems

  • Experience with EDC: Phase Forward Inform, Medidata RAVE and Oracle RDC

  • Site with experience using an external Central Laboratory

  • Staff trained on shipping hazardous goods

  • More than 15 years of experience in community vaccination
  • Continuously trained staff to assure the most efficient and the safest vaccination
  • Compliance with National and International Standards
  • Medical support available during vaccination procedures
  • Wide availability of vaccines
  • Fully controlled logistic and distribution systems
  • Fully controlled cold chain through cutting-edge technology
  • Cold chamber with high storage capacity, including an internal packaging area
  • GCP-ICH compliance
  • More than 50 Clinical Trials (phases II, III and IV) conducted
  • Broad experience in Antibiotics, Antiretrovirals, Pharmacokinetics and Vaccines trials
  • More than 2,500 patients and volunteers enrolled
  • Expertness in Pediatrics Studies
  • Trials sponsored by Pharmaceutical Industry, NIH, NPO
  • Comité de Ética en Investigación Clínica (CEIC)
  • Compliance with GCP-ICH
  • Weekly meetings
  • Trials evaluation average time: 1 – 2 weeks
  •  Accreditations:
    • Ministry of Health, Government of the City of Buenos Aires, Accreditation 031 – Disposition No. 276-DGDOIN / 2015
    • National Registry for Health Research (RENIS) Code CE000022
    • Office for Human Research Protection (OHRP) IRB Registration 00001678. U.S.A.

Contact us

Clinical Trials
Av. Scalabrini Ortiz 676 (C1414DNT)
Buenos Aires, Argentina
[email protected]
Laboratory Services
Cinthia Rainero, Biochemist
[email protected]
Medical Services
Diego Fridman, MD
[email protected]
Business Development
Alejandro Buasso
[email protected]

    Complete the form below with your comments or questions: