Services - Clinical Trials Division - CTDS | Centros Medicos Stamboulian

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Laboratory Services

STUDY SUPPORT

        - Project Management
        - Regulatory affairs
        - 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

DATA MANAGEMENT

        - 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
        - On-line results on web site
        - Follow up reports on patients results
        - Electronic Data Transfer customized according to sponsor requirements
        - Compliance with 21 CFR Part 11 guidelines
        - Data statistical evaluation

TESTING

        - Experience in every testing field: Clinical Chemistry, Hematology, Coagulation,
          Urinalysis, Bacteriology, Mycology, Mycobacteriology, Virology,
          Immunology/Serology,
          Flow Cytometry, Molecular Biology, Pharmacogenomics
        - Extensive menu of routine and esoteric testing
        - Multiple analytic platforms
        - Expertise to develop a flexible test list
        - 24-48h turnaround time for most analytes
        - Long-term sample storage

DISTRIBUTION AND LOGISTIC

        - Samples reception from all over the country
        - National services
        - Regional services: Latin America coverage
        - International services: shipments to USA and Europe
        - Compliance with IATA certification and local regulations

Medical Services

STRUCTURE

        - Five readily accessible ambulatory centers in Buenos Aires
        - Exclusive facilities for research
        - Large and comfortable waiting rooms
        - Local Labs in all centers for sample handling
        - Central Lab

EQUIPMENT

        - Fully controlled refrigerators
        - -20ºC freezers at all facilities
        - -70ºC freezers at Central Lab
        - Back Up Power Generators
        - Fully equipped Emergency kits
        - Safe boxes and cabinets
        - SOPs
        - High speed broadband Internet connection in all centers

VACCINES

        - More than 15 years of experience in community vaccination
        - Continuously trained staff to assure the most efficient and the safest vaccination
        - National and International Standard regulations compliance
        - Medical support available during vaccination procedures
        - Wide availability of vaccines
        - Fully controlled logistic and distribution systems
        - Fully controlled cold chain with last generation technology
        - Cold chamber with high storage capacity, including an internal packaging area

RESEARCH EXPERIENCE

        - GCP-ICH compliance
        - 50 Clinical Trials phases II, III and IV performed and ongoing
        - Broad experience in Antibiotics, Antiretrovirals, Pharmacokinetics and Vaccines trials
        - 2,500 patients and volunteers enrolled
        - Expertness in Pediatrics Studies
        - Trials sponsored by Pharmaceutical Industry, NIH, NPO

INSTITUTIONAL REVIEW BOARD

Ethic Committee FUNCEI – Helios Salud
        - GCP-ICH compliance
        - Weekly meetings
        - Trials evaluation average time: 1 – 2 weeks
        - 25 studies evaluated during 2007-2008 period

ORGANIZATION