Laboratorio Bioquímica Médica

Clinical Trial Services

 

LBM is an independent laboratory in Buenos Aires, Argentina, dedicated to clinical biochemistry applied to clinical trials for pharmaceutical companies. LBM is committed to accurate laboratory testing and rapid delivery of laboratory data, generated according to the highest quality standards. All procedures and methods are standardized and documented according to GLP (Good Laboratory Practices).

LBM Central Laboratory develops partnerships with clients and delivers value added services in the most cost-effective and efficient manners. Professional staff at LBM Central Laboratory takes pride in delivering accurate test results and meaningful clinical study information. Using internationally recognized Quality Systems and technology to support regional clinical research projects, LBM Central Laboratory strives to create an environment where customer satisfaction is ensured by the highest quality of our work and value added services.

LBM adheres strictly to all applicable local regulations governing clinical labs. LBM provides accurate results with properly documented reference ranges, guaranteeing the test procedures. LBM has actively participated in internal and external quality control programs for over 15 years.

All specimens are analyzed directly upon arrival and results are reported within 24-48 hours. Pathological results are reported the same day. Extensive proficiency available in clinical chemistry, hematology, immunology, endocrinology, microbiology, virology, toxicology, drug monitoring and DNA analysis.

Services in Latin America: Argentina, Brazil, Chile, Colombia, Mexico, Peru and Uruguay.

  • CLIA '88 compliant
  • Project Management
  • Consultation: on protocol laboratory issues and details
  • Investigator Meeting Attendance: presentation of laboratory aspects
  • Investigator support services - Investigator Manuals in Spanish
  • Help Desk: telephone and email helpdesk for sites
  • Supplying Investigator Sites: visit-specific kits and supplies, manuals, shipping supplies & documents
  • Courier services: from sites to lab. We use top bulk couriers for safety testing. All other shipments are tailor-made specialty services, meeting specific timelines
  • Sample Management: reception - collection - storage (short and long-term at -20ºC / -70ºC)
  • Results: test results to sites via fax or email within 24 hours - Same day reporting for pathological results
  • Consistent reference ranges
  • Customized Reports and Protocol-specific Database
  • Data Transfer: to sponsor in sponsor-preferred format, scheduled or ad hoc
  • Remote Data Access: access to reports through LBM's web site
  • Courier services in Argentina, Chile, Uruguay, Colombia, Peru and Brazil

Accreditations

Fundación Bioquímica Argentina (Lab Accreditation # C-0030) since 2001 in the following fields:

  • Laboratory General (Clinical Chemistry - Hematology)
  • Endocrinology
  • Therapeutic Drug Monitoring

College of American Pathologists (LAP # 6500601) since 1996 in the following fields:

  • Laboratory General
  • Hematology / Coagulation
  • Clinical Chemistry
  • Special Chemistry
  • Immunology
  • Urinalysis

CAP Accreditation means that the quality standards required for laboratories in the United States have been met, and these standards evidence a continuous quality improvement program. The College of American Pathologists (CAP) assesses accuracy of the methods used in the laboratory by means of its quality control program.

This program comprises continuous auditing of our laboratory by this institution by means of: a) a visit to our laboratory every 2 years by a CAP inspector; b) answers to our queries, which are assessed by CAP (Proficiency Testing). This assessment of the laboratory's performance is available to medical auditors for inspection.

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Quality Control

Our Laboratory is an active participant in internal quality control and external quality programs to guarantee quality and reliability of results reported.

Internal quality control

Our laboratory performs in-house quality control through application of international standards to each analyte tested.

External quality control:

Our laboratory participates in several external proficiency testing programs.

“Buenos Aires" (CEMIC) external proficiency testing program (since 1983) in the following areas:

  • Thyroid hormones
  • Antithyroid antibodies
  • Steroids
  • Tumor markers
  • Protein hormones

College of American Pathologists external proficiency testing programs (since 1996) in the following areas:

  • Hematology and clinical microscopy
  • Coagulation
  • Clinical Chemistry
  • Hormones
  • Immunosuppressive drugs
  • Tumor markers
  • Vitamins
  • Therapeutic drug monitoring
  • Viral markers
  • Proteins
  • Serology
  • Urinalysis (microscopic and urine chemistry)

Fundación Bioquímica Argentina (Argentine Biochemistry Foundation) external quality control program (PEEC) (since 2000) in the following areas:

  • Hematology
  • Clinical Chemistry
  • Instrument Control
  • Endocrinology (Thyroid hormones, Steroids, Proteins)
  • Therapeutic Drug Monitoring
  • Tumor Markers
  • Immunoserology
  • Glycated Hemoglobin

International Proficiency Testing, Analytical Unit, Department of Cardiological Sciences, St. George's Hospital Medical School, London, UK (since 2004):

  • SIROLIMUS (Rapamune)

Instand e.V (Germany) External Quality Assessment (since 2007) in the following areas:

  • Plasma/Urine Biogenic Amines (Dopamine - Adrenaline - Noradrenaline - Serotonine)
  • Screening of drugs of abuse in urine
  • Thyroid hormones
  • Vitamins (Folic Acid - Vitamin B12, 25 OH Vitamin D)
  • Fertility
  • Glycated hemoglobin
  • Therapeutic drug monitoring and immunosuppressive drugs (Lamotrigine - Mycophenolic acid)
  • Lipids/Lipoproteins
  • Immunology
  • Plasmatic proteins

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