Laboratorio Bioquímica Médica

Clinical Trial Services

 

Project Management

At the heart of our program is our commitment to full-service, organized study management. From contract award to study closure, a dedicated team is responsible for oversight of each study and delivery of accurate data files. Our staff is thoroughly trained in protocol management, laboratory processes and client relations.

Project Managers develop detailed project plans at project onset, with all tasks, timelines and milestones delineated. They monitor these plans and document progress to share with the sponsor, and to ensure strict adherence to protocol deadlines.

We proactively work with investigator sites to expedite every aspect of subject data collection, sample logistics and reporting. Our team provides investigator sites with training in the use of all clinical supplies and materials.

Quality and documentation are critical to the success of the study and are fundamental in our project management. We confirm that all necessary validation and quality control procedures are in place and monitored throughout the trial.

Certifications

  • CAP Laboratory Accreditation since October 1996
  • Laboratory certified by the Fundación Bioquímica Argentina since 2001 (Lab Certification # C-0030) - Republic of Argentina

LBM is accredited by the College of American Pathologists in the following fields:

  • Hematology
  • Clinical Chemistry
  • Urine Test
  • Special Chemistry
  • “In vitro” nuclear medicine, including hormones and tumor markers
  • Therapeutic drug monitoring

Accreditation by the CAP 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.

College of American Pathologists external proficiency testing programs in the following areas:

  • Endocrinology
  • Tumor Markers
  • Proteins - Immunoglobulins
  • Vitamins
  • Drug Monitoring
  • Hematology - Coagulation
  • Urinalysis
  • Serology
  • Chemistry

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

  • Endocrinology
  • Tumor Markers
  • Serology
  • Virology

Fundación Bioquímica Argentina (Argentine Biochemistry Foundation) external proficiency testing programs, since 2000, in the following areas:

  • Endocrinology
  • Tumor Markers
  • Drug Monitoring
  • Immunoserology
  • Chemistry
  • Urinalysis

Instand e.v  (Germany) external proficiency testing program, since May 2007, in the following areas:

  • Clinical Chemistry
  • Glicated proteins
  • Lipids
  • Pregnancy and Fertility