Laboratorio Bioquímica Médica
Clinical Trial Services
PRE-ANALYTICAL STAGE
- Development and routine maintenance of customized, protocol-specific database in the Laboratory Information System.
- Preparation of customized, visit-specific kits and requisition forms for specimen collection.
- Preparation of laboratory reports in customized, sponsor-specific format.
- Customization of critical value alert and flagging program.
- Preparation and distribution of customized instruction manuals in English or Spanish, including detailed information on specimen collection, processing and transportation.
- Preparation and distribution of customized collection kits with specific bar code access number for every specimen required per visit.
- Shipping of emergency back-up supplies and replacement kits as necessary.
- Specimen Management: accuracy and acceptability of incoming specimens checked pursuant to regulatory requirements, accreditation standards, and protocol specifications.
- Courier Services: Shipping of collection kits from LBM Central Laboratory to the Study Sites and of specimens from the Study Sites to the lab will be handled by a commercial courier service or by LBM personnel.
ANALYTICAL STAGE
- Testing is performed upon reception of specimens at the lab.
- As per LBM’s Quality Control / Quality Assurance program, instrument calibration programs are executed and documented pursuant to internal and external QA programs and all testing and laboratory reports are accompanied by acceptable QC testing.
POST-ANALYTICAL STAGE
- Laboratory reports are printed and sent to destinations pre-determined by the sponsor per specific Study Agreements.
- All laboratory data, including hard copies of reports and electronic database are stored for a total of three years. Length of laboratory data storage time can be extended on the basis of specific project and/or sponsor needs.
- LBM offers short-term or long-term sample storage at -4ºC, –20ºC or –75ºC on the basis of specific project and/or sponsor needs.
OTHER SERVICES
- Investigator meetings are attended by a lab representative to present the laboratory aspects of the study. Ther personnel training session is also attended to ensure each person involved in the study has in-depth understanding of the laboratory aspects of the program.
- LBM will notify the investigator sites of critical values and/or other project-specific alert values.
- Dedicated in house study monitors are assigned to each protocol to assist the investigator in providing correct samples, requisitions and clean data, and to interact with the client on a daily basis. Management reports such as status and progress reports are sent to the sponsor on a regular basis.
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
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