Clinical Trials Services

At the heart of our program is our commitment to full-service, organized study management. From contract award to study closure, a highly qualified team with extensive training in protocol management, laboratory processes and client relations is responsible for oversight of each study and delivery of accurate data.

• Development and routine maintenance of customized, protocol-specific database.
• Preparation of customized, visit-specific kits and requisition forms for specimen collection.
• Preparation of laboratory reports in customized, sponsor-specific format.
• Customization of flagging specifications (alert values, inclusion/exclusion criteria, etc.).
• Preparation and distribution of customized investigator manuals.
• Preparation and distribution of customized collection kits.
• 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.
• Investigator support services
• Helpdesk
• Remote data access

LBM offers a broad array of tests and new procedures are implemented on a regular basis. State-of-the-art technology enables us to perform specialized dosages and tests in different fields of application.

Methodologies:

• Enzyme-linked immunosorbent assays (ELISA)
• Radioimmunoassays (RIA)
• Immunoradiometric assays (IRMA)
• Chemiluminescence immunoassays (CLIA)
• High performance liquid chromatography (HPLC)
• High performance liquid chromatography tandem mass spectrometry (HPLC-MS/MS)

Specialties:

• Clinical chemistry
• Hematology
• Immunology
• Endocrinology
• Microbiology
• Virology
• Toxicology
• Drug monitoring
• DNA analysis

• Testing performed in a timely and accurate manner
• Safety testing usually reported within 24-48 hours of receipt of specimen
• Same-day reporting of pathological results
• Consistent reference ranges
• Method validation
• Short-term or long-term specimen storage at -4ºC, –20ºC or –75ºC on the basis of specific project and/or sponsor needs.

• Customized Reports and Protocol-specific Database
• Data Transfer: to sponsor in sponsor-preferred format, scheduled or ad hoc
• Remote Data Access: secure access to results and reports
• Development and routine maintenance of customized, protocol-specific database
• 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.

• Customized laboratory reports in sponsor-specific format
• Customized flagging specifications (alert values, inclusion/exclusion criteria, etc.)
• Results reported as single and/or cumulative reports by fax, e-mail or courier service as per specific Study Agreements
• Secure remote access to results and reports

• Courier Services from LBM to Investigator Sites: visit-specific kits and supplies, manuals, shipping supplies & documents
• Courier services from Investigator Sites to LBM: top bulk couriers for safety testing; all other shipments are tailor-made specialty services, meeting specific timelines
• Courier services in Argentina, Chile, Uruguay, Colombia, Peru and Brazil