Overview

The exciting potential of translational medicine is driving discoveries that are focused on the genetics that make individuals and populations unique. But research methodologies are becoming complex. Scientists strive to uncover the biomarkers that cause human disease. Individuals must be screened to test a drug’s efficacy and safety in clinical trials. Brooks Life Science Systems supports the development of molecular diagnostic research with comprehensive sample management, storage, and analytical services that remove variables, reduce risk, and yield richer study results. Our laboratories screen patients for inclusion in clinical studies. And our tools, technologies, and services enhance discovery by performing genetic profiles that identify targets for new therapies. These unique attributes help empower biomedical researchers to push personalized medicine to the limits of what is possible — and beyond.

Typical Pathway

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Brooks Solutions

Pathway 1.jpg    Subject Identification

  • Study subjects are identified.
  • GCP sample collection kits are planned.
  • Study design is developed and validated.

Pathway 2.jpg    Assay Validation

  • Targeted analyses are developed and technology is selected.
  • Assay sensitivity/specificity is determined.
  • Control samples are assessed and identified.

Pathway 3.jpg    Sample Collection

  • GCP sample collection kits are produced with training materials, and control samples are sourced.
  • Samples are collected and transported to processing lab.

Pathway 4.jpg    Sample Processing

  • Researchers identify appropriate molecular, pathological, or cellular analyses (CLIA).
  • Proper technology is selected and sample processing is developed and validated (CLIA).
  • Integrated analytical and functional quality control is established.
  • Samples are processed and tracked in regulatory-compliant manner.

Pathway 5.jpg    Data Generation

  • Targeted analyses performed in CLIA environment.
  • TAT for patient reporting is defined.

Pathway 6.jpg    Data Reporting

  • Sample and control data is reported and tracked.

Pathway 7.jpg    Sample Storage

  • Storage environment is validated.
  • Regulatory-compliant storage processes are confirmed.
  • Proper storage tubes/plates and seals are selected.
  • Samples are stored in automated or manual systems QC metrics are established over time.

Pathway 8.jpg    Sample Distribution

  • Manage sample requests for additional analyses.
  • Prepare specific volume-based and normalized samples to facilitate additional analyses.
  • Track environmental conditions in transport.